System and method for processing and transmitting sensor data

Abstract

Systems and methods are provided for processing, transmitting, and displaying data received from an analyte sensor, such as a glucose sensor. Data may be displayed on a handheld display device (16) having a display (608), such as a fob device (14) that includes a user interface (such as an LCD (602) and one or more buttons (604)) that allows a user to view the data, and a physical connector (such as a USB port (606)).

Description

[0001] This application is a divisional application of a patent application with an application date of September 21, 2012, application number 202010807320.3, and invention name “System and method for processing and transmitting sensor data”.

[0002] Cross-references to related applications

[0003] This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61 / 538,447, filed on September 23, 2011, the disclosure of which is expressly incorporated herein by reference in its entirety and is expressly made a part of the present application herein. Technical Field

[0004] The present invention generally relates to systems and methods for processing, transmitting, and displaying data received from an analyte sensor, such as a glucose sensor. Background Art

[0005] Diabetes is a disorder in which the pancreas does not produce enough insulin (Type I or insulin dependence) and / or in which insulin is ineffective (Type 2 or non-insulin dependence). In the diabetic state, the sufferer suffers from high blood sugar levels that cause a number of physiological disturbances associated with the degeneration of small blood vessels (renal failure, skin ulcers, or bleeding into the vitreous of the eye). Hypoglycemic reactions (hypoglycemia) may result from accidental overdoses of insulin or following normal doses of insulin or glucose-lowering medications with abnormal exercise or inadequate food intake.

[0006] Conventionally, diabetics carry self-monitoring blood glucose (SMBG) monitors that typically require an uncomfortable finger-pricking method. Due to the lack of comfort and convenience, a diabetic will typically measure his or her glucose level only two to four times a day. Unfortunately, these time intervals are spread so far apart that the diabetic will likely discover too late the dangerous side effects that may occasionally result from hyperglycemia or hypoglycemia. In fact, not only will it be impossible for the diabetic to obtain a timely SMBG value, but the diabetic will also not know based on conventional methods whether his blood glucose value is rising (higher) or falling (lower).

[0007] Therefore, a variety of non-invasive, transdermal (eg, percutaneous) and / or implantable electrochemical sensors are being developed for continuously detecting and / or quantifying blood glucose levels. These devices generally transmit raw or minimally processed data for subsequent analysis at a remote device that may include a display. Summary of the invention

[0008] Details of one or more implementations of the subject matter described in the specification are set forth in the accompanying drawings and the following description. Other features, aspects, and advantages will become apparent from the description, drawings, and claims. Note that the relative dimensions of the following drawings may not be drawn to scale.

[0009] In a first aspect, a method is provided for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide a user with access to analyte values ​​and / or information derived from the analyte values, comprising: activating a transceiver of the first communication device associated with the analyte sensor at a first time; using an authentication scheme to establish a two-way communication channel with the second communication device; using the two-way communication channel to send analyte sensor data to the second communication device; deactivating the transceiver of the first communication device at a second time; and periodically repeating the activation, establishment, sending, and deactivation, wherein the difference between the first time and the second time is less than or equal to one minute, and wherein the periodic repetition is performed at least once every 30 minutes.

[0010] In an embodiment of the first aspect, activating comprises supplying power to the transceiver, and wherein deactivating comprises powering down the transceiver.

[0011] In an embodiment of the first aspect, activating comprises waking the transceiver from a low power sleep mode, and wherein deactivating the transceiver comprises placing the transceiver in an even lower power sleep mode.

[0012] In an embodiment of the first aspect, the method further comprises closing the bidirectional communication channel before deactivating the transceiver.

[0013] In an embodiment of the first aspect, the difference between the first time and the second time corresponds to a transmission time window, and wherein the analyte sensor data corresponds to a new glucose measurement obtained before the beginning of the time window, and wherein the beginnings of consecutive time windows are separated by an update time interval.

[0014] In an embodiment of the first aspect, the method further comprises periodically measuring the analyte sensor value prior to periodically repeating each of activating, establishing, transmitting, and deactivating.

[0015] In an embodiment of the first aspect, the analyte sensor value comprises glucose concentration.

[0016] In another aspect related to the first aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of any one or more of the first aspect and / or its embodiments, wherein the system comprises a sensor electronics module incorporating a transceiver, the sensor electronics module being configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

[0017] In a second aspect, a method is provided for authorizing the exchange of analyte sensor data between a first communication device associated with an analyte sensor and a second communication device configured to provide a user with access to analyte values ​​and / or information derived from the analyte values, comprising: sending a challenge value from the first communication device associated with the analyte sensor to the second communication device; generating a first hash value in the second communication device at least in part using the challenge value, an identifier of the first communication device, or one or more of a key value; sending the first hash value from the second communication device to the first communication device; using the first communication device to generate a second hash value and a third hash value; using the first communication device to compare the second hash value and the third hash value with the first hash value; and sending the analyte sensor data only if at least one of the second hash value or the third hash value matches the first hash value.

[0018] In an embodiment of the second aspect, the method further includes determining a type of the second communication device based on a match between the first hash value and the second hash value or a match between the first hash value and the third hash value.

[0019] In an embodiment of the second aspect, the key value is a first value if the second communication device is of a first type, and wherein the key value is a second value if the second communication device is of a second type.

[0020] In an embodiment of the second aspect, the type of the second device corresponds to one of a primary device or a secondary device, wherein the primary device is configured to communicate the analyte calibration data to the first communication device, and wherein the first communication device is configured to reject the analyte calibration data received from the secondary communication device.

[0021] In an embodiment of the second aspect, the first hash value is generated using a display identifier.

[0022] In an embodiment of the second aspect, sending the analyte sensor data includes sending the analyte sensor data based at least in part on a type of the second communication device.

[0023] In another aspect related to the second aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of any one or more of the second aspect and / or its embodiments, wherein the first communication device comprises a sensor electronics module, and wherein the sensor electronics module is configured to electronically couple to an analyte sensor and generate an analyte data stream using the analyte sensor.

[0024] In a third aspect, a method is provided for transmitting data between a first communication device associated with an analyte sensor and one or more second communication devices configured to provide a user with access to analyte values ​​and / or information derived from the analyte values, comprising: receiving a request from a second communication device among the one or more second communication devices to establish a channel for receiving analyte sensor data from the first communication device during a transmission window; and establishing a communication channel between the first communication device and the second communication device if the number of communication devices that previously received analyte sensor data from the first communication device during the transmission window is below a threshold.

[0025] In an embodiment of the third aspect, the second communication device comprises a secondary communication device.

[0026] In one embodiment of the third aspect, the method also includes: determining whether the second communication device is a primary communication device; and if the second communication device is the primary communication device, establishing a communication channel with the second communication device even if the number of communication devices that previously received analyte sensor data during the transmission window is equal to or greater than a threshold.

[0027] In another aspect related to the third aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of any one or more of the third aspect and / or its embodiments, wherein a first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

[0028] In a fourth aspect, a method is provided for transmitting data between a first communication device associated with an analyte sensor and one or more second communication devices configured to provide a user with access to analyte values ​​and / or information derived from the analyte values, comprising: establishing a communication channel with only a primary device among the one or more second communication devices during a first time period within a communication window; and establishing a communication channel with one or more secondary devices among the one or more second communication devices only during a second time period different from the first time period.

[0029] In another aspect related to the fourth aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of the fourth aspect and / or any one or more of its embodiments, comprising: a sensor electronics module configured to establish a communication channel with a primary device and to establish a communication channel with one or more secondary devices.

[0030] In a fifth aspect, a method is provided for synchronizing the time for transmitting data between a first communication device associated with an analyte sensor and a primary communication device and a secondary communication device configured to provide a user with access to an analyte value and / or information derived from the analyte value, the method comprising: receiving a beacon from the first communication device at the primary communication device during a transmission time window defined by the first communication device; establishing a first communication channel between the primary communication device and the secondary communication device; transmitting beacon information from the primary communication device to the secondary communication device, wherein the beacon information includes timing information for establishing a communication channel with the first communication device; and establishing a communication channel between the first communication device and the secondary communication device based on the beacon information.

[0031] In an embodiment of the fifth aspect, establishing the first communication channel between the primary communication device and the secondary communication device includes performing an authentication protocol between the primary communication device and the secondary communication device.

[0032] In an embodiment of the fifth aspect, the first communications device is configured to periodically transmit beacons in a series of periodic transmission time windows separated by update time intervals.

[0033] In an embodiment of the fifth aspect, the timing information comprises information about a time corresponding to a start of the transmission time window.

[0034] In another aspect related to the fifth aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of the fifth aspect and / or any one or more of its embodiments, wherein a first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

[0035] In a sixth aspect, a method is provided for processing data from an analyte sensor and transmitting the data between a first communication device associated with the analyte sensor and a second communication device configured to provide a user with access to analyte values ​​and / or information derived from the analyte values, comprising: activating an analyte sensor data processing circuit and deactivating a transceiver of the first communication device associated with the analyte sensor during a first time interval; obtaining and processing analyte sensor data during the first time interval; deactivating the analyte sensor data processing circuit and activating the transceiver of the first communication device during a different second time interval; and transmitting the analyte sensor data to the second communication device during the second time interval.

[0036] In an embodiment of the sixth aspect, activating and deactivating the analyte sensor data processing circuit comprises powering up and down the analyte sensor data processing circuit.

[0037] In an embodiment of the sixth aspect, activating and deactivating the analyte sensor data processing circuit comprises activating and deactivating a low power mode of the analyte sensor data processing circuit.

[0038] In an embodiment of the sixth aspect, activating and deactivating the transceiver includes powering the transceiver on and off.

[0039] In an embodiment of the sixth aspect, activating and deactivating the transceiver includes activating and deactivating a low power mode of the transceiver.

[0040] In another aspect related to the sixth aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of the sixth aspect and / or any one or more of its embodiments, wherein a first communication device comprises a sensor electronics module configured to be electronically coupled to an analyte sensor.

[0041] In a seventh aspect, a method for processing data from an analyte sensor is provided, comprising: obtaining and processing analyte sensor data using an analyte sensor data device associated with the analyte sensor during a first time interval; opening a transmission time window to accept a request to establish a communication channel to communicate with the analyte sensor data device during a different second time interval, wherein the first time interval and the second time interval do not overlap.

[0042] In another aspect related to the seventh aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of the seventh aspect and / or any one or more of its embodiments, wherein a first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

[0043] In an eighth aspect, a method is provided for providing analyte sensor measurement values ​​from a first communication device associated with an analyte sensor to a second communication device configured to provide a user with access to analyte values ​​and / or information derived from the analyte values, the method comprising: receiving from the first communication device a request from the second communication device for previous analyte sensor measurement values ​​other than analyte sensor measurement values ​​for a predetermined analyte sensor measurement value transmission; and transmitting from the first communication device to the second communication device a data set of analyte sensor measurement values ​​corresponding to a predetermined time interval including the requested previous analyte sensor measurement values.

[0044] In one embodiment of the eighth aspect, the previous analyte sensor measurements comprise a subset of the data set of analyte sensor measurements.

[0045] In one embodiment of the eighth aspect, the predetermined time interval corresponds to a twenty-four hour period of analyte sensor measurements.

[0046] In another aspect related to the eighth aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of the eighth aspect and / or any one or more of its embodiments, wherein a first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

[0047] In a ninth aspect, a method is provided for transmitting data between a first communication device associated with an analyte sensor and a primary communication device and a secondary communication device configured to provide a user with access to analyte values ​​and / or information derived from the analyte values, comprising: establishing a communication channel between the secondary communication device and the first communication device during a transmission time window of a sensor session; determining whether the primary communication device has previously communicated with the first communication device during the sensor session; and if the primary communication device has not yet communicated with the first device during the sensor session, rejecting a request for data or a command sent by the secondary communication device to the first communication device.

[0048] In an embodiment of the ninth aspect, the communication between the primary communication device and the first communication device includes control information for initiating a sensor session.

[0049] In another aspect related to the ninth aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of the ninth aspect and / or any one or more of its embodiments, wherein a first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

[0050] In a tenth aspect, a method for transmitting data between a first communication device associated with an analyte sensor and a primary communication device and a secondary communication device is provided, each of the primary communication device and the secondary communication device being configured to provide a user with access to an analyte value and / or information derived from the analyte value, including: determining whether a first communication channel has been established between the first communication device and the primary communication device during a time window; and only if the first communication channel is established during the time window, establishing a second communication channel between the first communication device and the secondary communication device during the time window.

[0051] In another aspect related to the tenth aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of the tenth aspect and / or any one or more of its embodiments, wherein a first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

[0052] In an eleventh aspect, a method is provided for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide a user with access to an analyte value and / or information derived from the analyte value, comprising: switching the first communication device between multiple transmission window states, the multiple window transmission modes comprising: a first transmission window state, in which the first communication device does not open a transmission window, a second transmission window state, in which the first communication device periodically opens a transmission window at a first frequency, and a third transmission window state, in which the first communication device periodically opens a transmission window at a second frequency less than the first frequency; and transmitting one or more beacons during each transmission window state.

[0053] In an embodiment of the eleventh aspect, the first communication device switches from the first transmission window state to the second transmission window state upon actuation of a Hall effect switch or a reed switch.

[0054] In an embodiment of the eleventh aspect, the first communications device automatically switches from the second transmission window state to the third transmission window state in response to determining that the first communications device and the second communications device are successfully paired.

[0055] In one embodiment of the eleventh aspect, the first communications device automatically switches from the second transmission window state to the third transmission window state in response to determining that pairing has not been successful after a predetermined amount of time since switching from the first transmission window state to the second transmission window state.

[0056] In an embodiment of the eleventh aspect, the first frequency is about 30 seconds and the second frequency is about 5 minutes.

[0057] In another aspect related to the eleventh aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of the eleventh aspect and / or any one or more of its embodiments, wherein a first communication device comprises a sensor electronics module, wherein the sensor electronics module is configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

[0058] In a twelfth aspect, a method is provided for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide a user with access to analyte values ​​and / or information derived from the analyte values, the method comprising: storing technical support data in a log file in a memory in the first communication device; determining that the second communication device should receive at least some of the stored technical support data; using the first communication device to transmit a message indicating the determination; receiving a request for at least some of the stored technical support data from the second communication device in response to the transmitted message; and transmitting at least some of the stored technical support data.

[0059] In an embodiment of the twelfth aspect, the message is included in a beacon transmitted by the first communications device.

[0060] In an embodiment of the twelfth aspect, the message consists of bits.

[0061] In another aspect related to the twelfth aspect, a system for monitoring an analyte level of a host is provided, the system being configured to perform the method of the twelfth aspect and / or any one or more of its embodiments, wherein a first communication device comprises a sensor electronics module, wherein the sensor electronics module is configured to electronically couple to an analyte sensor and use the analyte sensor to generate an analyte data stream. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Figure 1 is a diagram illustrating one embodiment of a continuous analyte sensor system including a sensor electronics module.

[0063] Figure 2Ais a perspective view of a sensor system according to one embodiment, the sensor system including a mounting unit and a sensor electronics module attached to the mounting unit.

[0064] Figure 2B yes Figure 2B Side view of the sensor system.

[0065] Figure 3 is an example block diagram illustrating various elements of one embodiment of a continuous analyte sensor system and display device.

[0066] Figure 4A is a flow diagram of example communications between an analyte sensor system and a display device for communicating glucose measurements.

[0067] Figure 4B is a timing diagram of an example sequence for establishing a communication channel between an analyte sensor system and a display device.

[0068] Figure 5 is a flow chart of an example method for sending glucose measurements from an analyte sensor system to a display device.

[0069] Fig. 6A Provides an example of mapping alphanumeric characters to five-bit binary values.

[0070] Figure 6B Provides examples of mapping 35-bit values ​​to device numbers and transmitter IDs.

[0071] Figure 7 is a flow chart illustrating one embodiment of aspects of a process for pairing a transmitter and a receiver.

[0072] Figure 8 is a flow chart of an example method for establishing an authenticated communication channel between an analyte sensor system and a primary or secondary display device.

[0073] Fig. 9 is a timing diagram illustrating an example scheme for exchanging data between an analyte sensor system and multiple display devices.

[0074] Fig.10 is a flow chart of an example method for communication between an analyte sensor system and a secondary display device.

[0075] Fig.11 is a flow chart of an example method for providing sensor transmission time window information from a primary display device to a secondary display device.

[0076] Fig. 12A is a timing diagram of an example timing scheme for transmitting data and obtaining and processing analyte sensor measurements.

[0077] Fig. 12B is a flow chart of an example method for interleaving analyte sensor measurement and processing periods with data communication periods for transmitting glucose measurements.

[0078] Fig.13A An example of a data structure including glucose measurements that may be stored on an analyte sensor system is shown.

[0079] Fig. 13B is a flow chart of an example method of transmitting sensor data from an analyte sensor system to a display device. DETAILED DESCRIPTION

[0080] The following description and examples specifically illustrate some exemplary embodiments of the disclosed invention. Those skilled in the art will recognize that there are many variations and modifications thereof that are encompassed by the scope of the present invention. Thus, the description of a certain exemplary embodiment should not be considered to limit the scope of the present invention.

[0081] definition

[0082] To aid in understanding the systems and methods disclosed herein, a number of terms are defined below. The terms defined below, as well as other terms used herein, should be interpreted to include the definitions provided, the ordinary and customary meanings of the terms, and any other implied meanings used for the corresponding terms. Therefore, the following definitions do not limit the meanings of these terms, but only provide example definitions.

