Continuous analyte monitoring devices and systems having a long-life reusable wireless transmitter unit and application methods therefor

Abstract

This invention relates to a wearable continuous analyte monitoring (CAM) device, comprising a disposable sensor unit and a reusable transmitter unit. The transmitter unit has no power source and has a housing that seals wireless transmitter circuitry within it. The disposable sensor unit is configured to receive and supply power to the transmitter unit. Once the disposable sensor unit expires, the transmitter unit can be removed from the disposable sensor unit and reused with a new power source in another disposable sensor unit. The cover of the CAM device is made of a fabric material to improve the aesthetics and feel of the CAM device. The invention also provides a method for preparing and applying the CAM device to a user's skin, as shown in other embodiments.

Description

[Technical Field]

[0001] This invention relates to an analyte monitoring device, system, and application method thereof. [Previous Technology]

[0002] Continuous Analyte Monitoring (CAM), such as Continuous Glucose Monitoring (CGM), has become a routine monitoring procedure, especially for individuals with diabetes. By providing real-time analyte (e.g., glucose) readings, treatment can be initiated more promptly, and, in the case of CGM, blood glucose levels can be better controlled. The sensors in a CAM device are typically implanted subcutaneously, and the device is attached to the user's skin, for example, on the abdomen or the back of the upper arm. The CAM device can be operated continuously so that the sensors provide periodic signals to a wireless transmitter within the CAM device. These signals indicate the user's analyte (e.g., glucose) levels. A handheld CAM receiver (e.g., a smartphone or other suitable receiver) processes these signals received from the CAM device and displays the analyte readings. Throughout the day, analyte readings can be automatically provided many times (e.g., every few minutes, or at some other pre-established time interval).

[0003] The CAM device may be worn on the body for several days or even weeks before the sensor needs to be removed and replaced. The CAM device may be disposable or reusable. Once the sensor expires, the disposable CAM device should be removed from the user and replaced with a new CAM device. The reusable CAM device typically has a replaceable sensor unit connected to a separate wireless transmitter unit, which typically has a non-replaceable rechargeable battery. Once the sensor expires, the reusable CAM device should be removed from the user, the sensor unit should be replaced with a new sensor unit, and the transmitter unit battery should be charged. Eventually (e.g., after approximately 90 days), the rechargeable battery will no longer be usable, and the entire reusable CAM device will need to be replaced.

[0004] Therefore, an improved reusable CAM device is expected. [Summary of the Invention]

[0005] In some embodiments, the present invention provides a wearable continuous analyte monitoring (CAM) device, comprising a transmitter unit including a housing and a wireless transmitter circuit completely sealed within the housing. The wireless transmitter circuit is operable to receive and wirelessly transmit electronic signals indicating analyte levels. The transmitter unit has no internal power source, and the housing has electrical contacts for receiving power and the electronic signals. The CAM device also includes a sensor unit including a power source and a sensor. The sensor extends through the sensor unit and is configured to be implanted into a user's skin. The sensor unit has a closable opening for receiving the transmitter unit passing through it. The sensor unit is configured to generate the electronic signals indicating the level of an analyte. The sensor unit is also configured to be electrically connected to the electrical contacts of the transmitter unit in response to receiving the transmitter unit through the closable opening. The sensor unit is disposable, and the transmitter unit can be removed from the sensor unit through the closable opening and reused in another sensor unit. The CAM device includes a CAM housing comprising a fabric covering the sensor unit.

[0006] In some embodiments, the present invention provides a method of preparing and applying a continuous analyte monitoring (CAM) device to a user's skin. The method includes inserting a transmitter unit into a sensor unit of the CAM device through an opening, the CAM device being pre-loaded into an applicator. The sensor unit has a sensor extending from the sensor unit and the CAM device. The method also includes closing the opening and attaching a rigid shield to the applicator. The rigid shield has a cap attached thereto. The method further includes removing the cap, positioning the applicator on a surface of the user's skin, and activating the applicator to implant the sensor into the user's skin.