[0083] The term "analyte" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, a substance or chemical constituent in a biological fluid (e.g., blood, tissue fluid, cerebrospinal fluid, lymph, or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and / or reaction products. In some embodiments, the analyte used to be measured by the sensor head, device, and method is an analyte. However, other analytes are also contemplated, including but not limited to acarboxyprothrombin; acylcarnitines; adenine phosphoribosyltransferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profile (arginine (tricarboxylic acid cycle), histidine / urocanic acid, homocysteine, phenylalanine / tyrosine, tryptophan); androstenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotinidase; biopterin; C-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β-hydroxy-cholic acid; Cortisol; Creatine kinase; CK MM isozyme; Cyclosporin A; d-Penicillamine; Desethylchloroquine; Dehydroepiandrosterone sulfate; DNA (acetylase polymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne / Becker muscular dystrophy, analyte-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber's hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax vivax), sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diphtheria / tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids / acylglycines; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free triiodothyronine (FT3); fumarylacetoacetase; galactose / galactose -1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; analyte-6-phosphate dehydrogenase; glutathione; glutathione peroxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyltransferase; immunoreactive trypsin; lactate; lead; lipoprotein ((a), B / A-1, beta); lysozyme; mefloquine; netilmicin; phenobarbitone;Phenytoin; phytanic acid / pristanic acid; progesterone; prolactin; prolyl peptidase; purine nucleoside phosphorylase; quinine; trans-triiodothyronine (rT3); selenium; serum pancreatic lipase; sisomicin; somatomedin C; specific antibodies (adenovirus, antinuclear antibody, anti-ζ antibody, arbovirus, pseudorabies virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani donovani), Leptospira, Measles / Mumps / Rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, Parainfluenza virus, Plasmodium falciparum, Poliovirus, Pseudomonas aeruginosa, Respiratory syncytial virus, Rickettsia (tsutsugamushi), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi / Trypanosoma rangeli, vesicularstomatis virus, Wuchereria bancrofti bancrofti), yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. In some embodiments, salts, sugars, proteins, fats, vitamins, and hormones naturally present in blood or interstitial fluids may also constitute analytes. Analytes may be naturally present in biological fluids, such as metabolites, hormones, antigens, antibodies, and the like. Alternatively, analytes may be introduced into the body, such as contrast agents for imaging, radioisotopes, chemical reagents, fluorocarbon-based synthetic blood, or drugs or pharmaceutical compositions, including but not limited to insulin; ethanol;Marijuana (cannabis, THC, marijuana powder); inhalants (nitric oxide, amyl nitrite, butyl nitrite, chlorinated hydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamine, methamphetamine, Ritalin, pemoline, phendimetrazine, benzphetamine hydrochloride, PreState, chlorphentermine hydrochloride, Sandrex, benzdimetrazine); sedatives (barbiturates, methaqualone, tranquilizers such as diazepam, chlordiazepoxide, meprobamate, sedatives such as chlordiazepoxide, chlordiazepoxide, chlorpheniramine, chlordiazepoxide, sedatives such as chlorpheniramine, chlordiazepoxide, sedatives such as chlorpheniramine, chlorpheniramine, sedatives such as ... urea, chlordiazepoxide); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, pethidine, percocet, oxycodone, hydrocodone cough suppressants, fentanyl, darfen, valproate, lomotil); designer drugs (fentanyl, pethidine, amphetamine, methamphetamine, and analogs of phencyclidine, such as acetaminophen); anabolic steroids; and nicotine. Metabolites of drugs and drug combinations are also contemplated analytes. Analytes generated in the body such as neurochemicals and other chemicals such as ascorbic acid, uric acid, dopamine, norepinephrine, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovaline acid (HVA), 5-hydroxytryptamine (5HT), and 5-hydroxyindoleacetic acid (FHIAA) can also be analyzed. ;

[0084] The term "A / D converter" as used herein is a broad term and shall be given its ordinary and customary meaning to persons of ordinary skill in the art (and shall not be limited to a special or customized meaning), and shall also refer to, without limitation, hardware and / or software that converts analog electrical signals into corresponding digital signals.

[0085] The terms "processor module", "microprocessor" and "processor" as used herein are broad terms and will be given their ordinary and customary meanings to those of ordinary skill in the art (and will not be limited to special or customized meanings), and also refer to but are not limited to computer systems, state machines, etc. that perform arithmetic and logical operations using logic circuit devices that respond to and process basic instructions that drive the computer.

[0086] As used herein, the term "sensor data" is a broad term and will be given its ordinary and customary meaning for those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, any data associated with a sensor (such as a continuous analyte sensor). Sensor data includes a raw data stream or a simple data stream of an analog or digital signal (or other signal received from another sensor) directly related to the measured analyte from an analyte sensor, as well as calibrated and / or filtered raw data. In one example, the sensor data includes digital data in "counts" converted by an A / D converter from an analog signal (such as voltage or ampere) and includes one or more data points representing glucose concentration. Therefore, the terms "sensor data point" and "data point" generally refer to a digital representation of sensor data at a specific time. The term broadly covers a plurality of timed data points from a sensor (such as from a substantially continuous glucose sensor), the timed data points including individual measurements taken at intervals ranging from a fraction of a second to, for example, 1, 2 or 5 minutes or longer. In another example, the sensor data includes an integrated digital value representing one or more data points averaged over a time period. The sensor data may include calibrated data, smoothed data, filtered data, transformed data, and / or any other data associated with a sensor.

[0087] The term "calibration" as used herein is a broad term and is to be given its ordinary and customary meaning to persons of ordinary skill in the art (and is not to be limited to a special or customized meaning), and also refers to, without limitation, the process of determining a relationship between a raw data stream and corresponding reference data that can be used to convert the raw data into calibrated data (defined below). In some embodiments (such as continuous analyte sensors), calibrations such as calibrations may be updated or recalibrated over time when changes in the relationship between the raw data and the reference data occur, for example, due to changes in sensitivity, baseline, transmission, metabolism, etc.

[0088] The terms "calibrated data" and "calibrated data stream" as used herein are broad terms and will be given their ordinary and customary meanings to those of ordinary skill in the art (and will not be limited to special or customized meanings), and also refer to, without limitation, data that has been transformed from its original state to another state using a function (e.g., a transformation function) to provide meaningful value to a user.

[0089] The terms "smoothed data" and "filtered data" as used herein are broad terms and will be given their ordinary and customary meanings to those of ordinary skill in the art (and will not be limited to special or customized meanings), and also refer to, without limitation, data that has been modified, for example by performing a moving average of the original data stream to make it smoother and more continuous and / or to remove or attenuate irrelevant points. Examples of data filters include FIR (finite impulse response), IIR (infinite impulse response), moving average filters, etc.

[0090] The terms "smoothing" and "filtering" as used herein are broad terms and will be given their ordinary and customary meanings to those of ordinary skill in the art (and will not be limited to special or customized meanings), and also refer to, without limitation, mathematical calculations that attenuate or normalize components of a signal, such as reducing noise errors in a raw data stream. In some examples, smoothing refers to modifying a data stream to make it smoother and more continuous or to remove or attenuate irrelevant data points, such as by performing a moving average of the raw data stream.

[0091] The term "noise signal" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, signals associated with noise on a data stream (e.g., non-analyte-related signals). For example, the noise signal can be determined by filtering and / or averaging. In some embodiments, the noise signal is a signal residual, an incremental residual (difference in residuals), an absolute incremental residual, etc., as described in more detail elsewhere herein.

[0092] The term "algorithm" as used herein is a broad term and is to be given its ordinary and customary meaning to those skilled in the art (and is not to be limited to a special or customized meaning), and also refers to, but is not limited to, the computational process (associated with computer programming or other written instructions) involved in transforming information from one state to another.

[0093] The term "matched data pair" as used herein is a broad term and will be given its ordinary and customary meaning to one of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers without limitation to reference data (e.g., one or more reference analyte data points) that matches substantially time-corresponding sensor data (e.g., one or more sensor data points).

[0094] The term "count" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, a unit of measurement of a digital signal. In one example, the raw data stream measured in counts is directly related to a voltage (e.g., converted by an A / D converter), which is directly related to the current from the working electrode. In another example, the counter electrode voltage measured in counts is directly related to a voltage.

[0095] The term "sensor" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, any device (or portion of a device) that measures a physical quantity and converts it into a signal that can be processed by analog and / or digital circuitry. Thus, the output of a sensor can be an analog and / or digital signal. Examples of sensors include analyte sensors, glucose sensors, temperature sensors, altitude sensors, accelerometers, and heart rate sensors.

[0096] The term "glucose sensor" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customary meaning), and also refers without limitation to any sensor (e.g., enzymatic or non-enzymatic) by which glucose can be quantified. For example, some embodiments of a glucose sensor may utilize a membrane containing glucose oxidase, which catalyzes the conversion from oxygen and glucose to hydrogen peroxide and gluconate as shown in the following chemical reaction:

[0097] Glucose + O 2 → Gluconate + H 2 O 2

[0098] Since for each glucose molecule metabolized, there is a coreactant O 2 and product H 2 O 2 Since the glucose concentration is proportional to the change in the co-reactant or product, the electrodes can be used to monitor the latest change in the co-reactant or product to determine the glucose concentration.

[0099] The terms "coupled", "operably connected" and "operably linked" as used herein are broad terms and will be given their ordinary and customary meanings to those of ordinary skill in the art (and will not be limited to special or customized meanings), and also refer to, without limitation, one or more components being directly or indirectly linked to another (multiple) components in a manner that allows signals to be transmitted between the components. For example, modules of a computing device that communicate via a common data bus are coupled to each other. As another example, one or more electrodes of a glucose sensor can be used to detect the amount of glucose in a sample and convert that information into a signal (e.g., an electrical or electromagnetic signal); the signal can then be transmitted to an electronic circuit. In this case, the electrode is "operably linked" to the electronic circuit device, although the analog signal from the electrode is transmitted and / or transformed by the analog and / or digital circuit device before reaching the electronic circuit. These terms are broad enough to include wireless connectivity.

[0100] The term "physically connected" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customary meaning), and also refers to, without limitation, one or more components that are connected to another component(s) by direct contact and / or wired connection (including connection via one or more intermediate physically connected components). For example, a glucose sensor may be physically connected to a sensor electronics module and thus physically connected to a processor module located therein, either directly or via one or more electrical connections.

[0101] The term "substantially" as used herein is a broad term and is to be given its ordinary and customary meaning to persons of ordinary skill in the art (and is not to be limited to a special or customary meaning), and also refers without limitation to a large extent, but is not necessarily specified as exhaustive.

[0102] The term "host" as used herein is a broad term and is to be given its ordinary and customary meaning to those of ordinary skill in the art (and is not to be limited to a special or customized meaning), and also refers to, without limitation, mammals, such as humans, into which the device is implanted.

[0103] The term "continuous analyte sensor" as used herein is a broad term and will be given its ordinary and customary meaning to one of ordinary skill in the art (and will not be limited to a special or customary meaning), and also refers to, without limitation, a device or portion of a device that continuously or constantly measures the concentration of an analyte, for example, over time intervals ranging from a fraction of a second to, for example, 1, 2, or 5 minutes or longer. In an example embodiment, the glucose sensor includes a continuous analyte sensor such as described in U.S. Patent 7,310,544, which is incorporated herein by reference in its entirety.

[0104] The term "continuous analyte sensing" as used herein is a broad term and will be given its ordinary and customary meaning to one of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers without limitation to a period of time during which monitoring of an analyte is performed continuously or constantly, e.g., at time intervals ranging from a fraction of a second up to, e.g., 1, 2, or 5 minutes or longer. In one embodiment, a glucose sensor performs continuous analyte sensing to monitor glucose levels in a corresponding host.

[0105] The terms "reference analyte monitor," "reference analyte meter," and "reference analyte sensor" as used herein are broad terms and are to be given their ordinary and customary meaning to one of ordinary skill in the art (and are not to be limited to a special or customized meaning), and also refer, without limitation, to devices that measure the concentration of an analyte and can be used as a reference for a continuous analyte sensor, for example a self-monitoring blood glucose meter (SMBG) can be used as a reference for a continuous glucose sensor for comparison, calibration, etc.

[0106] The term "clinical acceptability" as used herein is a broad term and will be given its ordinary and customary meaning to persons of ordinary skill in the art (and will not be limited to a special or customized meaning), and refers to, without limitation, the determination of the risk of inaccuracy to a patient. Clinical acceptability can take into account deviations between glucose measurements corresponding in time (e.g., data from a glucose sensor and data from a reference glucose monitor) and the risk associated with the deviation (e.g., for decision making for a diabetic patient) based on the glucose values ​​indicated by the sensor and / or the reference data. An example of clinical acceptability can be that 85% of the analyte values ​​in a given set of measured analyte values ​​are within the "A" and "B" regions of a standard Clarke error grid when comparing sensor measurements to standard reference measurements.

[0107] The term "calibration quality" as used herein is a broad term and will be given its ordinary and customary meaning to one of ordinary skill in the art (and will not be limited to a special or customized meaning), and refers to, without limitation, the statistical association of matched data pairs in a calibration set used to create a transfer function. For example, an R value may be calculated for a calibration set to determine its statistical data association, where an R value greater than 0.79 determines a statistically acceptable calibration quality, while an R value less than 0.79 determines a statistically unacceptable calibration quality.

[0108] The term "sensor session" as used herein is a broad term and will be given its ordinary and customary meaning to persons of ordinary skill in the art (and will not be limited to a special or customized meaning), and refers to, but is not limited to, a period of time during which a sensor is in use, such as but not limited to the time period beginning at the time the sensor is implanted (e.g., in a host) to the time the sensor is removed (e.g., the sensor is removed from the host's body and / or the sensor electronics module is removed from the sensor housing).

[0109] The terms "noise," "noise events," "noise segments," "signal artifacts," "signal artifact events," and "signal artifact segments" as used herein are broad terms and are to be given their ordinary and customary meanings to those of ordinary skill in the art (and are not to be limited to special or customized meanings), and also refer to, but are not limited to, signal noise that is substantially non-glucose related, such as interfering species, macro- or micro-motion, ischemia, pH changes, temperature changes, pressure, stress, or even unknown mechanical, electrical and / or biochemical noise sources, for example.

[0110] The term "measured analyte value" as used herein is a broad term and will be given its ordinary and customary meaning to one of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers without limitation to an analyte value or set of analyte values ​​for a time period for which an analyte sensor has measured analyte data. The term is broad enough to include sensor data from an analyte sensor before or after data processing (e.g., data smoothing, calibration, etc.) in the sensor and / or receiver.

[0111] The term "estimated analyte value" as used herein is a broad term and will be given its ordinary and customary meaning for those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, an analyte value or set of analyte values ​​that have been algorithmically inferred from measured analyte values. In some embodiments, the estimated analyte value is estimated for a time period during which no data exists. However, the estimated analyte value may also be estimated during a time period during which the data measured exists, but will be replaced by data that is algorithmically inferred (e.g., processed or filtered), for example, due to noise or time lag in the measured data.

[0112] The term "calibration information" as used herein is a broad term and will be given its ordinary and customary meaning to a person of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, any information useful in the calibration of a sensor. The calibration information may include, for example, reference data (including one or more reference data points) received from a reference analyte monitor, one or more matched data pairs formed by matching reference data (e.g., one or more reference glucose data points) with substantially time-corresponding sensor data (e.g., one or more consecutive sensor data points), a calibration set formed from a set of one or more matched data pairs, a calibration line drawn from a calibration set, in vitro parameters (e.g., sensor sensitivity), and / or a manufacturing code.

[0113] The term "alarm" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, a reminder or signal, such as an auditory, visual, or tactile signal, triggered in response to one or more alarm conditions. In one embodiment, hyperglycemia and hypoglycemia alarms are triggered when current or predicted clinical risk is assessed based on continuous analyte data.

[0114] The term "transformed sensor data" as used herein is a broad term and will be given its ordinary and customary meaning to a person of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, any data derived in whole or in part from raw sensor data from one or more sensors. For example, raw sensor data over a period of time (e.g., 5 minutes) may be processed to generate transformed sensor data including one or more trend indicators (e.g., 5-minute trends). Other examples of transformed data include filtered sensor data (e.g., one or more filtered analyte concentration values), calibrated sensor data (e.g., one or more calibrated analyte concentration values), rate of change information, trend information, acceleration rate information, sensor diagnostic information, location information, alarm / alert information, calibration information, etc.

[0115] The term "sensor information" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, information associated with measurements, signal processing (including calibration), alarms, data transmission, and / or displays associated with a sensor (such as a continuous analyte sensor). The term is broad enough to include raw sensor data (one or more raw analyte concentration values) as well as transformed sensor data. In some embodiments, the sensor information includes displayable sensor information.

[0116] As used herein, the term "displayable sensor information" is a broad term and will be given its ordinary and customary meaning to a person of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, information that is transmitted for display on one or more display devices. As discussed elsewhere herein, the content of the displayable sensor information transmitted to a particular display device can be customized for a particular display device. In addition, the formatting of the displayable sensor information can be customized for the respective display device. The displayable sensor information may include any sensor data (including raw sensor data, transformed sensor data) and / or any information associated with measurements, signal processing (including calibration) and / or reminders associated with one or more sensors.

[0117] The term "data packet" as used herein is a broad term and will be given its ordinary and customary meaning to a person of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, a combination of data transmitted to one or more display devices, such as in response to a triggering reminder. A data packet may include displayable sensor information (e.g., already selected and formatted for a particular display device) and header information (e.g., data indicating a delivery address, communication protocol, etc.). According to an embodiment, a data packet may include a plurality of data packets transmitted separately to a display device (and reassembled at the display device) or a single data block transmitted to a display device. Data packets may be formatted for transmission via any appropriate communication protocol, including any WLAN communication standard in a wireless local area network (WLAN) communication standard including IEEE 802.11, 802.15, 802.20, 802.22, and other 802 communication protocols, and / or a proprietary communication protocol.

[0118] The term "direct wireless communication" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, the transmission of data from one device to another without any intermediate data processing (e.g., data manipulation). For example, direct wireless communication between a sensor electronics module and a display device occurs when sensor information transmitted from the sensor electronics module is received by the display device without intermediate processing of the sensor information. The term is broad enough to include wireless communications transmitted through routers, repeaters, telemetry receivers (e.g., configured to retransmit sensor information without additional algorithmic processing), and the like. The term is also broad enough to include data format transformations (e.g., via a Bluetooth receiver) that do not substantially transform the sensor information itself.

[0119] The term "look-ahead algorithm" as used herein is a broad term and will be given its ordinary and customary meaning to one of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, without limitation, algorithms that process sensor information in real time (e.g., continuously and / or periodically as sensor data is received from a continuous analyte sensor) and provide real-time data output (e.g., continuously and / or periodically as sensor data is processed in a sensor electronics module).

[0120] The term "backtracking algorithm" as used herein is a broad term and will be given its ordinary and customary meaning to those of ordinary skill in the art (and will not be limited to a special or customized meaning), and also refers to, but is not limited to, algorithms that backtrack and process sensor information (e.g., analyzing data sets for time periods prior to the current time period).

[0121] As used herein, the following abbreviations apply: Eq and Eqs (equivalent); mEq (milliequivalent); M (molar); mM (millimolar); μΜ (micromolar); N (equivalent); mol (mole); mmol (millimole); μmol (micromole); nmol (nanomolar); g (gram); mg (milligram); μg (microgram); Kg (kilogram); L (liter); mL (milliliter); dL (deciliter); μL (microliter); cm (centimeter); mm (millimeter); μm (micrometer); nm (nanometer); h and hr (hour); min. (minute); s and sec. (second); °C (degrees Celsius).

[0122] Overview

[0123] In some embodiments, a system for continuously measuring an analyte in a host is provided, the system comprising: a continuous analyte sensor configured to continuously measure the concentration of an analyte in the host; and a sensor electronics module physically connected to the continuous analyte sensor during use of the sensor. In one embodiment, the sensor electronics module comprises: an electronic device configured to process a data stream associated with the analyte concentration measured by the continuous analyte sensor to generate sensor information, the sensor information comprising, for example, raw sensor data, transformed sensor data, and / or any other sensor data. The sensor electronics module may also be configured to generate sensor information customized for a corresponding display device so that different display devices can receive different sensor information.

[0124] remind

[0125] In one embodiment, one or more reminders are associated with the sensor electronics module. For example, each reminder may include one or more reminder situations indicating when the corresponding reminder has been triggered. For example, a hypoglycemia reminder may include a reminder situation indicating a minimum glucose level. The reminder situation may also be based on transformed sensor data, such as trended data and / or sensor data from multiple different sensors (for example, the reminder may be based on sensor data from both a glucose sensor and a temperature sensor). For example, a hypoglycemia reminder may include reminder situations that indicate the minimum required trend in the host's blood glucose level that must exist before the reminder is triggered. The term "trend" as used herein generally refers to data that indicates a certain attribute of data acquired over time (such as, for example, data from the calibration or filtering of a continuous glucose sensor). The trend may indicate the amplitude, rate of change, acceleration, direction, etc. of data (such as sensor data including transformed or raw sensor data).

[0126] In one embodiment, each of the reminders is associated with one or more actions to be performed in response to the triggered reminder. The reminder action may, for example, include activating an alarm (such as displaying information on a display of the sensor electronics module or activating an audible or vibrating alarm coupled to the sensor electronics module) and / or transmitting data to one or more display devices external to the sensor electronics module. For any delivery action associated with the triggered reminder, one or more delivery options define the content and / or format of the data to be transmitted, the device to which the data will be transmitted, when the data will be transmitted, and / or the communication protocol used to deliver the data.

[0127] In one embodiment, multiple delivery actions (each with a corresponding delivery option) can be associated with a single reminder, such as to transmit displayable sensor information with different content and formatting to corresponding display devices in response to triggering a single reminder. For example, a mobile phone can receive a data packet including minimal displayable sensor information (which can be specifically formatted for display on the mobile phone), while a desktop computer can receive a data packet including most (or all) of the displayable sensor information generated by the sensor electronics module in response to triggering a common reminder. Advantageously, the sensor electronics module is not connected to a single display device, and in fact, it is configured to communicate with multiple different display devices directly, systematically, simultaneously (e.g., via broadcast), regularly, periodically, randomly, on demand, in response to a query, based on a reminder or alarm, etc.

[0128] In some embodiments, clinical risk reminders are provided, including reminder situations, which combine intelligent and dynamic estimation algorithms that estimate current or predicted dangers with greater accuracy, more timely when danger is about to occur, avoid false alarms and less disturbing patients. In general, clinical risk reminders include dynamic and intelligent estimation algorithms based on analyte values, change rates, accelerations, clinical risks, statistical probabilities, known physiological constraints and / or individual physiological patterns, thereby providing more appropriate, clinically safe and patient-friendly alarms. The co-pending U.S. patent publication No. 2007 / 0208246, which is incorporated herein by reference in its entirety, describes some systems and methods associated with clinical risk reminders (or alarms) described herein. In some embodiments, clinical risk reminders can be triggered for a predetermined time period to allow the user to pay attention to his / her condition. In addition, clinical risk reminders can be deactivated when leaving the clinical risk section to avoid repeated clinical reminders (e.g., visual, auditory or vibration) disturbing the patient when the patient's condition is improving. In some embodiments, dynamic and intelligent estimation determines the probability of a patient avoiding clinical risk based on analyte concentrations, change rates, and other aspects of dynamic and intelligent estimation algorithms. If there is a minimal probability of avoiding the clinical risk or no such probability, a clinical risk reminder will be triggered. However, if there is a possibility of avoiding the clinical risk, the system is configured to wait a predetermined amount of time and re-analyze the possibility of avoiding the clinical risk. In some embodiments, when there is a possibility of avoiding the clinical risk, the system is also configured to provide goals, treatment recommendations, or other information that can assist the patient in proactively avoiding the clinical risk.

[0129] In some embodiments, the sensor electronics module is configured to search for one or more display devices within the communication range of the sensor electronics module and wirelessly communicate sensor information (e.g., data packets that can display sensor information, one or more alert conditions, and / or other alarm information) to them. Thus, the display device is configured to display at least some of the sensor information and / or to alert the host (and / or caregiver), wherein the alarm mechanism is located on the display device.

[0130] In some embodiments, the sensor electronics module is configured to provide one or more different alarms via the sensor electronics module and / or via a transmission data packet indicating that one or more display devices should (e.g., sequentially and / or simultaneously) initiate an alarm. In some embodiments, the sensor electronics module determines which of the one or more alarms is triggered based on the triggered one or more reminders. For example, when a reminder indicating severe hypoglycemia is triggered, the sensor electronics module can perform multiple actions, such as activating an alarm on the sensor electronics module, transmitting a data packet indicating the activation of the alarm on the display to a small (key fob), and transmitting a data packet as a text message to a care provider. As an example, a text message can appear on a small (key fob) display, a cellular phone, a pager device, etc., including displayable sensor information indicating the host's condition (e.g., "severe hypoglycemia").

[0131] In some embodiments, the sensor electronics module is configured to wait a period of time for the host to respond to the triggered reminder (e.g., by pressing or selecting a snooze and / or shutoff function and / or button on the sensor electronics module and / or display device), after which additional reminders are triggered (e.g., in an escalating manner) until one or more reminders are responded to. In some embodiments, the sensor electronics module is configured to send a control signal (e.g., a stop signal) to a medical device (such as an insulin pump) associated with an alarm condition (e.g., hypoglycemia), wherein the stop reminder triggers cessation of insulin delivery via the pump.

[0132] In some embodiments, the sensor electronics module is configured to transmit alarm information directly, systematically, simultaneously (e.g., via broadcast), regularly, periodically, randomly, on demand, in response to a query (from a display device), based on a reminder or alarm, etc. In some embodiments, the system also includes a repeater, so that the wireless communication distance of the sensor electronics module can be increased, for example, to 10, 20, 30, 50, 75, 100, 150 or 200 meters or more, wherein the repeater is configured to repeat the wireless communication from the sensor electronics module to a display device located away from the sensor electronics module. The repeater can be useful for families with children suffering from diabetes. For example, allowing parents to carry or place a display device in a stationary position, such as in a large house where parents and children sleep at a distance.

[0133] Display Devices

[0134] In some embodiments, the sensor electronics module is configured to search and / or attempt wireless communication with a display device from a list of display devices. In some embodiments, the sensor electronics module is configured to search and / or attempt wireless communication with a list of display devices in a predetermined and / or programmable (e.g., hierarchical and / or escalating) order, for example, where a failed attempt to communicate with and / or alert with a first display device triggers an attempt to communicate with and / or alert with a second display device, and so on. In an example embodiment, the sensor electronics module is configured to sequentially search and attempt to alert a host or care provider using a list of display devices, such as 1) a default display device, 2) a key fob device, 3) a cellular phone (via auditory and / or visual methods, such as a text message to the host and / or care provider, a voice message to the host and / or care provider, and / or 911).

[0135] According to an embodiment, one or more display devices receiving data packets from the sensor electronics module are "virtual displays" in that they display the displayable sensor information received from the sensor electronics module without additional processing (e.g., look-ahead algorithm processing necessary for real-time display of the sensor information). In some embodiments, the displayable sensor information includes transformed sensor data that does not require display device processing before displaying the displayable sensor information. Some display devices may include software that includes display instructions configured to implement displaying the displayable sensor information thereon (software programming that includes instructions configured to display the displayable sensor information and optionally query the sensor electronics module to obtain the displayable sensor information). In some embodiments, the display device is programmed with display instructions at the manufacturer and may include security and / or authentication to avoid plagiarism of the display device. In some embodiments, the display device is configured to display the displayable sensor information via a downloadable program (e.g., a downloadable Java script via the Internet), so that any display device that supports downloading the program (e.g., any display device that supports Java applets) can therefore be configured to display the displayable sensor information (e.g., a mobile phone, PDA, PC, etc.).

[0136] In some embodiments, certain display devices may communicate directly wirelessly with the sensor electronics module, however intermediate network hardware, firmware and / or software may be included within the direct wireless communication. In some embodiments, a repeater (e.g., a Bluetooth repeater) may be used to retransmit the transmitted displayable sensor information to a location further away than the current range of the telemetry module of the sensor electronics module, wherein the repeater enables direct wireless communication when substantial processing of the displayable sensor information does not occur. In some embodiments, a receiver (e.g., a Bluetooth receiver) may be used to retransmit the transmitted displayable sensor information to a TV screen, possibly in a different format (e.g., as a text message), wherein the receiver enables direct wireless communication when substantial processing of the sensor information does not occur. In one embodiment, the sensor electronics module directly wirelessly transmits the displayable sensor information to one or more display devices, such that the displayable sensor information transmitted from the sensor electronics module is received by the display device without intermediate processing of the displayable sensor information.

[0137] In one embodiment, one or more display devices include a built-in authentication mechanism, wherein authentication is required for communication between the sensor electronics module and the display device. In some embodiments, to authenticate data communications between the sensor electronics module and the display device, a challenge-response protocol (such as password authentication) is provided, wherein a challenge is a request for a password, and a valid response is a correct password, so that a user and / or manufacturer can pair the sensor electronics module with the display device via the password. However, any known authentication system or method useful for telemetry devices may be used with the preferred embodiment.

[0138] In some embodiments, one or more display devices are configured to query the sensor electronics module for displayable sensor information, wherein the display device acts as a master device that requests sensor information from the sensor electronics module (e.g., a slave device) on demand (e.g., in response to a query). In some embodiments, the sensor electronics module is configured for periodic, systematic, regular, and / or periodic transmission of sensor information to one or more display devices (e.g., every 1, 2, 5, or 10 minutes or more). In some embodiments, the sensor electronics module is configured to transmit a data packet associated with a triggered reminder (e.g., triggered by one or more reminder situations). However, any combination of the data transmission states described above can be implemented using any combination of paired sensor electronics modules and display devices. For example, one or more display devices can be configured to query the sensor electronics module database and to receive alarm information triggered by satisfying one or more alarm situations. In addition, the sensor electronics module can be configured to periodically transmit sensor information to one or more display devices (display devices that are the same or different from the display devices described in the previous example), wherein the system may include display devices that work differently in terms of how they obtain sensor information.

[0139] In some embodiments, as described in more detail elsewhere herein, the display device is configured to query a data storage device memory in the sensor electronics module for certain types of data content, including directly querying a database in the memory of the sensor electronics module and / or a request for a configured or configurable data content package from the database; that is, the data stored in the sensor electronics module is configurable, queryable, predetermined and / or pre-packaged based on the display device with which the sensor electronics module communicates. In some additional or alternative embodiments, the sensor electronics module generates displayable sensor information based on its knowledge of which display device will receive a particular transmission. In addition, some display devices are capable of obtaining calibration information and wirelessly transmitting the calibration information to the sensor electronics module, such as by manually entering the calibration information, automatically delivering the calibration information, and / or an integrated reference analyte monitor incorporated into the display device. U.S. Patent Publication Nos. 2006 / 0222566, 2007 / 0203966, 2007 / 0208245, and 2005 / 0154271, all of which are incorporated herein by reference in their entirety, describe systems and methods for providing an integrated reference analyte monitor incorporated into a display device and / or other calibration methods that may be implemented with the preferred embodiments.

[0140] Generally speaking, multiple display devices (e.g., small (key fob) display devices, larger (handheld) display devices, mobile phones, reference analyte monitors, drug delivery devices, medical devices, and personal computers) are configured to communicate wirelessly with a sensor electronics module, wherein one or more of the display devices are configured to display at least some of the displayable sensor information wirelessly communicated from the sensor electronics module, wherein the displayable sensor information includes, for example, sensor data (e.g., raw data) and / or transformed sensor data (e.g., analyte concentration values), rate of change information, trend information, alert information, sensor diagnostic information, and / or calibration information.

[0141] Small (key pendant) display device

[0142] In some embodiments, one of the plurality of display devices is a small (e.g., key fob) display device 14 (eg, a key fob) configured to display at least some of the sensor information (e.g., analyte concentration values ​​and trend arrows). Figure 1 ). Generally, a key fob device is a small hardware device with a built-in authentication mechanism that is sized to fit on a key chain. However, the functionality described herein with reference to a key fob device 14 may be configured to any small display device 14, including a wristband, a tag, a belt, a necklace, a pendant, a piece of jewelry, a patch, a pager, an identification (ID) card, etc., and the phrases "small display device" and / or "key fob device" herein include all such small display devices.

[0143] In general, the key fob device 14 includes electronics configured to receive and display displayable sensor information (and optionally configured to query the sensor electronics module for displayable sensor information). In one embodiment, the electronics include RAM and program storage memory configured to display sensor data received from the sensor electronics module. In some embodiments, the key fob device 14 includes an alarm configured to alert the host of a triggered (e.g., audio, visual, and / or vibration) reminder. In some embodiments, the key fob device 14 includes a user interface, such as an LCD 602 ​​and one or more buttons 604, that allows a user to view data (e.g., values ​​and / or arrows), cycle through one or more screens, select or define one or more user parameters, respond to reminders (e.g., silence, snooze, shut down), etc.

[0144] In some embodiments, the key fob display device has memory (such as, for example, in a gigabyte memory stick or thumb drive) to store sensors, medications (e.g., insulin), and other medical information, thereby implementing a memory stick type function that allows data transfer from the sensor electronics module to another device (e.g., a PC) and / or as a data backup location for the sensor electronics module memory (e.g., data storage device memory). In some embodiments, the key fob display device is configured to be automatically readable by a network system upon entry to a hospital or other medical complex.

[0145] In some embodiments, the key fob display device includes a physical connector (such as USB port 606) for enabling connection to a port (e.g., USB) on a computer, thereby enabling the key fob to operate as a data download device (e.g., from a sensor electronics module to a PC), a telemetry connector (e.g., a Bluetooth adapter / connector for a PC), and / or to enable configurable settings on the key fob device (e.g., via software on a PC that allows configurable parameters such as numbers, arrows, trends, alarms, fonts, etc.). In some embodiments, user parameters associated with the small (key fob) display device can be programmed into (and / or modified by) a display device (e.g., a personal computer, a personal digital assistant, etc.). In one embodiment, the user parameters include contact information, reminder / alarm settings (e.g., thresholds, sounds, volume, etc.), calibration information, font size, display preferences, defaults (e.g., screens), etc. Alternatively, the small (key fob) display device can be configured for direct programming of user parameters. In some embodiments, where the small (key fob) display device includes a telemetry module (such as Bluetooth) and a USB connector (etc.), the small (key fob) display device also works, for example, as a telemetry adapter (e.g., a Bluetooth adapter) to enable direct wireless communication between the sensor electronics module and a PC, where the PC does not include an appropriate telemetry adapter therein.

[0146] Large (handheld) display devices

[0147] In some embodiments, one of the multiple display devices is a handheld display device 16 ( Figure 1), the sensor information includes analyte concentration and a graphical representation of analyte concentration over time. Generally speaking, the handheld display device includes a display 608 large enough to display a graphical representation 612 of sensor data (such as sensor data for the first 1, 3, 5, 6, 9, 12, 18 or 24 hours) within a time period. In some embodiments, the handheld device 16 is configured to display trend graphs or other graphical representations, numerical values, arrows and / or alarms to the host. The U.S. Patent Publication No. 2005 / 0203360, which is incorporated herein in its entirety by reference, describes and illustrates some examples of displaying data on a handheld display device. Although FIG. 6 illustrates an embodiment of a handheld display device, the handheld device can be any single-application device or multi-application device, such as a mobile phone, a palmtop computer, a PDA, a portable media player (such as an iPod, an MP3 player), a blood glucose meter, an insulin pump, etc.

[0148] In some embodiments, the mobile phone (or PDA) is configured to display (as described above) and / or forward the sensor information to the host and / or the host's care provider, such as via voice or text message. In some embodiments, the mobile phone also includes an alarm that is configured to alert the host of a triggered reminder, such as in response to receiving a data packet indicating a triggered reminder. According to an embodiment, the data packet may include displayable sensor information (such as an on-screen message, a text message, and / or a pre-generated graphical representation of sensor data and / or transformed sensor data) and an indication of an alarm (such as an audible alarm or a vibration alarm) that the mobile phone should activate.

[0149] In some embodiments, one of the display devices is a drug delivery device configured to display sensor information, such as an insulin pump and / or insulin pen. In some embodiments, the sensor electronics module is configured to wirelessly communicate sensor diagnostic information to the drug delivery device so that the drug delivery device can consider (include in its calculations / algorithms) the quality, reliability and / or accuracy of the sensor information for the closed-loop and / or semi-closed-loop system described more specifically in the U.S. Patent Publication No. 2005 / 0192557, which is incorporated herein by reference in its entirety. In some alternative embodiments, the sensor electronics module is configured to wirelessly communicate with a drug delivery device that does not include a display, so as to implement a closed-loop and / or semi-closed-loop system as described above.

[0150] In some embodiments, one of the display devices is a drug delivery device is a reference analyte monitor, such as a blood glucose meter, configured to measure a reference analyte value correlated to an analyte concentration in a biological sample from the host.