[0007] Other aspects, features, and advantages of the present invention will readily be understood from the following detailed description and illustrations of numerous exemplary embodiments and practices, including the best mode carefully designed to carry out the invention. The invention is also capable of other different embodiments, and certain details may be modified in various ways, all of which remain within the scope of the invention. For example, although the following description relates to CAM and CGM devices, unpowered and long-term reusable transmitter units can also be readily applied to other electronic devices, including disposable and reusable components. All modifications, equivalents, and substitutions are intended to be covered within the scope of the claims.

Implementation Method

[0017] This application claims priority to U.S. Provisional Patent Application No. 63 / 168,196, filed on March 30, 2021, the entire contents of which are incorporated herein by reference for all purposes.

[0018] The embodiments described herein provide a continuous analyte monitoring (CAM) device comprising a disposable sensor unit configured to receive and supply power to a long-term reusable wireless transmitter unit. The transmitter unit includes a housing that completely seals the wireless transmitter circuitry and any other components within it, thereby protecting the transmitter unit from environmental corrosion, exposure, and other factors. The transmitter unit is not equipped with a power source (e.g., a rechargeable battery, which typically has a limited lifespan, e.g., approximately 90 days in some known devices). By providing power within the disposable sensor unit, which in turn powers the transmitter unit, the user avoids the inconvenience of charging the transmitter unit battery each time the disposable sensor unit is replaced (and thus eliminates the need for a separate battery charger, thereby avoiding potential fires or other hazards associated with battery charging). Another advantage is that users receive a new battery along with each new disposable sensor unit, thereby avoiding the risk of power loss due to the transmitter unit battery (which often unexpectedly) no longer has enough power to power the transmitter unit. Therefore, according to the embodiments described herein, the transmitter unit can be reusable for a relatively long period of time (e.g., years rather than months).

[0019] According to the embodiments described herein, the CAM device may also include a cover, which has the advantage of being made of a fabric material to improve the aesthetics, aesthetics, and / or user experience of the CAM device. The appearance of the CAM device can be customized by providing different fabrics and / or colors. In particular, the fabric and color can be selected to mimic the appearance of an adhesive bandage. A fiber web conversion process can be used to manufacture the cover of the fabric material, which reduces manufacturing costs compared to manufacturing covers of conventional CAM devices.

[0020] According to one or more embodiments, a CAM device is provided herein having disposable sensor units configured to receive and power a long-term reusable wireless transmitter unit. Additionally, a CAM device comprising a fabric cover may also be provided herein. The CAM device, system, and application methods of the present invention will be described in more detail below with reference to Figures 1 to 8.

[0021] Figure 1 illustrates a wearable continuous glucose monitoring (CGM) device 100 according to one or more embodiments, which is an example of a CAM device and can be used as part of an analyte (e.g., glucose) measurement system 101. As shown, the CGM device 100 can be attached (via an adhesive) to the skin surface 102S of a user (shown in a partial cross-section). The CGM device and method typically generate an electrochemical analyte (e.g., glucose) signal continuously during operation and perform analyte (e.g., glucose) measurement / estimation based on the periodically generated signal (e.g., typically every few minutes). That is, the CGM device 100 is configured to continuously monitor and provide periodic glucose readings (e.g., every few minutes or other suitable time intervals) to one or more external devices 115 of the analyte (e.g., glucose) measurement system 101.

[0022] The CGM device 100 may include a housing 104 and an adhesive component 106, which together enclose and seal a disposable sensor unit 108 within it. The housing 104 may be made of a soft fabric material and may have a soft and flexible consistency, allowing it to conform to the contours of the user's skin 102. The housing 104 may be flexible, allowing the user to move with limited resistance when an adhesive bandage is applied. In particular, the housing 104 may be made of a thin and flexible woven fabric. The sensor unit 108 may also include a flexible housing 110, wherein the adhesive component 106 may form its bottom surface (i.e., the surface that binds to and attaches to the skin surface 102S).