[0151] Personal computer display device

[0152] In some embodiments, one of the display devices is a personal computer (PC) 20 ( Figure 1 ). Preferably, PC 24 has software installed, wherein the software enables display of historical sensor information and / or performs data analysis (backtracking) of historical sensor information. In some embodiments, a hardware device (not shown) may be provided, wherein the hardware device (e.g., a dongle / adapter) is configured for insertion into a port on the PC to enable wireless communication between the sensor electronics module and the PC. In some embodiments, PC 24 is configured to set / or modify configurable parameters of sensor electronics module 12 and / or key fob 14 as described in more detail elsewhere herein.

[0153] Other display devices

[0154] In some embodiments, one of the display devices is an on-skin display device that is detachable from, releasably attachable to, and / or dockable to the sensor housing (mounting unit, sensor cover, etc.). In some embodiments, releasing the on-skin display device turns off the sensor; in other embodiments, the sensor housing includes sufficient sensor electronics to maintain sensor operation even when the on-skin display device is released from the sensor housing.

[0155] In some embodiments, one of the display devices is a secondary device, such as a heart rate monitor, a pedometer, a temperature sensor, a car initialization device (e.g., configured to allow or not allow the car to start and / or drive in response to at least some of the sensor information wirelessly communicated from the sensor electronics module (e.g., a glucose value above a predetermined threshold)). In some alternative embodiments, one of the display devices is designed for an alternative function device (e.g., a caller ID device), wherein the system is configured to communicate with the alternative device and / or translate the displayable sensor information into a customized protocol of the alternative device so that the displayable sensor information can be displayed on the alternative function device (the display of the caller ID device).

[0156] Example Configuration

[0157] Figure 1 is a diagram illustrating one embodiment of a continuous analyte sensor system 8 including a sensor electronics module 12. Figure 1 In an embodiment of the present invention, the system includes a continuous analyte sensor 10 physically connected to a sensor electronics module 12 that is in direct wireless communication with a plurality of different display devices 14 , 16 , 18 , and / or 20 .

[0158] In one embodiment, the sensor electronics module 12 includes an electronic circuit device associated with measuring and processing continuous analyte sensor data, which includes a forward-looking algorithm associated with processing and calibrating sensor data. The sensor electronics module 12 can be physically connected to the continuous analyte sensor 10 and can be integrated with the continuous analyte sensor 10 (non-releasably attached to the continuous analyte sensor 10) or releasably attached to the continuous analyte sensor 10. The sensor electronics module 12 may include hardware, firmware and / or software that allows the measurement of analyte levels via a glucose sensor such as an analyte sensor. For example, the sensor electronics module 12 may include a voltage regulator, a power source for providing power to the sensor, other components useful for signal processing and data storage, and a telemetry module for transmitting data from the sensor electronics module to one or more display devices. The electronic device can be adhered to a printed circuit board (PCB) and the like and can be in a variety of forms. For example, the electronic device can be in the form of an integrated circuit (IC), a microcontroller and / or a processor such as an application specific integrated circuit (ASIC). The sensor electronics module 12 includes a sensor electronics device configured to process sensor information (such as sensor data) and generate transformed sensor data and displayable sensor information. Examples of systems and methods for processing sensor analyte data are described in more detail herein and in U.S. Pat. Nos. 7,310,544 and 6,931,327, and U.S. Patent Publication Nos. 2005 / 0043598, 2007 / 0032706, 2007 / 0016381, 2008 / 0033254, 2005 / 0203360, 2005 / 0154271, 2005 / 0192557, 2006 / 0222566, 2007 / 0203966, and 2007 / 0208245, which are incorporated herein by reference in their entireties.

[0159] Refer again Figure 1 , a plurality of display devices (14, 16, 18 and / or 20) are configured to display (and / or alert) displayable sensor information that has been transmitted by the sensor electronics module 12 (e.g., in a customized data packet transmitted to them based on the display devices' respective preferences). For example, the display devices are configured to display the displayable sensor information as it is communicated from the sensor electronics module (e.g., in a data packet transmitted to the respective display device) without any additional look-ahead processing required for calibration and real-time display of the sensor data.

[0160] exist Figure 1In some embodiments, the plurality of display devices include a small (key fob) display device 14, such as a wristwatch, a belt, a necklace, a pendant, a piece of jewelry, a patch, a pager, a key fob, a plastic card (e.g., a credit card), an identification (ID) card, etc., wherein the small display device includes a relatively small display (e.g., smaller than the large display device) and is configured to display certain types of displayable sensor information (e.g., numerical values ​​and arrows in some embodiments). In some embodiments, one of the plurality of display devices is a large (handheld) display device 16, such as a handheld receiver device, a palmtop computer, etc., wherein the large display device includes a relatively larger display (e.g., larger than the small display device) and is configured to display a graphical representation of continuous sensor data (e.g., including current and historical data). Other display devices may include other handheld devices (e.g., a cellular phone or PDA 18), an insulin delivery device, a blood glucose meter, and / or a desktop or laptop computer 24.

[0161] Since different display devices provide different user interfaces, the content of the data packet (e.g., the amount, format and / or type of data to be displayed, alarms, etc.) can be customized (e.g., programmed differently by the manufacturer and / or end user) for each specific display device. Figure 1 In an embodiment, multiple different display devices communicate directly and wirelessly with a sensor electronics module (such as, for example, an on-skin sensor electronics module 12 physically connected to the continuous analyte sensor 10) during a sensor session to implement multiple different types and / or levels of displays and / or functionality associated with displayable sensor information as described in more detail elsewhere herein.

[0162] Continuous Sensor

[0163] In some embodiments, the glucose sensor comprises a continuous sensor, such as a subcutaneous, transdermal (e.g., percutaneous) or intravascular device. In some embodiments, the device can analyze multiple intermittent blood samplings. The glucose sensor can use any glucose measurement method, including enzyme, chemical, physical, electrochemical, spectrophotometric, polarimeter, calorimeter, iontophoresis, radiation, immunochemical, etc.

[0164] The glucose sensor may use any known method for providing a data stream indicative of the glucose concentration in the host, including invasive, minimally invasive, and non-invasive sensing techniques (e.g., fluorescence monitoring). The data stream is typically a raw data signal that is converted into a calibrated and / or filtered data stream that is used to provide useful glucose values ​​to a user, such as a patient or a caregiver (e.g., a patient, family member, guardian, teacher, physician, nurse, or any other individual interested in the health of the host).

[0165] The glucose sensor can be any device capable of measuring glucose concentration. An example embodiment utilizing an implantable glucose sensor is described below. However, it should be understood that the devices and methods described herein can be applied to any device capable of detecting glucose concentration and providing an output signal representative of the glucose concentration.

[0166] In one embodiment, the analyte sensor is an implantable glucose sensor such as described in US Pat. No. 6,001,067 and US Pat. No. US-2005-0027463-A1. In another embodiment, the analyte sensor is a transcutaneous glucose sensor such as described in US Pat. No. US-2006-0020187-A1. In still other embodiments, the sensor is configured for implantation in a host vessel or in vitro, such as described in U.S. Patent Publication No. US-2007-0027385-A1, co-pending U.S. Patent Publication No. US-2008-0119703-A1 filed on October 4, 2006, co-pending U.S. Patent Publication No. US-2008-0108942-A1 filed on March 26, 2007, and co-pending U.S. Patent Application No. US-2007-0197890-A1 filed on February 14, 2007. In an alternative embodiment, the continuous glucose sensor includes, for example, a transcutaneous sensor such as described in U.S. Patent No. 6,565,509 to Say et al. In another alternative embodiment, the continuous glucose sensor includes, for example, a subcutaneous sensor such as described in U.S. Patent No. 6,579,690 to Bonnecaze et al. or U.S. Patent No. 6,484,046 to Say et al. In another alternative embodiment, the continuous glucose sensor comprises, for example, a refillable subcutaneous sensor such as described in U.S. Pat. No. 6,512,939 to Colvin et al. In another alternative embodiment, the continuous glucose sensor comprises, for example, an intravascular sensor such as described in U.S. Pat. No. 6,477,395 to Schulman et al. In another alternative embodiment, the continuous glucose sensor comprises, for example, an intravascular sensor such as described in U.S. Pat. No. 6,424,847 to Mastrototaro et al.

[0167] Figure 2A and 2B2 is a transmissive and side view of a sensor system in one embodiment, shown in its working position, the sensor system including an assembly unit 214 and a sensor electronics module 12 attached to the assembly unit, including an assembly unit and a sensor electronics module used in pairs. In some embodiments, the assembly unit 214, also referred to as a shell or sensor housing, includes a base 234 adapted to be fastened to the skin of the host. The base can be formed of a variety of hard or soft materials and can include a low profile for minimizing the protrusion of the device from the host during use. In some embodiments, the base 234 is at least partially formed of a flexible material, which is considered to provide many advantages over conventional transcutaneous sensors, which unfortunately may suffer from motion-related unnatural components (artifacts) associated with the movement of the host when the host uses the device. The assembly unit 214 and / or the sensor electronics module 12 can be located above the sensor insertion site to protect the site and / or provide a minimum footprint (surface area utilization of the host skin).

[0168] In some embodiments, a detachable connection between the mounting unit 214 and the sensor electronics module 12 is provided, which enables improved manufacturability, i.e., the relatively inexpensive mounting unit 214 can be discarded when it is replaced after the useful life of the sensor system, while the relatively more expensive sensor electronics module 12 can be reused in multiple sensor systems. In some embodiments, the sensor electronics module 12 is configured with signal processing (programming), which is configured, for example, for filtering, calibration, and / or other algorithms for calibrating and / or displaying sensor information. However, an integral (non-detachable) sensor electronics module may be configured.

[0169] In some embodiments, contact 238 is mounted on or in a subassembly, hereinafter referred to as contact subassembly 236, which is configured to mate within base 234 of mounting unit 214 and hinge 248, which allows contact subassembly 236 to rotate between a first position (for insertion) and a second position (for use) relative to mounting unit 214. The term "hinge" as used herein is a broad term and is used in its ordinary sense, including but not limited to referring to any of a variety of rotational, articulated and / or hinge mechanisms (such as bonded hinges, sliding joints, etc.); the term hinge does not necessarily mean a fulcrum or fixed point around which the connection occurs. In some embodiments, contact 238 is formed of a conductive elastic material (such as a carbon black elastomer) through which sensor 10 extends.

[0170] In certain embodiments, the mounting unit 214 has an adhesive pad 208 disposed on a back surface of the mounting unit and includes a releasable backing layer. Thus, the backing layer is removed and the base portion 234 of the mounting unit is pressed against the host's skin to adhere the mounting unit 214 to the host's skin. Additionally or alternatively, an adhesive pad may be placed over some or all of the components of the sensor system after sensor insertion is complete to ensure adhesion, and optionally to ensure an airtight or watertight seal around the exit site (or sensor insertion site) of the wound (not shown). An appropriate adhesive pad may be selected and designed to stretch, elongate, conform to and / or inflate the area (e.g., the host's skin). Reference is made to U.S. Patent No. 7,310,544, which is incorporated herein by reference in its entirety, for a more detailed description of the mounting unit 214. Figure 2A and 2B Described Embodiments. Configurations and arrangements may provide for water-resistant, waterproof, and / or hermetically sealed properties associated with the mounting unit / sensor electronics module embodiments described herein.

[0171] Various methods and apparatus suitable for use in conjunction with aspects of some embodiments are disclosed in U.S. Patent Publication No. US-2009-0240120-A1, which is incorporated herein by reference in its entirety.

[0172] Using data communication protocol

[0173] Figure 3 1 is an example block diagram illustrating various elements of one embodiment of a continuous analyte sensor system 8 and display devices 14, 16, 18, 20. The sensor system 8 may include a sensor 312 (also shown in FIG. 1 ) coupled to a sensor measurement circuit 310 for processing and managing sensor data. Figure 1 The sensor measurement circuit 310 may be coupled to a processor 314 ( Figure 1 In some embodiments, sensor 314 may perform some or all of the functions of sensor measurement circuit 310 for obtaining and processing sensor measurements from sensor 312. The processor may also be coupled to transceiver 316 ( Figure 1 The transceiver is used to send sensor data and receive requests and commands from external devices (such as display devices 14, 16, 18, 20) used to display or otherwise provide sensor data to a user. The sensor system 8 may also include a memory 318 ( Figure 1 12) and the real-time clock 320 ( Figure 1 Part of item 12).

[0174] Wireless communication protocols can be used to transmit and receive data between the sensor system 8 and the display device 14, 16, 18, 20. The wireless protocol used can be designed for use in a wireless sensor network that is optimized for periodic small data transmissions (if necessary, at low rates) to and from multiple devices in close proximity (e.g., a personal area network (PAN)). For example, a protocol can be optimized for periodic data transmission, where a transceiver can be configured to transmit data for short intervals and then enter a low power mode for long intervals. The protocol can have low overhead requirements (e.g., by reducing header overhead) for both normal data transmission and for initially setting up a communication channel to reduce power consumption. In some embodiments, a burst broadcast scheme (e.g., one-way communication) can be used. This can eliminate the overhead required for confirmation signals and allow periodic transmissions that consume very little power.

[0175] The protocol can also be configured to establish a communication channel with multiple devices when implementing the interference avoidance scheme. In some embodiments, the protocol can utilize an adaptive isochronous network topology, which defines various time slots and frequency bands for communicating with several devices. The protocol can therefore modify the transmission window and frequency in response to interference and support communicating with multiple devices. Thus, the wireless protocol can use a scheme based on time division and frequency division multiplexing (TDMA). The wireless protocol can also use direct sequence spread spectrum (DSSS) and frequency hopping spread spectrum schemes. Various network topologies can be used to support low-power wireless communications, such as peer-to-peer, star, tree or mesh network topologies. The wireless protocol can operate in various frequency bands (such as the open ISM band of 2.4 GHz). In addition, in order to reduce power usage, the wireless protocol can adaptively configure the data rate according to power consumption.

[0176] The display device 14, 16, 18, 20 may be used to alert and provide sensor information to the user and may include a processor 330 for processing and managing sensor data. The display device 14, 16, 18, 20 may include a display 332, a memory 334, and a real-time clock 336 for displaying, storing, and tracking sensor data, respectively. The display device 14, 16, 18, 20 may also include a transceiver 338 for receiving sensor data and for sending requests, instructions, and data to the sensor system 8. The transceiver 338 may also employ a communication protocol.

[0177] In some embodiments, when using standardized communication protocols, commercially available transceiver circuits may be utilized that incorporate processing circuitry for handling low-level data communication functions, such as managing data encoding, transmission frequency, handshake protocols, etc. In these embodiments, the processors 314, 330 need not manage these activities, but actually provide the desired data values ​​for transmission, and manage higher-level functions, such as powering up or down, setting the rate at which messages are transmitted, etc. Instructions and data values ​​for performing these higher-level functions may be provided to the transceiver circuits via a data bus and transmission protocol established by the manufacturer of the transceiver circuits 316.

[0178] The components of the analyte sensor system 8 may need to be replaced periodically. For example, the analyte sensor system 8 may include an implantable sensor 312 that can be attached to a sensor electronic device module, and the sensor electronic device module includes a sensor measurement circuit 310, a processor 314, a memory 318 and a transceiver 316 and a battery (not shown). The sensor 312 may need to be replaced periodically (for example, every 7-30 days). The sensor electronic device module can be configured to be powered and active for much longer than the sensor 312 (for example, for six months or more) until the battery needs to be replaced. Replacing these components may be difficult and require trained personnel assistance. Reducing the need to replace such components (especially batteries) significantly improves the convenience of the analyte sensor system 8 for users. In some embodiments, the sensor session as defined above can correspond to the life of the sensor 312 (for example, 7-30 days). When the sensor electronic device module is used for the first time (or once the battery has been replaced in some cases, it is reactivated), it can be connected to the sensor 312 and a sensor session can be established. As will be further described below, there may be a process for initially establishing communication between the display device 14, 16, 18, 20 and the sensor electronics module when it is first used or reactivated (e.g., to replace the battery). Once the display device 14, 16, 18, 20 and the sensor electronics module have established communication, the display device 14, 16, 18, 20 and the sensor electronics module may communicate periodically and / or continuously over the life of the number of sensors 312 until, for example, the battery needs to be replaced. Each time a sensor 312 is replaced, a new sensor session may be established. A new sensor session may be initiated by a process accomplished using the display device 14, 16, 18, 20, and notification of a new sensor may trigger the process via communication between the sensor electronics module and the display device 14, 16, 18, 20 that may persist across the sensor session.

[0179] The analyte sensor system 8 collects analyte data from the sensor 312, which it periodically sends to the display device 14, 16, 18, 20. Data points are collected and transmitted over the life of the sensor (e.g., 1-30 days or more). It may be necessary to transmit new measurements frequently enough to adequately monitor the glucose level. Instead of having the transmission and receiving circuitry of each of the sensor system 8 and the display device 12, 16, 18, 20 communicate continuously, the analyte sensor system 8 and the display device 14, 16, 18, 20 can regularly and periodically establish a communication channel between them. Therefore, the sensor system 8 can communicate with the display device 14, 16, 18, 20 (e.g., a handheld computing device) via wireless transmission at predetermined time intervals. The duration of the predetermined time interval can be selected to be long enough so that the sensor system 8 does not consume too much power by transmitting data more frequently than necessary, and is frequent enough to provide substantially real-time sensor information (e.g., measured glucose values) to the display device 14, 16, 18, 20 for output (e.g., display) to the user. Although the predetermined time interval is every five minutes in one embodiment, it is understood that this time interval may be varied to any desired length of time.

[0180] Figure 4A 1 is a flow chart of an example communication between the analyte sensor system 8 and the display devices 14, 16, 18, 20 for communicating glucose measurement values. Data transmission may be performed at an update interval T that may correspond to a period of time (e.g., five minutes) for obtaining and sending newly measured glucose values. update The separation occurs periodically. Between these data transfer processes, the transceiver 316 of the analyte sensor system 8 may be powered down or in a sleep mode to conserve battery life. Thus, the analyte sensor system 8 may therefore update the data every update interval T. update The communication channel with the display devices 14, 16, 18, 20 is established once. The communication channel can be established at an update interval T update Transmission window T window Appear during.

[0181] To establish a communication channel, the analyte sensor system 8 may update the analyte sensor system 8 at an update interval T update Transmission window T windowDuring the period of sending one or more message beacons. Each message beacon can be regarded as inviting display devices 14,16,18,20 to establish a communication channel with sensor system 8. As will be further described below, beacons can include data including challenge values ​​for authenticating display devices 14,16,18,20. During the initial system establishment, display devices 14,16,18,20 can continuously listen until receiving such message beacons. When successfully receiving beacons, display devices 14,16,18,20 can confirm reception to establish communication between devices. As will be further described below, in response to beacons, display devices 14,16,18,20 can send messages requesting measurement together with calculated values ​​for authentication. Once authenticated, analyte sensor system 8 and display devices 14,16,18,20 can exchange information to determine how to exchange data (e.g., specific frequency, time slot assignment, etc.). When the desired data communication is complete, the channel can be closed and the transceiver 316 of the analyte sensor system 8 (and possibly the transceiver 338 of the display device 14, 16, 18, 20) can be powered down. The entire data transmission window interval T for providing data to one or more display devices 14, 16, 18, 20 is window It can be the update interval T update For example, T update It can be five minutes, and the data transmission window interval T window It can be thirty seconds. In this way, it can be only for five minutes T update The transceiver 316 of the analyte sensor system 8 is powered for substantially 30 seconds at intervals. This can significantly reduce power consumption. In some cases, the transceiver 316 is not completely powered down, but enters a low power mode when not transmitting. update After the interval has elapsed, the transceivers 316, 338 may be synchronized to be powered up again substantially simultaneously and used as described above. Figure 4A The same process shown in for exchanging any new data is used to establish a new communication channel. This process can continue to establish new communication channels at predetermined intervals.

[0182] To account for some loss of synchronization between the two devices in between transmissions, the analyte sensor system 8 can be configured to send a series of message beacons 402 in a time window around the scheduled transmission time (e.g., 8 message beacons per second in 4 seconds). Any one of the message beacons can be used to initiate the establishment of a new communication channel when the display device 14, 16, 18, 20 receives it. After communicating with a device during the transmission window, the analyte sensor system 8 can send out more message beacons 404. These beacons can be received and used to communicate within the transmission window T. windowDuring this time, other communication channels with other devices (e.g., other display devices) are established. However, in some embodiments, if it is known that the analyte sensor system 8 communicates with only a single display device, the transmission window T may be terminated at the same time as the communication channel with the display device is closed. window .

[0183] Figure 4B is a timing diagram of an example sequence for establishing a communication channel between the analyte sensor system 8 and the display devices 14, 16, 18, 20. The display device 14, 16, 18, 20 may initially "wake up" its transceiver 316 and wait to receive a beacon from the analyte sensor system 8. Once the analyte sensor system 8 begins sending beacons, the display device 14, 16, 18, 20 may require one, two, or more beacons to receive the beacons and respond with a request. Once the beacon is received and the request is sent, data may then be sent and / or received as shown in the shaded time slots. Once the analyte sensor system 8 and the display device 14, 16, 18, 20 determine that all requested data has been transmitted to the respective devices or the transmission window time has expired, the channel may then be closed. At the new T update When the interval begins, the process repeats.

[0184] New communication channels are continuously reestablished to take into account the update Partially or completely powering down the transceiver 316 during the transmission window T can provide significant power savings and can allow the sensor electronics module 12 to continue to operate for six months or more without battery replacement. window By blindly transmitting glucose data points during the communication, a communication channel can be established so that only the desired display devices 14, 16, 18, 20 can receive the glucose information. This can prevent unauthorized use and interception of glucose measurements. In addition, by establishing a secure two-way communication channel, requests for specific glucose measurements or communication of calibration or configuration information can be transmitted between the sensor system 8 and the display devices 14, 16, 18, 20 on an as-needed / requested basis.

[0185] In addition, in some embodiments, the communication window does not need to be updated every update interval T update Alternatively, the communication window may be opened every second, third or fourth update interval T, for example. update Open, so that the communication between the sensor system 8 and the display devices 14, 16, 18, 20 is faster than every update interval T update This can further reduce power consumption. Therefore, a window frequency variable F indicating the frequency at which the communication window is opened can be used. window .

[0186] In some embodiments, the update interval Tupdate , transmission window T window and / or window frequency F window Can be mutable. update , T window and / or F window It may be configurable by a user (eg, by entering a value for the variable using a user interface of the display device 14, 16, 18, 20) and / or automatically varied by the sensor system 8 or the display device 14, 16, 18, 20 based on one or more criteria. The criteria may include: (i) monitored battery power of the sensor system 8, (ii) a currently measured, previously measured, and / or predicted glucose concentration that meets or exceeds a predetermined threshold, (iii) a trend in the host's glucose concentration based on the currently measured, previously measured, and / or predicted glucose concentration, (iv) a rate of change in the host's glucose concentration based on the currently measured, previously measured, and / or predicted glucose concentration that meets or exceeds a predetermined threshold, (v) whether the host is determined to be in hyperglycemia or approaching hyperglycemia based on the currently measured, previously measured, and / or predicted glucose concentration, (vi) whether the host is determined to be in hypoglycemia or approaching hypoglycemia based on the currently measured, previously measured, and / or predicted glucose concentration, (vii) a user-entered activity of the host (e.g., exercising or sleeping), (viii) a time since a sensor session has begun (e.g., when using a new sensor 10), (ix) one or more errors detected by the sensor system 8 or display device 14, 16, 18, 20, and (x) the type of display device.

[0187] T update , T window and / or F window and other configuration items described herein may form part of a communication protocol profile that may be stored on any device (such as the sensor system 10 and display devices 14, 16, 18, 20) that implements the basic communication protocol to allow the protocol to be customized for receiving glucose measurements.

[0188] Figure 5 is a flow chart of an example method for sending glucose measurements from the analyte sensor system 8 to the display devices 14, 16, 18, 20. updateAt a predetermined time in block 504, the analyte sensor system 8 can activate the transceiver 316 as shown in block 502. This can include powering the transceiver 316 or waking up the transceiver 316 from a low power mode / state (such as a sleep mode). In block 504, the transceiver 316 can open and establish an authenticated two-way communication channel between the analyte sensor system 8 and the display device 14, 16, 18, 20. If the channel is established, in block 506, the analyte sensor system 8 and the display device 14, 16, 18, 20 can automatically (e.g., the device determines a trigger event for transmitting specific information) or in response to a request received from other devices to transmit information between them. Such information can include one or more glucose measurements, calibration information, reminder settings, communication synchronization information, etc. Once the transmission is completed and the data requested by the display device 14, 16, 18, 20 and the sensor system 10 is sent, the analyte sensor system 8 can close the communication channel. In block 510, the analyte sensor system 8 may deactivate the transceiver 316, such as by powering down the transceiver or placing it in a low power mode. The operations in blocks 504 to 508 may be repeated with the additional display device until the transmission window T window The analyte sensor system 8 may then wait for the next transmission window T as shown in block 512 before continuously repeating the process for the duration of the sensor session (eg, corresponding to the life of a non-durable sensor). window Open and collect glucose measurements during this period. In each transmission window T window In between, new analyte sensor measurements may be obtained and stored for transmission.

[0189] Sensor electronics unit window conversion

[0190] In some embodiments, the sensor electronics module 12 may be placed in a mode where transmission windows occur more frequently than during normal use. This may be useful for pairing new devices with the sensor electronics module to, for example, speed up pairing between devices.

[0191] In some implementations, when the sensor electronics module 12 is used for the first time, the display device with which the user wants to pair the sensor electronics module has no information about when the sensor electronics module will next open the transmission window T. window In addition, the window frequency F window It can be low, such as a window only opens every 5 minutes. As a result, if the display device is constantly listening for beacons from the sensor electronics module, the display device may not be paired with the sensor electronics module for nearly five minutes. This may result in a lengthy pairing process that consumes valuable power.

[0192] Thus, in some implementations, the sensor electronics module 12 may be switched from a first state (manually or automatically) to a second state to facilitate pairing, wherein the window frequency F window The sensor electronics module 12 may switch back to the first state or to a third state having a window frequency different from the first state and the second state after pairing. The sensor electronics module may switch back to the first state or the third state automatically in response to the sensor electronics module determining a successful pairing between the two devices, or may be manually switched back to the first state or the third state by a user via an external switch or user input using an electronic device user interface. In one implementation, the first state corresponds to a state in which the window frequency F is greater than the window frequency F in the second state. window The storage mode is 0 (i.e., not entering the transmission window to save power), and the third state corresponds to the window frequency F window A normal operating state where the window frequency F is greater than zero but less than the second state. As a non-limiting example, during the second state, the window frequency F window It can be 30 seconds, and the window frequency F during the third state is window It can be 5 minutes.

[0193] The following is an example of the switching window frequency F window In a non-limiting example implementation for power conservation and to facilitate pairing. As discussed above, the sensor electronics module 12 may be configured for, for example, Figure 2A and 2B 1 and 2. The sensor electronics module 12 may be manufactured and then stored in a container (such as a cartridge) prior to use. To conserve power, the sensor electronics module 12 may be placed in a low power state while in the container and then switched to a paired state after the sensor electronics unit is removed from the storage container.

[0194] The sensor electronics module may be maintained in a low power state by using an external magnet and a reed switch or a Hall effect switch within the sensor electronics module 12. The use of an external magnet to maintain the sensor electronics module in a low power mode is described in more detail in U.S. Patent Application No. 13 / 247,856 filed on September 28, 2011, which is incorporated herein by reference in its entirety. The magnet may be placed next to the sensor electronics module 12 during manufacturing, next to the sensor electronics module 12 in a container, to maintain the sensor electronics module in a low power state while in the container. When it is desired to use the sensor electronics module 12, the sensor electronics module 12 may be removed from the container and the magnet removed from the vicinity of the sensor electronics module to switch the sensor electronics module to a paired state. A reed switch, a Hall effect switch, etc. may reside in the sensor electronics module to, for example, trigger switching the sensor electronics module from a low power state to a paired state.

[0195] Thus, the sensor electronics module 12 may be in a low power state while in the storage device, switch to a pairing state when removed from the storage device (e.g., by removing a magnet), and then switch to a normal operating state once the sensor electronics module 12 is paired with the display device. The low power state may include keeping the transceiver powered off or otherwise in a low power state in which beacons are not transmitted. The pairing state may include a high window frequency F window , such as every 30 seconds, wherein one or more beacons are transmitted during each window. The normal operating state may include a relatively low window frequency F for opening a communication channel with one or more display devices to exchange information including sensor data values. window , for example every 5 minutes.

[0196] Additionally, in some implementations of the beacon interval transition process described above, after a predetermined amount of time (e.g., 1 hour), if a successful pairing does not occur within that time, the sensor electronics module switches from the high window frequency F used to facilitate pairing. window (e.g., the second state) automatically changes to the window frequency F of normal operation window (e.g., the third state). In this way, the window frequency F is not high for an extended period of time. window To waste precious battery power.

[0197] Display device window transition

[0198] In some embodiments, display devices 14, 16, 18, 20 are configured by software instructions executed by a processor of the display device to change the window used to listen for beacons from sensor electronics module 12. Doing so may conserve battery power compared to constantly having the display device listen for beacons from the sensor electronics module.

[0199] In some implementations, a state-based approach for RF windowing may be used. The following are examples of states and sub-states that may be used in an implementation, but it is understood that more or less of these states and sub-states may be used depending on the specific needs of the user. It should also be noted that although this example provides times for windowing, other times may be used depending on the specific needs of the user and the nature of the device. This example also contemplates an implementation in which a display device has a software application (which may be referred to herein as an "app") stored on the display device that is configured to cause the display device to request data from the sensor electronics module. The application may run as a background process on the display device, and while it is running in the background, the display device is not listening for beacons. The states and sub-states in this example are as follows:

[0200] 1.RFWindowState.Search: When entering this state, the display device opens the RF window for a period of time that is the same as or slightly greater than the window frequency of the sensor electronics unit during normal operation, so at least one beacon will be received during this period. For example, if the window frequency of the sensor electronics module is 5 minutes, the window in this state can be set to open for 5 minutes and 5 seconds. This state is entered when:

[0201] a. When the display device has been in RFWindowState.Idle mode for 30 minutes; or

[0202] b. When the display device is in RFWindowState.Idle and the app is called out from the background.

[0203] 2. RFWindowState.PairingSearch: This is very similar to RFWindowState.Search and opens the RF window for a slightly longer period than the window frequency of the sensor electronics unit during normal operation to ensure that at least one beacon period falls within this period. The window may be open for 5 minutes and 5 seconds, for example. This state is entered when:

[0204] a. When a user enters a new transmitter id (as discussed in more detail under the heading Transceiver Pairing Authentication Scheme); or

[0205] b. The display device has been in RFWindowState.PairingIdle mode for 30 minutes; or

[0206] c. When the display device is in RFWindowState.PairingIdle and the app is called out from the background.

[0207] 3. RFWindowState.Locked: This is the state when the display device has recently received a beacon and has a good estimate of when to expect the next beacon. This includes situations where the display device has missed receiving any beacons from the sensor electronics module during less than six consecutive previous beacon windows ("beacon periods"). This state has the following sub-states:

[0208] a.RFWindowSubstateld.OpenWaitingForBeacon: in RFWindowState.Locked

[0209] Enter this substate when the RF window is opened while in the RFWindowSubstateld.ClosedWaitingForNextBeacon state. This event is triggered by a timer in the display device to wait for the next beacon cycle to disappear while in the RFWindowSubstateld.ClosedWaitingForNextBeacon substate.

[0210] b.RFWindowSubstateld.PageExchange: Enter this state when receiving a beacon in the RFWindowState.Search, RFWindowState.PairingSearch, or RFWindowState.Locked (substate RFWindowSubstate.OpenWaitingForBeacon) states.

[0211] c.RFWindowSubstateld.ClosedWaitingForNextBeacon: This state is entered when the display device has completed processing all data packet exchanges for the current transmission window.

[0212] 4.RFWindowState.Idle: Enter this state when:

[0213] a. The display device is in RFWindowState.Locked state, but has missed 6 beacon cycles;

[0214] or

[0215] b. Indicates that the device has not obtained any beacon in the RFWindowState.Search state for 5 minutes and 5 seconds.

[0216] The display device remains in RFWindowState.Idle for 30 minutes or until the user activates the app, at which point it enters the RFWindowState.Search state.

[0217] RFWindowState.Pairingldle: Enter this state when:

[0218] a. Indicates that the device has not obtained any beacons in the RFWindowState.PairingSearch state for 5 minutes and 5 seconds.

[0219] 6.RFWindowState.Inactive: This is the state when the display device has no transmitter id entered (ie it is zero).

[0220] Transceiver pairing authentication scheme

[0221] In some embodiments, it may be necessary to pair two devices (e.g., a master and a slave) to establish a relationship between two devices that want to communicate with each other. Pairing can be achieved during the channel establishment process described above between the two devices. Establishing a channel can involve one device broadcasting a unique ID and the other device searching for and acquiring this ID.

[0222] A parameter that can be used in device pairing is the master device ID. To establish a communication channel, the master transmitter can broadcast its device ID in the beacon described above (along with some other information), and the receiver checks for the presence of the device ID of the transmitter it wants to communicate with in the received beacon. The device ID can be, for example, a 2-byte value representing a specific master device.

[0223] Although the master device ID may provide a certain level of security, since slave devices may be programmed to communicate only with a master device having a specific device ID number, additional security measures are useful in some embodiments. As described above, in order to save power by deactivating the transceiver 316 of the analyte sensor system 8, the master device ID may be activated at each update interval T. update Thus, as part of the channel establishment process, regular and repeated re-authentication can also be provided.

[0224] To provide an additional security measure, some embodiments of the present invention may use two pieces of information to pair a receiver with a particular transceiver device. The two pieces of information include the device ID described above and another value referred to herein as a sensor security code. The device ID is used as described above to filter the receipt of non-matching messages at the lowest level of the protocol stack. The sensor security code is used in a key-based authentication scheme at the software application layer of the system. In some embodiments, both the device ID and the sensor security code may be derived from an identifier associated with the sensor system 8 (e.g., a manufacturer's serial number) as described below.

[0225] like Figure 1 As seen in the embodiment of FIG. 1 , the sensor system 8 comprises two basic components, a continuous sensor 10 and an electronics module 12. The two components may be detachable from one another, for example to allow replacement of the continuous sensor portion 10. In this case, an identifier may be etched into, printed on, or otherwise attached to the housing of the electronics module portion 12.

[0226] The sensor system 8 may include seven alphanumeric characters printed on the housing of the sensor system 8, which may include an identifier for identification purposes. This alphanumeric series of characters may be used to generate a device ID used to establish a channel in the master beacon and to generate a sensor security code for additional security measures in the glucose monitoring system. To maintain good data security, the alphanumeric characters and sensor security code need not be transmitted over the wireless communication channel at any time.

[0227] In some embodiments, such as Fig. 6A The seven alphanumeric characters are converted into seven 5-position binary values ​​as shown in . These 35 bits are then used as Figure 4B , and divided into a device ID and a sensor security code. The most significant 11 bits for the device ID are shifted left by one bit and a one is inserted on the right to produce a 12-bit value. Inserting a 1 on the right prevents the device number from being set to 0x0000. To produce a 16-bit device ID value, for example, four zeros can be used for the four most significant bits of the sequence. The remaining 24 bits of the original 35 concatenated bits can be used for the sensor security code.

[0228] As an example, use Fig. 6A The binary mapping shown in converts the given seven-character alphanumeric ID 'A65S34F' into binary as follows.

[0229] A=01010

[0230] 6=00110

[0231] 5=00101

[0232] S=11010

[0233] 3=00011

[0234] 4=00100

[0235] F=01111

[0236] Concatenate these binary values ​​to produce a 35-bit sequence: 01010001100010111010000110010001111

[0238] This 35-bit sequence is then separated to produce:

[0239] 01010001100 and 010111010000110010001111

[0240] The device ID becomes 00000101 0001 1001 after adding one as the least significant bit and four zeros as the most significant bits. The other 24 bits are padded on the left with eight zeros to become a four-byte value of 0000 000001011101 0000 1100 1000 1111.

[0241] Therefore, the device ID becomes a two-byte array [0x05][0x19] used as described above in the low-level standardized communication protocol. The sensor security code becomes a four-byte array [0x00][0x5D][0x0C][0x8F] used as described below.

[0242] When the analyte sensor system 8 is initially set up, an identifier associated with the system is entered into the display device 14, 16, 18, 20. Now, the sensor system 8 and the display device 14, 16, 18, 20 can each calculate the same device ID and sensor security code using the algorithm described above.