[0023] A flexible housing 110 and an adhesive component 106 constitute a sensor unit housing 110, which can be removed from the cover 104. In some embodiments, the cover 104 may cover and (e.g.) conformally position itself over the flexible housing 110. The sensor unit 108 may also include a sensor 112 projecting from its bottom end, with a portion of the sensor shown inserted into the user's skin 102. The sensor 112 may extend from the sensor unit 108 and the CGM device 100 via the adhesive component 106 and may be configured to be at least partially positioned in the interstitial fluid within a subcutaneous region of the user. The sensor 112 may be (or may include) an analyte sensor or an analyte sensor component, for example, at or near a sensor tip 112T. The sensor 112 may generate a measurable current when measuring a target analyte (e.g., glucose). The sensor 112 can be inserted using an applicator (i.e., an insertion device 600 as shown in Figures 6A-6E) having a sharp needle or "guide" that pierces the skin 102 to introduce the sensor 112 into the subcutaneous area of ​​the user.

[0024] The sensor unit 108 may also include a removable transmitter unit 114 and a power supply 116. The power supply 116 provides power to the transmitter unit 114, the sensor 112, and (in some embodiments) other sensor circuitry / components (OC / C 117) that may be included in the sensor unit 108. The transmitter unit 114 may include wireless transmitter circuitry and / or other electronic components that communicate with the sensor 112 and / or other sensor circuitry / components 117 to receive electronic signals indicating analyte (e.g., glucose) levels. The transmitter unit 114 may also wirelessly communicate with one or more external devices 115 (e.g., handheld CGM receivers or other portable devices, such as smartphones or watches capable of running a suitable CGM application) to provide blood glucose measurement signals and / or blood glucose measurement results. These one or more external devices 115 may display analyte readings 118 and / or plotted analyte data 119 to display one or more trends. Other information can also be displayed. Although the example depicted is glucose, other analytes (such as lactose or cholesterol) can also be measured, provided that a sensor appropriately selected for those analytes is used.

[0025] Figure 2 illustrates an example of a housing (e.g., housing 104 of Figure 1) of a CAM device according to one or more embodiments. The CAM housing 204 can be made of any suitable soft woven material and is available in a variety of colors. In some embodiments, the CAM housing 204 may be configured to fit snugly over a sensor unit housing (e.g., flexible housing 110). In other embodiments, the CAM housing 204 may be removably attached to a sensor unit, such as sensor unit 108, in any suitable manner. The CAM housing 204 improves the aesthetics, usability, and / or user experience of the CAM device 100 attached to a user, especially compared to conventional CAM devices with rigid housings. The CAM housing 204 may have a low profile relative to its length L. For example, the low profile of the CAM housing, along with the low profile of the CAM device 100 (assuming the thickness of the adhesive component 106 is negligible), can be presented as having a structure in which a length-to-height ratio (L / H ratio) is greater than 4, greater than 6, or even greater than 8 in some embodiments.

[0026] FIG3 illustrates an example of a sensor unit housing according to one or more embodiments, such as the flexible housing 110 of FIG1. ​​The sensor unit housing 310 may include a top 310T and four sides 310S, wherein in some embodiments, an adhesive component (e.g., adhesive component 106) may form a bottom surface (i.e., the surface applied to the user's skin; this bottom surface is not shown in FIG3). That is, the sensor unit housing 310 and the adhesive component 106 may constitute a shell. The sensor unit housing 310 may be made of any suitable flexible material so that the sensor unit housing 310 can bend along the contours of the skin surface when the user walks.

[0027] Figure 4 illustrates a long-term reusable wireless transmitter unit according to one or more embodiments, such as transmitter unit 114 of Figure 1. The transmitter unit 414 is configured to be housed in a sensor unit, such as sensor unit 108 of Figure 1. The transmitter unit 414 may include a housing 414E and a wireless transmitter circuit 414CE (indicated by dashed lines) that can be completely sealed within the housing 414E, thereby protecting the wireless transmitter circuit 414CE from environmental factors. The wireless transmitter circuit 414CE can operate via any suitable wireless protocol and radio communication to receive electronic signals indicating analyte levels and wirelessly transmit them to one or more external devices 115. The transmitter unit 414 does not have an internal power supply. The transmitter unit 414 may include one or more electrical contacts 414C, which can be found on one or more external surfaces of the housing 414E, for receiving power and electronic signals indicating analyte levels. The shape and / or construction of the transmitter unit 414 may differ from those shown in Figures 4 and 8.