[0243] Figure 7702, the transceiver in the sensor system 8 sends one or more message beacons, which include the device ID and the challenge value used in conjunction with the sensor security code as described below. In block 704, the display device 14, 16, 18, 20 can receive the transmission and determine whether to pair with the sensor system 8 by checking the match between the device ID in the received beacon and the device ID it searches for. If the device ID does not match, the pairing process can end as shown in block 714. If the device ID matches, a communication channel is established. The part of the communication process involved in establishing the communication channel can be processed by the transceiver circuit device 316, 338 according to the protocol established for standardized communication and embedded in the transceiver circuit device. The processor 330 does not need to manage or even understand the received beacon that does not contain the appropriate device ID.

[0244] If the communication channel is established, the challenge value is provided to the processor 330 to perform an additional authentication process as will now be described. The display device 14, 16, 18, 20 uses a predetermined algorithm and a sensor security code to process the challenge value to generate an authentication response value as shown in block 706 and generate a request for sensor data. In block 708, a hash value including the authentication response value and other information as described below is transmitted back to the sensor system 8 together with the request for sensor data. Sending a hash value can avoid constantly sending identification information directly to the analyte sensor system 8 or the display device 14, 16, 18, 20. In block 710, the sensor system 8 receives and uses the same algorithm and sensor security code to verify the hash value including the authentication response value sent by the display device 14, 16, 18, 20. If the authentication response value is valid, the sensor system 8 transmits the requested sensor data to the display device 14, 16, 18, 20 as shown in block 712. Otherwise, as shown in block 714, the pairing process can end.

[0245] By using the method described for communication authentication using a device ID and a sensor security code, two benefits can be obtained. First, security can be improved over using the device ID alone as authentication because one weak link in the device ID security is the transmission of the device ID over the air in the message beacon. When the device ID is transmitted over the air, it can be intercepted by a hacker or other unauthorized user and used to create a fake receiver that can query the sensor system for user data. In addition, computational efficiency can be improved because devices without a matching device ID do not need to use a challenge / response protocol to authenticate with the receiver device before discovering that a communication channel should not be opened between the devices.

[0246] Primary and Secondary Display Devices

[0247] In some cases, the type of data exchanged between the analyte sensor system 8 and the display device 14, 16, 18, 20 may depend on the type of display device 14, 16, 18, 20. For example, some display devices 14, 16, 18, 20 may be configured to communicate calibration data to the analyte sensor system 8 and may have additional functionality for initiating a new sensor session, setting certain reminder thresholds, etc. Such a device may be referred to as a "master" display device. In some cases, the master display device may correspond to a device that is specifically configured by the manufacturer for use with the analyte sensor system 8. The master display device may be used to configure and set up each new sensor session after the sensor components have been replaced.

[0248] In some embodiments, other display devices may have fewer functions and may be provided by a general purpose electronic device including communication circuitry that may communicate with the analyte sensor system 8 using established basic communication protocols. These display devices may be referred to as "secondary" devices and may include general purpose smart phones, smart sports watches, general purpose tablet computers, etc. The secondary display devices may not be allowed to communicate calibration data with the analyte sensor system 8 and may be limited in the type of data that may be requested and received. The reason for this may be because the secondary display devices are not approved for all the functions of the primary device by regulatory agencies, safety, reliability, etc.

[0249] In some embodiments, the secondary display device may, for example, display an analyte value, display a graph or trend arrow, provide an audible alert, or provide additional means for providing information to the user about the glucose measurement, but is not enabled to provide calibration information to the analyte sensor system 8.

[0250] In some embodiments, authentication may be dependent on the display device type, and the authentication process may allow for detection of the display device type.

[0251] For exemplary purposes only, the primary device may be referred to herein as display device 16, and the secondary display device may be referred to herein as Figure 1 One of the display devices 14, 18 and 20.

[0252] Figure 8 8 is a flow chart of an example method for establishing an authenticated communication channel between the analyte sensor system 8 and the primary device 16 or the secondary display device 14, 18. In block 802, the analyte sensor system 8 transmits a beacon containing, for example, a Figure 7 This beacon may be received at the primary display device 16 and / or the secondary display devices 14, 18 as shown in blocks 804a and 804b.

[0253] If received at the master display device 16, the master display device 16 may generate a master hash value in block 806a. The master hash value may be generated using a hash algorithm based on one or more of the identifier of the analyte sensor system 8, the key value, and the challenge value received in the beacon as shown in block 808a. The identifier may be associated with or derived from a unique identifier, such as the identifier of the analyte sensor system 8 imprinted on the housing of the sensor electronics module 12 as described above.

[0254] The hash algorithm may also generate a master hash value based on other information and identifiers, such as an identifier associated with a primary display device, to more easily allow the analyte sensor system 8 to determine the display type or various or limited capabilities of the primary display 16 .

[0255] The analyte sensor system 8 may have a list of allowable display identifiers or codes stored in memory. For example, the key value may be specific to the type of primary display device 16. For example, the key value may be a configuration key that the manufacturer provides in the primary display device 16 to allow the primary display device 16 to be used to control and configure the analyte sensor system 8. That is, the use of the configuration key may identify the display device 16 to the analyte sensor system 8 as a primary display device, thereby determining the type of data and allowed functions exchanged between the analyte sensor system 8 and the primary display device 16.

[0256] The secondary display device 14, 18 may also generate a secondary hash value in block 806b. The secondary hash value may be generated using a hash algorithm based on the analyte sensor system 8 identifier, a key value specific to the type of secondary display device 14, 18, and a challenge value. The key value may be an "authority" key that is different from the configuration key associated with the primary device and may be provided in the secondary display device 14, 18 by the manufacturer or software provider of the software implemented on the secondary display device. The authority key may identify the display device 14, 16, 18, 20 as a secondary display device 14, 18 and indicate to the sensor system 8 that the secondary display device 14, 18 has authority to display glucose data to the user.

[0257] In one example environment, there may be multiple different types of primary devices and multiple different types of secondary devices that may be allowed to communicate with the sensor system 8. Each of the secondary devices may have a different authorization key and accompanying features / restrictions for identifying the type of device, which may be facilitated or enforced in part by the analyte sensor system 8 via instructions stored in the analyte sensor system and executed by a processor of the analyte sensor system. The hash algorithm may also generate a secondary hash value based on other information (such as a display identifier) ​​that may provide additional information about the functionality of the display to further distinguish between the types of display devices 14, 16, 18, 20.

[0258] In blocks 808a and 808b, after the hash values ​​have been generated, the primary and secondary display devices 14, 16, 18, 20 may send the hash values ​​to the analyte sensor system 8. The analyte sensor system 8 may also generate its own hash value (sometimes referred to herein as an "expected hash value") for each display type from which the analyte sensor system 8 expects to receive requests. In this case, the analyte sensor system 8 may generate an expected hash value for the primary display device 16 and an expected hash value for the secondary display devices 14, 18. The expected hash value may be compared to the hash value received from the primary or secondary display device as shown in blocks 810a and 810b.

[0259] If neither of the received hash values ​​matches the expected hash values, the method ends in block 814 and the analyte sensor system 8 sends no data because the authentication fails. If the received hash value matches one of the expected hash values, the communication request from the display device can be considered authenticated and a communication channel is opened between the sensor system 8 and the display device, and data can be sent between the analyte sensor system 8 and the primary display device 16 or the secondary display devices 14, 18 as shown in blocks 812a and 812b, respectively.

[0260] To supplement blocks 812a and 812b, once authenticated, the type of data exchanged between the analyte sensor system 8 and the display device 14, 16, 18, 20 may depend on the display device type (e.g., primary or secondary). For example, as stated above, in some embodiments, the analyte sensor system 8 may be allowed to request calibration information (e.g., external calibration reference values) from the primary display device 16, but not from the secondary display device 14, 18. In fact, if a calibration data point is received from a display device 14, 16, 18, 20 identified as a secondary device, the analyte sensor system 8 may reject or ignore the data. In addition, different types of data may be exchanged based on the display device 14, 16, 18, 20 type, as each type of display device 14, 16, 18, 20 may have different limitations and be configured to display glucose measurement data in different ways. Suitable methods and systems for sending different types of data depending on the type of display device that may be used herein are described in further detail in U.S. Patent Publication No. 2009 / 0240120, filed on February 20, 2009, which is incorporated herein by reference in its entirety.

[0261] As discussed above, a configuration key or permission key may be used to identify the display device as a display device type (primary or secondary) or even to identify whether the display device is authorized to exchange data with the sensor system 8. That is, the configuration key or permission may be associated with pre-approved devices that are allowed to communicate with the sensor system. A list of approved keys may be stored in the memory of the sensor system 8, and if a device attempting to authenticate with the sensor system does not have an approved key, the device may be prevented from pairing with the sensor system.

[0262] In some implementations, multiple different devices may be approved for use with sensor system 8. In such a case, sensor system 8 may include multiple keys stored therein; for example, one key for each respective approved device type.

[0263] The keys may be stored in order of priority according to some implementations. During authentication, for example, as described with respect to block 808 in FIG. 13 , the sensor system 8 generates a hash value using the key with the highest priority (e.g., at the top of the list) in the key list. If the hash value does not match the hash value received from the display device, the sensor system generates another hash value using the next highest priority vendor code. The process repeats until there is a match or all vendor codes are used without a match. In the latter case, there will be no authentication between devices. In one example, the sensor system includes 20 different keys. Therefore, it is possible that 20 different keys can be generated during authentication.

[0264] To help with key matching, the key priority list can be adaptive. For example, the key used to generate the matching hash value can be made the highest priority key. In this way, during the next authentication process, the key is used, for example, to Figure 8 In step 808 of , a first key for the sensor system hash value is generated, and if there is a match, no more hash values ​​need to be generated.

[0265] Limiting communication with multiple primary and secondary display devices

[0266] As described above, the analyte sensor system 8 may maintain an update interval T update (by the data transmission window interval T window Only a small portion of the data is used to exchange data with the display devices 14, 16, 18, 20. In this data transmission window interval T window Analyte sensor system 8 may be able to communicate with multiple display devices 14, 16, 18, 20. However, communicating with multiple display devices 14, 16, 18, 20 may consume a lot of power. Some embodiments may limit the number of displays that can be displayed within interval T. window The number of display devices 14, 16, 18, 20 that communicate with the analyte sensor system 8 during the period. In one embodiment, the analyte sensor system 8 may limit the data transmission window interval T window In another embodiment, once the analyte sensor system 8 has communicated with a predetermined threshold number of display devices (e.g., within the transmission window T window During the communication with the three display devices), the analyte sensor 18 can reject the requests from the display devices 14, 16, 18, 20.

[0267] Fig. 9 1 is a timing diagram illustrating an example scheme for exchanging data between the analyte sensor system 8 and the plurality of display devices 14, 16, 18. The analyte sensor system 8 may be configured to send and receive data during designated time slots. window During the interval (which may be, for example, at the beginning or end of the interval), the analyte sensor system 8 may begin transmitting the beacon as described above. The primary display device 16 may successfully receive the beacon (e.g., after the analyte sensor system 8 has received the beacon). Fig. 9) and sends a data exchange request to the analyte sensor system 8 in the third time slot of the timing diagram of the master device. Once the request has been received and the master display device 16 has been authorized, data can be exchanged between the two devices as shown in the shaded time slots. As an example, the data in the first data time slot may include the most recent glucose measurement value, and the data in the subsequent time slots may include calibration data or other control or configuration data. Once the analyte sensor system 8 and the master display device 16 have completed exchanging the requested data, the communication channel can be closed.

[0268] If the data transmission window interval T window If there is still time remaining in the analyte sensor system 8, the analyte sensor system 8 can resume sending beacons. Fig. 9 As shown in FIG. 1 , the first display device 14 may attempt to communicate with the analyte sensor system 8 and window , begins searching for a beacon at the beginning of . In this case, although the first display device 14 may receive the beacon at the same time as the primary display device 16, if the analyte sensor system 8 is already communicating with the primary display device 16, it may ignore the subsequent request from the first display device 14. As will be further described below, in some embodiments, the display device type may not be a factor in determining who establishes a communication channel first. In fact, in one embodiment, the display device that responds to the beacon first will be able to establish a communication channel, and the other device may have to wait. Thus, referring to Fig. 9 If the first display device 14 responds to the beacon before the main display device 16, the channel will be initially established with the first display device 14. If the main display device 16 responds first, the first display device 14 can continue to listen for beacons from the analyte sensor system 8 until it is authenticated by the analyte sensor system 8 and a channel is established between the analyte sensor system 8 and the first display device 14. Fig. 9 As shown in , the first time display device 14 may receive the beacon and establish a channel after the analyte sensor system 8 has completed communication with the primary display device 16. The first time display device 14 may then exchange data with the analyte sensor system 8 for one or more time slots and then close the channel.

[0269] If there is time remaining in the transmission window after completing communication with the first display device 14, the analyte sensor system 8 may resume transmitting beacons.

[0270] The second display device 18 may also attempt to communicate with the analyte sensor system 8 and begin searching to windowThe secondary display device 18 may continue to search for beacons until the analyte sensor system 8 finally confirms and authenticates the secondary display device 18 after communicating with the primary display device 16 and the primary display device 14. Once authenticated, the secondary display device 18 may exchange data with the analyte sensor system 8 and close the channel. This process may continue with other display devices 20 until the specified communication interval T window The analyte sensor system 8 stops sending beacons until the beginning of another transmission window (e.g., at the next update time interval T update Beginning of

[0271] To save power, the number of display devices with which the analyte sensor system 8 communicates may be limited in several ways. For example, the analyte sensor system 8 may stop transmitting beacons or stop responding to data exchange requests after exchanging data with a predetermined number of display devices 14, 16, 18, 20. For example, the analyte sensor system 8 may only be allowed to transmit a signal in each data transmission window interval T. window Communicate with up to three devices during the session.

[0272] The maximum number of display devices that can communicate during the transmission window interval can be a variable. This variable can be set during the manufacture of the sensor electronics module 12, can be configured by the user, for example, by using the display devices 14, 16, 18, 20, or can be automatically adjusted by the sensor system 8 or the display devices 14, 16, 18, 20 based on one or more criteria. The criteria can include the monitored battery level of the analyte sensor system 8. For example, if the battery level is below a threshold, the analyte sensor system 8 can be configured to communicate with only one display device 14, 16, 18, 20. The criteria may include: (i) one or more errors detected by the sensor system 8 or the display device 14, 16, 18, 20, (ii) a currently measured, previously measured, and / or predicted glucose concentration that meets or exceeds a predetermined threshold, (iii) a glucose concentration trend of the host based on the currently measured, previously measured, and / or predicted glucose concentration, (iv) a rate of change of the glucose concentration of the host based on the currently measured, previously measured, and / or predicted glucose concentration that meets or exceeds a predetermined threshold, (v) a determination of whether the host is in or approaching hyperglycemia based on the currently measured, previously measured, and / or predicted glucose concentration, (vi) a determination of whether the host is in or approaching hypoglycemia based on the currently measured, previously measured, and / or predicted glucose concentration, (vii) an activity of the host entered by the user (e.g., exercising or sleeping), (viii) a time since a sensor session has begun (e.g., when using a new sensor 10), and (ix) a display device type.

[0273] In addition, by shortening the transmission window Twindow , limiting the types of devices that can communicate with the sensor system, limiting the type of data that can be exchanged between the sensor system and the display devices 14, 16, 18, 20, etc. to complete the communication based on the battery level.

[0274] It should be appreciated that while the above functionality has been described with respect to dividing and restricting communications based on time slots, the principles described herein may be applicable to other communication protocols that use other multiplexing techniques, such as frequency division multiplexing.

[0275] In addition, although Fig. 9 The analyte sensor system 8 is shown communicating with the primary display device 16 first and then with the two secondary display devices 14, 18, but it should be understood that the display device order and type may not matter. Thus, the analyte sensor system 8 may communicate with the secondary display device 14 first and then with the primary display device 16. In some embodiments, the analyte sensor system 8 may communicate with the secondary display device 14 at the communication interval T. primary During the communication interval T, the analyte sensor system 8 communicates only with the primary display device 16. In other embodiments, the analyte sensor system 8 may communicate with the primary display device 16 during the communication interval T. secondary During this time, only the secondary display devices 14 and 18 are communicated with.

[0276] In some cases, it may be important to always allow the primary display device 16 to communicate during the transmission window. Thus, the analyte sensor system 8 may implement a priority scheme to ensure that the analyte sensor system 8 communicates with the primary display device 16 during the transmission window. In one embodiment, the analyte sensor system 8 may be set up to communicate with the primary display device 16 during the transmission window interval T. window The specified time interval (T primary ). In the transmission window T window T at the beginning of primary In T, the analyte sensor system 8 can be configured to respond only to and authenticate with the primary display device 16 and ignore other requests. primary After the interval has expired, the secondary display devices 14, 18 may have an opportunity to establish a channel in addition to the primary display device.

[0277] It may also be necessary to limit the use of the secondary display devices 14, 18 when the primary display device 16 is able to exchange data with the analyte sensor system 8. For example, the primary display device 16 may include functionality (such as special reminders or alarms) that helps ensure that the user maintains safe glucose levels. Management or safety policies may therefore require that the primary display device 16 is always used. Thus, to help ensure the use of the primary display device 16, if the analyte sensor system 8 has been in a given transmission window T, the analyte sensor system 8 may be able to communicate with the analyte sensor system 8. windowIf the analyte sensor system 8 is configured to send glucose information to the primary display device 16, the analyte sensor system 8 may only allow communication with the secondary display devices 14, 18.

[0278] When replacing a sensor component (e.g., a new sensor 10 used in the sensor system 8), a new sensor session may be established. In some embodiments, glucose values ​​may not be allowed to be communicated to the secondary devices 14, 18 until an initiation sensor session is performed between the main display device 16 and the sensor system 8. The initiation process may include providing calibration data for the sensor session and setting a reminder threshold. Once the main display device 16 has been used to initiate a session, the secondary display devices 14, 18 may be allowed to exchange data with the sensor system 8, such as receiving glucose measurements and performing various functions (e.g., displaying estimated glucose values ​​(EGV), trend graphs, arrows, sound alarms), even if the main display device 16 is not currently adjacent to or exchanging data with the analyte sensor system 8. However, certain functions of the secondary display devices 14, 18 may be limited. In this way, the communication between the secondary display devices 14, 18 and the analyte sensor system 8 may be based on the communication between the main display device 16 and the analyte sensor system 8. In another embodiment, the analyte sensor system 8 may not actively measure glucose concentration values ​​until a sensor session with the main display device 16 is initiated. In this case, the analyte sensor system 8 may not transmit any information, and the secondary display devices 14, 18 will not be able to receive any information or establish a channel. In this case, the secondary display devices 14, 18 will not be able to communicate until the primary display device 16 initiates a sensor session.

[0279] Fig.10 1002, the analyte sensor system 8 may receive a request for sensor data from the secondary display device 14, 18 during a transmission window. In block 1004, the analyte sensor system 8 may determine whether a communication channel has been established between the analyte sensor system 8 and the primary display device 16 during the transmission window. If a communication channel has not been established with the primary display device 16, the method may end in block 1010, and the analyte sensor system 8 may deny communication with the secondary display device 14, 18. For example, if a time period of the transmission window is reserved for communication with the primary display device 16 and no communication occurs, any subsequent request from the secondary display device 14, 18 may be denied. If a communication channel has been established with the primary display device 16 during the transmission window, the analyte sensor system 8 may authenticate and establish a communication channel with the secondary display device 14, 18 as shown in block 1006. In block 1008, the analyte sensor system 8 may then transmit sensor data to the secondary display device 14, 18.

[0280] Active primary display device determination

[0281] In some embodiments, although many display devices may be allowed to communicate with the sensor electronics module 12, it may be desirable to limit the master display devices used with the sensor electronics module to one at any given time. Some embodiments provide rules for determining whether a given master display device is currently the active master display device. If a user attempts to perform any action from an inactive controller, the user may be notified that the device is not currently the active master display device and be presented with instructions via the device to make the device the active controller. For example, if the user loses the active master device or wants to switch to a newer master display device, it may be desirable to switch the active master device.

[0282] The following is an implementation of the active controller determination process. Here, the sensor system 8 maintains an identifier ("primary display device id") that is exclusive to the current active primary display in its memory. During the establishment of a communication channel with the sensor system 8, the primary display device can request the current active primary display id from the sensor system. In one implementation, the primary display device requests a reminder data page, which includes information indicating the current reminder settings and the active primary display id stored in the sensor system. If the primary display device id in the message indicates that the sensor system 8 has communicated with the primary display (indicated by a non-matching primary display device id) or if no other primary display device has communicated (for example, indicated by all zeros for the id), the primary display will display instructions to the user to confirm whether the user intends to make this display device a new active primary display device. If the user confirms, the primary display device generates a new two-byte random id and sends the random id to the sensor system 8 as the primary display device id, and the sensor system switches to the new primary display device id.

[0283] After switching to the new main display device id, the sensor system 8 sends a message indicating that the change is up to a predetermined number of subsequent window beacon cycles, such as three beacon cycles. The message can be a predetermined position in the data page of each beacon indicating the change. The main display device receiving the message can request the main display device id stored in the sensor system from the sensor system, and compares the main display device id received with the main device id stored in its own memory. If the main display id from the sensor system does not match its own main display id, the main display can display the instruction indicating this change to the user and make it itself an inactive main display. In an implementation, the inactive main display will then have only the function of a secondary display device. If the user needs to start using this display as an active main display again, the user can perform a new pairing with the sensor system 8 as discussed above.

[0284] In some implementations, if the master display misses more than a predetermined number of beacon periods (such as three beacon periods), the master display device will then automatically confirm that it is still the active master display device using the process described above.

[0285] Display device handoff

[0286] Since the data transmission window interval T of the analyte sensor system 8 window It may only be a fraction (e.g., 30 seconds) of a much longer update interval (e.g., five minutes), so it may be desirable for display devices 14, 16, 18, 20 to have information about the time at which T window The specific information of the time when it is turned on so as to know when to listen for the beacon sent by the analyte sensor system 8.

[0287] As described above, when the sensor electronics module is first activated (e.g., when power is first supplied to it or after a battery replacement), there may be a process to be completed using the master display device 16 to establish communication and synchronize the timing of a later transmission window. For example, upon activation, the transceiver 316 may initially transmit beacons continuously or more frequently into a transmission window until communication is established with the master display device 16. In this way, the master display device 16 may not need to be aware of the transmission window T. window Once the channel is initially opened, the analyte sensor system 8 may send synchronization information to the master display device 16, or may derive synchronization information based on the timing of the beacon transmission, so that the master display device knows the transmission window T. window The primary display device 16 may thus be able to know the timing for establishing communications with the analyte sensor system 8 within the life of the battery (and within a number of sensor sessions).

[0288] The synchronization information may not be initially available to the secondary display device 14, 18; for example, if the secondary device 14, 18 has not yet established communication with the sensor system. In such a case, the secondary display device 14, 18 may not know when the transmission window begins and thus search for the beacon at the wrong time. This may cause the secondary display device 14, 18 to miss an opportunity to establish a communication channel with the sensor system 8 during the transmission window. Thus, some embodiments allow the secondary device to learn the transmission window synchronization information. The primary display device 16 may provide the synchronization information to the secondary display device 14, 18.

[0289] In one embodiment, the display of the primary display device 16 can display an indication of the remaining time until the next transmission window of the analyte sensor system 8 opens based on the synchronization information previously collected from the sensor system and now stored in the primary display device. The indication can be a graphical indication (graphic bar, pie chart, etc.) of a timer that counts down to the time when the window is scheduled to open next, or it can be a numerical timer that increments to the remaining time until the window is scheduled to open next. The user of the secondary display device 14, 18 can monitor the remaining time and then provide input to the secondary display device 14, 18 (e.g., pressing a button or other activation trigger) when the transmission window of the analyte sensing system 8 is about to open. The user input can activate the secondary display device 14, 18 to begin searching for beacons.

[0290] In another embodiment, the primary display device 16 may electronically communicate sensor system synchronization information to the secondary display devices 14 , 18 via wired or wireless communications. Fig.11 1 is a flow chart of an example method for providing sensor system synchronization information from the primary display device 16 to the secondary display devices 14, 18. In block 1102, the primary display device 16 may receive a beacon from the analyte sensor system 8. The timing of the transmission window for the analyte sensor system 8 (e.g., each data transmission window interval T ) may be included in the beacon or derived from the beacon. window In block 1104, a communication channel can be established between the main display device 16 and the secondary display devices 14, 18 that want to obtain timing information for establishing a communication channel with the analyte sensor system 8. In block 1106, the main display device 16 can then send beacon information that may include timing information for establishing a communication channel with the analyte sensor system 8 to the secondary display devices 14, 18. The beacon information may include a current transmission time (e.g., from the moment when the main display opens its channel) and an update interval equal to the amount of time remaining until the next transmission of the glucose device. In addition, more information can be exchanged between the secondary display devices 14, 18 and the main display device 16, such as previous glucose data information that can be stored on the main display device 16.

[0291] Once the secondary display device 14, 18 has received the beacon information, the secondary display device 14, 18 may then establish a communication channel with the analyte sensor system 8 based on the beacon information as shown in block 1108. Additionally, in some embodiments, an authentication process similar to that described above may be used between the primary display device 16 and the secondary display devices 14, 18 in block 1104 to establish communication.

[0292] Although the above description mainly describes the handover from the main device to the secondary display device, it is understood that this description is only an example, and if it is desired to use a new main display device, the handover can be similarly between the first main display device and the second main display device. Similarly, the handover can be performed between the secondary display devices in some implementations.

[0293] Interleaving transmission and measurement sessions

[0294] The more operations that are performed substantially simultaneously on the analyte sensor system 8, the more power may be consumed during that time. For example, if the analyte sensor system 8 is transmitting sensor data during the same time that the analyte sensor system 8 is sampling and / or processing sensor readings, significant power consumption may occur. In order to reduce the strain on battery use or the need to use a battery that can provide a large amount of power at a given time, some embodiments interleave transmission and measurement sessions to avoid simultaneous transmission when measurements are taken and processed. This can provide that the analyte sensor system 8 transmits only between sessions in which sensor data sampling and any subsequent processing are performed. In addition, the amount of time of the transmission window can be limited to ensure that it does not overlap with sampling and processing.

[0295] Fig. 12A is a timing diagram of an example timing scheme for transmitting data and obtaining and processing analyte sensor measurements. Fig. 12A As shown in update It is divided into two periods: sensor measurement and processing period 1220a, 1220b and data communication period 1230a, 1230b. update For a five minute interval, a four minute, thirty second measurement period 1220a may, for example, be followed by a thirty second transmission window 1230a. Measurement circuitry 310 may be powered down during transmission window 1230a, and transceiver 316 may be powered down during measurement period 1220a. This may be repeated for each update interval.

[0296] In some cases, the time length of measurement period 1220 may vary. In these cases, the time length of transmission window 1230 may be adjusted to ensure that it does not overlap with the measurement period. In addition, analyte sensor system 8 may send information in the beacon regarding the total time length that the current transmission window will be open or how much time remains until the current transmission window closes.

[0297] Fig. 12B12 is a flow chart of an example method for interleaving an analyte sensor measurement and processing period with a data communication period for transmitting a glucose measurement value. In block 1202, the analyte sensor system 8 may activate the sensor measurement circuit device 310 and deactivate the transceiver 316 during a first time interval. In block 1204, the analyte sensor system 8 may obtain and process sensor readings during the first time interval. Once sampling and processing are completed, the analyte sensor system 8 may deactivate the sensor measurement circuit device 310 and activate the transceiver 316 during a second time interval corresponding to the data transmission window. In block 1208, the analyte sensor system 8 may then transmit sensor data to the display device 14, 16, 18, 20 during the second time interval. This process may be repeated continuously for each update interval.

[0298] It should be understood that the entire time interval may not be required for sensor measurement and processing. Thus, measurement circuitry 310 may also be deactivated during unused portions of the time interval. Thus, Fig. 12B Activation and deactivation in may include selectively powering down / powering up some or all components of sensor measurement circuitry 310 and transceiver 316, or selectively placing sensor measurement circuitry 310 and transceiver 316 in a low power mode, such as a sleep mode.

[0299] Provide missing data to display device

[0300] The analyte sensor system 8 may continuously store past glucose measurements. The display device 14, 16, 18, 20 may not always have the complete history of glucose data stored on the analyte sensor system 8. For example, the display device 14, 16, 18, 20 may have been out of range of the analyte sensor system 8 for a period of time, or may be reused in the middle of a sensor session and want to access missing data stored on the analyte sensor system 8.

[0301] Fig.13A Examples of data structures 1310a, 1310b, and 1310c that may be stored on the analyte sensor system 8 and include glucose measurements are shown. The data structures 1310a, 1310b, and 1310c may be formatted as data files, each with a series of glucose measurements. The data structures 1310a, 1310b, and 1310c may hold glucose measurements corresponding to a specific time period during which the stored glucose measurements were obtained. For example, each data structure 1310a, 1310b, and 1310c may correspond to glucose measurements for a twenty-four hour period.

[0302] One embodiment of the present invention provides for allowing the display devices 14, 16, 18, 20 to request and receive past glucose measurements from the analyte sensor system 8 in addition to the normal transmission of the most recent glucose measurement values.

[0303] Fig. 13B It is a flowchart of an example method of transmitting sensor data from an analyte sensor system 8 to a display device 14, 16, 18, 20. The display device 14, 16, 18, 20 may be able to determine the data range related to the missed glucose measurement from the analyte sensor system 8 that it wishes. In block 1302, the analyte sensor system 8 may also receive a request for a previous glucose measurement 1312 in addition to the glucose measurement value normally included in the periodic data transmission. In block 1304, the analyte sensor system 8 may then transmit a data set corresponding to a certain time interval of the stored measurement value, the data set including the requested glucose measurement value. The analyte sensor system 8 may be specifically formatted for transmission (e.g., compression). In one aspect, the entire data set 1310a (e.g., data file) may be transmitted compared to only transmitting the requested data range related to the glucose measurement. In this way, the transmitted data set 1310 may include a data range related to the glucose measurement that exceeds the requested range. This may reduce the processing time and power required to retrieve and send only the data range related to the glucose measurement specifically requested. This may provide significant power savings which may allow the battery of the sensor system 8 to last longer.

[0304] Additionally, as described above, the primary display device 16 may also be configured to provide missing data values ​​to the secondary display devices 14 , 18 to avoid wasting processing power on the analyte sensor system 8 to transmit missing data points.

[0305] Technical support data exchange

[0306] In some implementations, the sensor system can monitor and log possible technical issues associated with the sensor system 8. Technical issues can be logged in a technical support log file stored in the memory of the sensor system.

[0307] The user of the sensor system 8 may identify a problem or otherwise determine that it is necessary to contact technical support to resolve the problem or need. At this point, technical support may want the user to obtain some or all of the technical support log files from the sensor system 8. However, because the sensor system 8 may not have a display and the display device may only be able to communicate with the sensor system infrequently (only when the next transmission window is open), the user may have to wait a significant amount of time before being able to obtain the technical support log files from the sensor system and display the information in the files on the display device or transmit (e.g., via the Internet) some or all of the technical support log files from the display device to a computer associated with technical support.

[0308] In addition, it may be desirable to collect sensor data and / or technical support log files to support analyzing sensors or debugging sensor system software or firmware. In these situations, it may be desirable to be able to collect this information without disturbing the user (e.g., by not requiring the user to press a button for downloading).

[0309] In some implementations, the sensor system 8 may send a message to the display device at any time that the sensor system determines that the technical support information stored in the technical support log file is worthy of display on the display device. For example purposes, such occurrences may include: (i) the sensor system is out of calibration after calibration; (ii) the sensor system is not out of calibration, but the difference between the reference value and the corresponding estimated glucose value exceeds a predetermined amount; (iii) the sensor system software or firmware encounters a particular type of error, even though the system determines that it has resolved the error; (iv) the sensor system firmware or software encounters an error that causes the user to be alerted to the error via the display device; and (v) a period of time during use of the sensor when the sensor system detects noise or other types of deviations above a predetermined level.

[0310] When the display device receives the message, it can be programmed to automatically request some or all of the support file logs. The display device can also automatically send the support log files to the technical support computer through a communication network (e.g., a cellular network if the display device is a smart phone, or through the Internet if the display device is a PC connected to the Internet). If the communication network is not immediately available, the display device can send the support log file technical support when the display device is connected to the appropriate communication network. In this way, when the user calls technical support to solve a problem or need, the display device and / or technical support may already have technical information on hand.

[0311] In some embodiments, the message sent by the sensor system is a bit in a data page sent from the sensor system that indicates the presence of technical support information. The data page is a beacon data page in some implementations. Having this bit can provide flexibility for obtaining technical support data without specifying all conditions under which the display device needs to obtain a technical support log file. For example, if similar conditions have occurred in the recent past and technical support has been performed at a previous time, the display device can also choose not to obtain a technical support log file from the sensor system.

[0312] Methods and apparatus that may be suitable for use in conjunction with aspects of the preferred embodiments are disclosed in the following patents: U.S. Patent No. 4,994,167; U.S. Patent No. 4,757,022; U.S. Patent No. 6,001,067; U.S. Patent No. 6,741,877; U.S. Patent No. 6,702,857; U.S. Patent No. 6,558,321; U.S. Patent No. 6,931,327; U.S. Patent No. 6,862,465; U.S. Patent No. 7,074,307; U.S. Patent No. 7,081,195; U.S. Patent No. 7,108,778; U.S. Patent No. 7,110,803; U.S. Patent No. 7,192,450; U.S. Patent No. 7,226,978; and U.S. Patent No. 7,310,544.