[0028] FIG5 shows examples of various components of an adhesive component (e.g., adhesive component 106 of FIG1) according to one or more embodiments. Adhesive component 506 may be used in some embodiments to form the bottom surface of a sensor unit and / or (simultaneously) the bottom surface of a CAM device. "Bottom surface" is defined herein as the surface that will contact the user's skin when the CAM device is attached to the skin surface 102S of the user's skin 102. Adhesive component 506 may include a first peripheral segment 520, a second peripheral segment 522, a hinged adhesive cap 524, a main adhesive segment 526, a removable adhesive backing 528, and a removable adhesive cap backing 530. The adhesives of the hinged adhesive cap 524 and the main adhesive segment 526 are on the same side, suitable for attachment to the skin surface 102S of the user's skin 102. The removable adhesive backing 528 is adjustable in size to cover and protect the adhesive side of the articulated adhesive cap 524 and the main adhesive section 526 until the CAM device is ready to be applied to the skin surface 102S of the user's skin 102. One of the second sides of the articulated adhesive cap 524 may also have adhesive, and the removable adhesive cap backing 530 is also adjustable in size to cover and protect this second side until the CAM device is ready to be applied to the user's skin. Details of this will be described in detail below with reference to Figures 6A-6F.

[0029] In some embodiments, either side of the first peripheral segment 520 and the second peripheral segment 522 may be without adhesive, while in other embodiments, the first peripheral segment 520 and the second peripheral segment 522 may have adhesive suitable for attachment to a skin surface 102S of a user's skin, positioned on the same side as the articulated adhesive cap 524 and the main adhesive segment 526. In those embodiments, the removable adhesive backing 528 may also be resized to cover and protect the first peripheral segment 520 and the second peripheral segment 522. Any suitable adhesive material (e.g., any suitable single-sided or double-sided tape or pressure-sensitive adhesive) and any suitable adhesive backing material may be used for one or more of the first peripheral segment 520, the second peripheral segment 522, the articulated adhesive cap 524, the main adhesive segment 526, the removable adhesive backing 528, and the removable adhesive cap backing 530. Other adhesive components 506 are also possible.

[0030] Figures 6A, 6B, 6C, 6D, 6E, and 6F illustrate a method according to one or more embodiments, comprising various configuration stages to be performed to prepare and apply a CAM device to a user's skin 102. Figure 6A shows an applicator 600 having a CAM device 601 pre-loaded in a body 640 of the applicator 600. The CAM device 601 may be, for example, the CGM device 100 of Figure 1. (Note: The CAM device 601 is shown positioned in the body 640 in Figures 6A-6D, exactly upside down from the position of the CGM device 100 shown in Figure 1.) The applicator 600 also includes a protective cover 642 disposed above a sensor (not shown), which extends from the bottom of a sensor unit of the CAM device 601. A long-term reusable wireless transmitter unit 414 may be inserted into a closable opening 644 of the sensor unit of the CAM device 601.

[0031] As shown in FIG6B, after the transmitter unit 414 is inserted into the sensor unit, a removable adhesive cap backing 630 (which may be similar to or identical to the removable adhesive cap backing 530 of FIG5) can be removed from a hinged adhesive cap 624 (which may be similar to or identical to the hinged adhesive cap 524 of FIG5). After removing the adhesive cap backing 630, the hinged adhesive cap 624 can be sealed over the transmitter unit 414. In this way, the transmitter unit 414 can be airtightly sealed in the closable opening 644.