[0313] Methods and apparatus suitable for use in conjunction with aspects of the preferred embodiments are disclosed in the following U.S. patent publications: U.S. Patent Publication No. US-2005-0176136-A1; U.S. Patent Publication No. US-2005-0251083-A1; U.S. Patent Publication No. US-2005-0143635-A1; U.S. Patent Publication No. US-2005-0181012-A1; U.S. Patent Publication No. US-2005-0177036-A1; U.S. Patent Publication No. US-2005-0124873-A1; U.S. Patent Publication No. US-2005-0115832-A1; U.S. Patent Publication No. US-2 005-0245799-A1; U.S. Patent Publication No. US-2005-0245795-A1; U.S. Patent Publication No. US-2005-0242479-A1; U.S. Patent Publication No. US-2005-0182451-A1; U.S. Patent Publication No. US-2005-0056552-A1; U.S. Patent Publication No. US-2005-0192557-A1; U.S. Patent Publication No. US-2005-0154271-A1; U.S. Patent Publication No. US-2004-0199059-A1; U.S. Patent Publication No. US-2005-0054909-A1; U.S. Patent Publication No. US-2005-0051427-A1; US ​​Patent Publication No. US-2003-0032874-A1; US ​​Patent Publication No. US-2005-0103625-A1; US ​​Patent Publication No. US-2005-0203360-A1; US ​​Patent Publication No. US-2005-0090607-A1; US ​​Patent Publication No. US-2005-0187720-A1; US ​​Patent Publication No. US-2005-0161346-A1; US ​​Patent Publication No. US-2006-0015020-A1; US ​​Patent Publication No. US-2005-0043598-A1; US ​​Patent Publication No. US-2005-0033132-A1; US ​​Patent Publication No. US-2005-0031689-A1; US ​​Patent Publication No. US-2004-0186362-A1; US ​​Patent Publication No. US-2005-0027463-A1; US ​​Patent Publication No. US-2005-0027181-A1; US ​​Patent Publication No. US-2005-0027180-A1; US ​​Patent Publication No. US-2006-0020187-A1; US ​​Patent Publication No. US-2006-0036142-A1; US ​​Patent Publication No. US-2006-0020192-A1;U.S. Patent Publication No. US-2006-0036143-A1; U.S. Patent Publication No. US-2006-0036140-A1; U.S. Patent Publication No. US-2006-0019327-A1; U.S. Patent Publication No. US-2006-0020186-A1; U.S. Patent Publication No. US-2006-0036139-A1; U.S. Patent Publication No. US-2006-0020191-A1; U.S. Patent Publication No. US-2006-0020188-A1; U.S. Patent Publication No. US-2006-0036141-A1; U.S. Patent Publication No. US-2006-0020 190-A1; U.S. Patent Publication No. US-2006-0036145-A1; U.S. Patent Publication No. US-2006-0036144-A1; U.S. Patent Publication No. US-2006-0016700-A1; U.S. Patent Publication No. US-2006-0142651-A1; U.S. Patent Publication No. US-2006-0086624-A1; U.S. Patent Publication No. US-2006-0068208-A1; U.S. Patent Publication No. US-2006-0040402-A1; U.S. Patent Publication No. US-2006-0036142-A1; U.S. Patent Publication No. US-20 06-0036141-A1; U.S. Patent Publication No. US-2006-0036143-A1; U.S. Patent Publication No. US-2006-0036140-A1; U.S. Patent Publication No. US-2006-0036139-A1; U.S. Patent Publication No. US-2006-0142651-A1; U.S. Patent Publication No. US-2006-0036145-A1; U.S. Patent Publication No. US-2006-0036144-A1; U.S. Patent Publication No. US-2006-0200022-A1; U.S. Patent Publication No. US-2006-0198864-A1; U.S. Patent Publication No. This patent number is US-2006-0200019-A1; US ​​patent publication number is US-2006-0189856-A1; US ​​patent publication number is US-2006-0200020-A1; US ​​patent publication number is US-2006-0200970-A1; US ​​patent publication number is US-2006-0183984-A1; US ​​patent publication number is US-2006-0183985-A1; US ​​patent publication number is US-2006-0195029-A1; US ​​patent publication number is US-2006-0229512-A1; US ​​patent publication number is US-2006-0222566-A1;U.S. Patent Publication No. US-2007-0032706-A1; U.S. Patent Publication No. US-2007-0016381-A1; U.S. Patent Publication No. US-2007-0027370-A1; U.S. Patent Publication No. US-2007-0027384-A1; U.S. Patent Publication No. US-2007-0032717-A1; U.S. Patent Publication No. US-2007-0032718-A1; U.S. Patent Publication No. US-2007-0059196-A1; U.S. Patent Publication No. US-2007-0066873-A1; U.S. Patent Publication No. US-2007-0093704-A1; U.S. US Patent Publication No. US-2007-0197890-A1; US ​​Patent Publication No. US-2007-0173710-A1; US ​​Patent Publication No. US-2007-0163880-A1; US ​​Patent Publication No. US-2007-0203966-A1; US ​​Patent Publication No. US-2007-0213611-A1; US ​​Patent Publication No. US-2007-0232879-A1; US ​​Patent Publication No. US-2007-0235331-A1; US ​​Patent Publication No. US-2008-0021666-A1; and US Patent Publication No. US-2008-0033254-A1. ;

[0314] Methods and apparatus suitable for use in conjunction with aspects of the preferred embodiments are disclosed in the following U.S. patent applications: U.S. patent application Ser. No. 09 / 447,227, filed Nov. 22, 1999, and entitled "DEVICE AND METHOD FOR DETERMINING ANALYTE LEVELS"; U.S. patent application Ser. No. 11 / 654,135, filed Jan. 17, 2007, and entitled "POROUS MEMBRANES FOR USE WITH IMPLANTABLE DEVICES"; U.S. patent application Ser. No. 11 / 654,140, ​​filed Jan. 17, 2007, and entitled "MEMBRANES FOR AN ANALYTE SENSOR"; U.S. patent application Ser. No. 11 / 543,396, filed Oct. 4, 2006, and entitled "ANALYTE SENSOR"; U.S. patent application Ser. No. 11 / 543,490, filed Oct. 4, 2006, and entitled "ANALYTE U.S. Patent Application No. 11 / 543,404, filed on October 4, 2006 and entitled “ANALYTE SENSOR”; U.S. Patent Application No. 11 / 691,426, filed on March 26, 2007 and entitled “ANALYTE SENSOR”; U.S. Patent Application No. 11 / 691,432, filed on March 26, 2007 and entitled “ANALYTE SENSOR”; U.S. Patent Application No. 11 / 691,424, filed on March 26, 2007 and entitled “ANALYTE SENSOR”; and U.S. Patent Application No. 11 / 691,466, filed on March 26, 2007 and entitled “ANALYTE SENSOR”.

[0315] Although the disclosure has been specifically illustrated and described in the drawings and the foregoing description, such illustration and description are to be regarded as examples or exemplifications rather than limitations. The disclosure is not limited to the disclosed embodiments. Those skilled in the art can understand and implement changes to the disclosed embodiments from the reading of the drawings, the disclosure, and the appended claims when implementing the disclosure claimed for protection.

[0316] All references cited herein are hereby incorporated by reference in their entirety. To the extent that publications and patents or patent applications incorporated by reference conflict with the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such conflicting material.

[0317] Unless otherwise defined, all terms (including technical and scientific terms) will be given their ordinary and customary meanings to those of ordinary skill in the art, and will not be limited to special or customary meanings unless expressly defined as such herein. It should be noted that the use of a particular term in describing certain features or aspects of the disclosure should not be interpreted as meaning that the term is redefined herein to include any specific characteristics of the feature or aspect of the disclosure with which the term is associated. Unless expressly stated otherwise, the terms and phrases used in this application and its variations (especially in the appended claims) should be interpreted as open-ended rather than limiting. As an example of the foregoing, the term 'including' should be interpreted as meaning 'including but not limited to', 'including but not limited to', etc.; as used herein, the term 'comprising' is synonymous with 'including', 'comprising' or 'characterized by', and is all-inclusive or open-ended, and does not exclude additional, unlisted units or method steps; the term 'having' should be interpreted as 'having at least'; the term 'includes' should be interpreted as 'including but not limited to'; the term 'example' is used to provide an example instance of the items discussed rather than an exhaustive or limiting list thereof; the adjective Terms such as 'known', 'normal', 'standard' and similar meanings should not be interpreted as limiting the items described to a given time period or items available as of a given time, but instead should be interpreted as covering known, normal or standard technologies that may be available or known now or at any time in the future; and the use of terms such as 'preferably', 'preferred', 'desirable' or 'desirable' and words of similar meanings should not be interpreted as meaning that certain features are critical, essential or even important to the structure or function of the present invention, but instead are understood to be merely intended to highlight alternative or additional features that may or may not be utilized in a specific embodiment of the present invention. Similarly, unless explicitly stated otherwise, a group of items linked with the conjunction 'and' should not be interpreted as requiring that each of those items be present in the grouping, but should be interpreted as 'and / or'. Similarly, unless explicitly stated otherwise, a group of items linked with the conjunction 'or' should not be interpreted as requiring mutual exclusivity among the group, but should be interpreted as 'and / or'.

[0318] Where a range of values ​​is provided, it is understood that the upper and lower limits and every intervening value between the upper and lower limits of the range are encompassed within the embodiments.

[0319] With respect to the use of substantially any plural and / or singular terms herein, those skilled in the art may convert from the plural to the singular and / or from the singular to the plural as appropriate for the context and / or application. For clarity, various singular / plural arrangements may be expressly set forth herein. The indefinite article "a / a" does not exclude a plurality / multiple. A single processor or other unit may perform the functions of several items recited in a claim. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. Any reference signs in a claim should not be interpreted as limiting the scope.

[0320] Those skilled in the art will also understand that if a specific number of claim recitations to be introduced is intended, such intention will be expressly recorded in the claim, and in the absence of such a record, no such intention exists. For example, as an aid to understanding, the following appended claims may contain the use of the introduction phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be interpreted as meaning that the introduction of the claim recitation with the indefinite article "one / a" limits any particular claim containing such an introduced claim recitation to an embodiment containing only one such recitation, even when the same claim includes the introduction phrases "one or more" or "at least one" and an indefinite article (such as "one / a") (for example, "one / a" should generally be interpreted as meaning "at least one" or "one or more"); this is also true for the use of definite articles used to introduce claim recitations. In addition, even if the specific number of claim recitations to be introduced is expressly recorded, those skilled in the art will recognize that generally such a record should be interpreted as meaning at least the number recorded (for example, a pure record such as "two records" without other modifiers generally means at least two records or two or more records). In addition, in those instances where a convention similar to "at least one of A, B, and C, etc." is used, generally speaking, such construction is intended that a person skilled in the art will understand the meaning of the convention (e.g., "a system having at least one of A, B, and C" will include but is not limited to systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C, etc.). In those instances where a convention similar to "at least one of A, B, or C, etc." is used, generally speaking, such construction is intended that a person skilled in the art will understand the meaning of the convention (e.g., "a system having at least one of A, B, or C" will include but is not limited to systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C, etc.). A person skilled in the art will also understand that in fact any separate word and / or phrase presenting two or more alternative items, whether in the description, in the claims, or in the drawings, should be understood to contemplate the possibility of including one of the items, either of the items, or both of the items. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B" or "A and B."

[0321] All numerical values ​​expressing the quantity of ingredients, reaction conditions, etc. used in the specification will be understood to be modified by the term 'about' in all instances. Therefore, unless otherwise indicated, the numerical parameters set forth herein are approximate values ​​that may vary depending on the desired properties sought to be obtained. At least, and without attempting to limit the application of the doctrine of equivalents to the scope of any claim in any application claiming priority to this application, each numerical parameter should be interpreted according to the number of significant digits and ordinary rounding methods.

[0322] In addition, although the foregoing has been described in more detail by way of illustration and example for the sake of clarity and understanding, it will be clear to those skilled in the art that certain changes and modifications may be implemented. Therefore, the description and examples should not be interpreted as limiting the scope of the present invention to the specific embodiments and examples described herein, but in fact also cover all modifications and alternatives that fall within the true scope and spirit of the present invention.

Claims

1. A method for providing analyte sensor measurements from a first communication device associated with an analyte sensor to a second communication device configured to provide a user with access to analyte values ​​and / or information derived from the analyte values, the method comprising: receiving, from the first communication device, a request from a second communication device for a previous analyte sensor measurement other than the analyte sensor measurement of the predetermined analyte sensor measurement transmission; and A data set of analyte sensor measurement values ​​corresponding to a predetermined time interval including the requested previous analyte sensor measurement values ​​is transmitted from the first communication device to the second communication device. 2 . The method of claim 1 , wherein the previous analyte sensor measurements comprise a subset of the data set of analyte sensor measurements.

3. The method of any of claims 1-2, wherein the predetermined time interval corresponds to a twenty-four hour period of analyte sensor measurements.

4. A system for monitoring an analyte level of a host, the system being configured to perform the method of any one of claims 1-3, wherein a first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

5. A method for authorizing an analyte sensor data exchange between a first communication device associated with an analyte sensor and a second communication device configured to provide a user with access to an analyte value and / or information derived from the analyte value, comprising: sending a challenge value from a first communication device associated with the analyte sensor to a second communication device; generating, in the second communications device, a first hash value using, at least in part, one or more of the challenge value, an identifier of the first communications device, or a key value; sending the first hash value from the second communication device to the first communication device; generating a second hash value and a third hash value using the first communication device; comparing the second hash value and the third hash value with the first hash value using the first communication device; and Analyte sensor data is sent only if at least one of the second hash value or the third hash value matches the first hash value. 6 . The method of claim 5 , further comprising determining a type of the second communication device based on a match between the first hash value and the second hash value or a match between the first hash value and the third hash value.

7. The method of claim 5, wherein the key value is a first value if the second communications device is of a first type, and wherein the key value is a second value if the second communications device is of a second type.

8. A method according to claim 7, wherein the type of the second device corresponds to one of a primary device or a secondary device, wherein the primary device is configured to communicate analyte calibration data to the first communication device, and wherein the first communication device is configured to reject analyte calibration data received from the secondary communication device.

9. The method of any of claims 5-8, wherein the first hash value is generated using a display identifier.

10. The method of claim 6, wherein sending analyte sensor data comprises sending analyte sensor data based at least in part on a type of the second communication device.

11. A system for monitoring an analyte level of a host, the system being configured to perform the method of any one of claims 5-10, wherein the first communication device comprises a sensor electronics module, and wherein the sensor electronics module is configured to electronically couple to an analyte sensor and use the analyte sensor to generate an analyte data stream.

12. A method for synchronizing a time for transmitting data between a first communication device associated with an analyte sensor and a primary communication device and a secondary communication device configured to provide a user with access to an analyte value and / or information derived therefrom, the method comprising: receiving, at a master communication device, a beacon from the first communication device during a transmission time window defined by the first communication device; establishing a first communication channel between the primary communication device and the secondary communication device; transmitting beacon information from the primary communication device to the secondary communication device, wherein the beacon information includes timing information for establishing a communication channel with the first communication device; and A communication channel is established between the first communication device and the secondary communication device based on the beacon information.

13. The method of claim 12, wherein establishing the first communication channel between the primary communication device and the secondary communication device comprises performing an authentication protocol between the primary communication device and the secondary communication device.

14. The method according to any of claims 12-13, wherein the first communications device is configured to periodically transmit the beacon in a series of periodic transmission time windows separated by update time intervals.

15. The method according to any of claims 12-14, wherein the timing information comprises information about a time corresponding to a start of the transmission time window.

16. A system for monitoring an analyte level of a host, the system being configured to perform the method of any of claims 12-15, wherein a first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

17. A method for processing data from an analyte sensor and transmitting the data between a first communication device associated with the analyte sensor and a second communication device configured to provide a user with access to an analyte value and / or information derived from the analyte value, comprising: activating the analyte sensor data processing circuit and deactivating a transceiver of a first communication device associated with the analyte sensor during a first time interval; obtaining and processing analyte sensor data during said first time interval; deactivating the analyte sensor data processing circuitry and activating the transceiver of the first communication device during different second time intervals; and Analyte sensor data is transmitted to the second communication device during the second time interval.

18. The method of claim 17, wherein activating and deactivating the analyte sensor data processing circuit comprises powering up and down the analyte sensor data processing circuit.

19. The method of any of claims 17-18, wherein activating and deactivating the analyte sensor data processing circuitry comprises activating and deactivating a low power mode of the analyte sensor data processing circuitry.

20. The method of any of claims 17-19, wherein activating and deactivating the transceiver comprises powering up and down the transceiver.

21. The method of any of claims 17-20, wherein activating and deactivating the transceiver comprises activating and deactivating a low power mode of the transceiver.

22. A system for monitoring an analyte level of a host, the system being configured to perform the method of any of claims 17-21, wherein the first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor.

23. A method for processing data from an analyte sensor, comprising: obtaining and processing analyte sensor data using an analyte sensor data device associated with the analyte sensor during a first time interval; A transmission time window is opened to accept a request to establish a communication channel to communicate to the analyte sensor data device during a second, different time interval, wherein the first time interval and the second time interval do not overlap.

24. A system for monitoring an analyte level of a host, configured to perform the method of claim 23, wherein the first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and generate an analyte data stream using the analyte sensor.

25. A method for transmitting data between a first communication device associated with an analyte sensor and a primary communication device and a secondary communication device configured to provide a user with access to an analyte value and / or information derived from the analyte value, comprising: establishing a communication channel between the secondary communication device and the first communication device during a transmission time window of the sensor session; determining whether a primary communication device has previously communicated with the first communication device during the sensor session; and If the primary communication device has not communicated with the first device during the sensor session, a request for data or a command sent by the secondary communication device to the first communication device is rejected.

26. The method of claim 25, wherein the communication between the primary communication device and the first communication device includes control information for initiating a sensor session.

27. A system for monitoring an analyte level of a host, the system being configured to perform the method of any of claims 25-26, wherein the first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and to generate an analyte data stream using the analyte sensor.

28. A method of transmitting data between a first communication device associated with an analyte sensor and a primary communication device and a secondary communication device, each of the primary communication device and the secondary communication device being configured to provide a user with access to an analyte value and / or information derived from the analyte value, comprising: determining whether a first communication channel has been established between the first communication device and the primary communication device during the time window; and A second communication channel between the first communication device and a secondary communication device is established during the time window only if the first communication channel is established during the time window.

29. A system for monitoring an analyte level of a host, configured to perform the method of claim 28, wherein the first communication device comprises a sensor electronics module configured to electronically couple to an analyte sensor and generate an analyte data stream using the analyte sensor.

30. A method for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide a user with access to an analyte value and / or information derived from the analyte value, comprising: Switching a first communication device between a plurality of transmission window states, the plurality of window transmission modes comprising: a first transmission window state, wherein the first communication device does not open a transmission window, a second transmission window state, wherein the first communication device periodically opens a transmission window at a first frequency, and a third transmission window state, wherein the first communications device periodically opens a transmission window at a second frequency less than the first frequency; and One or more beacons are transmitted during each transmission window state.

31. The method of claim 30, wherein the first communications device switches from the first transmission window state to the second transmission window state upon actuation of a Hall effect switch or a reed switch.

32. The method of any of claims 30-31, wherein the first communications device automatically switches from the second transmission window state to the third transmission window state in response to determining that the first communications device and the second communications device are successfully paired.

33. According to the method of any one of claims 30-32, the first communication device automatically switches from the second transmission window state to the third transmission window state in response to determining that pairing has not been successfully completed after a predetermined number of times since switching from the first transmission window state to the second transmission window state.

34. The method of any of claims 30-33, wherein the first frequency is approximately 30 seconds and the second frequency is approximately 5 minutes.

35. A system for monitoring an analyte level of a host, the system being configured to perform the method of any of claims 30-34, wherein a first communication device comprises a sensor electronics module, wherein the sensor electronics module is configured to electronically couple to an analyte sensor and use the analyte sensor to generate an analyte data stream.

36. A method for transmitting data between a first communication device associated with an analyte sensor and a second communication device configured to provide a user with access to an analyte value and / or information derived from the analyte value, the method comprising: storing technical support data in a log file in a memory in the first communication device; determining that a second communication device should receive at least some of the stored technical support data; transmitting, using the first communication device, a message indicating the determination; receiving, from the second communication device in response to the transmitted message, a request for at least some of the stored technical support data; and The at least some of the stored technical support data is transmitted.

37. The method of claim 36, wherein the message is included in a beacon transmitted by the first communications device.

38. The method of any of claims 36-37, wherein the message consists of bits.

39. A system for monitoring an analyte level of a host, configured to perform the method of any of claims 36-38, wherein a first communication device comprises a sensor electronics module, wherein the sensor electronics module is configured to electronically couple to an analyte sensor and use the analyte sensor to generate an analyte data stream.

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