[0032] In Figure 6C, the assembly of cover 646 and a rigid guard plate 648 can be mounted on the body 640 and positioned above the protective cover 642 and the CAM device 601. Once mounted on the body 640, cover 646 snaps into and is attached to the protective cover 642, while rigid guard plate 648 snaps into and is attached to the body 640 (e.g., by means of a snap-fit ​​action acting above a corresponding ridge 649 along some or all of the periphery of the top of the body 640).

[0033] Figure 6D shows the cover 646 being removed from the body 640, wherein the protective cover 642 and the removable adhesive backing 628 (which may be similar to or identical to the removable adhesive backing 528 of Figure 5) can be removed from the body 640 simultaneously, while the rigid guard plate 648 remains attached to the body 640. In some embodiments, a safety lug 650 may be removed from the applicator 600. The safety lug 650 prevents unintentional activation of the applicator 600 when positioned in the body 640.

[0034] Figure 6E shows the applicator 600 inverted (as shown in Figures 6A-D) and positioned on the surface 102S of a user's skin 102 (partially shown). Specifically, a rigid guard 648 is positioned on and engaged with the user's skin 102. The applicator 600 can then be activated by pressing the body 640 against the skin surface 102S. This action inserts the sensor of the sensor unit of the CAM device 601 subcutaneously into the user's skin 102, similar to or the same as (for example) the operation of the sensor 112 in Figure 1.

[0035] After the applicator 600 is activated, the applicator 600 (especially the main body 640 and the rigid guard plate 648) can be removed, as shown in FIG6F, leaving the CAM device 601 attached to the surface of the user's skin 102. An advantage of the CAM device 601 is that it has a soft and / or fabric cover 604, which may be similar to or identical to the cover 204 in FIG2. Another advantage of the CAM device 601, as shown, is that it has a bandage-like appearance of a common shape (see also FIG2), which (in the plan view) has two parallel long sides and two opposing bullnose (curved, rounded, and faceted) ends, and its length (L) to width (W) aspect ratio (AR) ranges from AR=2:1 to AR=4:1. This appearance can be less noticeable when attached to the user. The CAM device 601 can have a flesh-colored appearance. Therefore, the user avoids the need to explain what "something" is attached to their skin 102, which can be quite embarrassing or awkward for the user.

[0036] FIG7 illustrates a method 700 for preparing and applying a CAM device (e.g., CAM device 601) to a user's skin (e.g., user skin 102) according to one or more embodiments. In block 702, method 700 may begin by inserting a transmitter unit (e.g., a long-term reusable wireless transmitter unit 114, 414) into a sensor unit (e.g., sensor unit 108) of a CAM device (e.g., CAM device 601) through an opening (e.g., a closable opening 644), the transmitter unit being pre-loaded in an applicator (e.g., applicator 600) to attach the CAM device to the user's skin 102. The sensor unit has a sensor (e.g., sensor 112 of FIG1) extending from both the sensor unit and the CAM device. The long-term reusable wireless transmitter unit may be, for example, the wireless transmitter unit 414 shown in FIG6A, which is inserted into the closable opening 644 and into one of the sensor units of the CAM device 601, which is pre-loaded in the applicator 600.

[0037] In some embodiments, the transmitter units 114, 414 may be inserted into a region of the sensor unit 808, which is configured and sized to fit snugly to accommodate the transmitter units 114, 414. For example, FIG8 shows the bottom of a sensor unit 808 according to one or more embodiments, having a region 860 configured to fit snugly to accommodate the transmitter units 114, 414. This shape-matching region 860 ensures that the transmitter units 114, 414, and in particular the electrical contacts 414C, can be properly positioned and electrically connected to the sensor unit 808 to receive power and electronic signals from the sensor unit 808.

[0038] In block 704, method 700 may include closing the closable opening 644 after the transmitter units 114, 414 have been inserted into the sensor unit 808. In some embodiments, the opening may be closed by a hinged cap (e.g., by a hinged adhesive cap 624 in FIG. 6B), which is part of an adhesive component (which forms part of the bottom of the sensor unit and the CAM device). In other embodiments, the closable opening 644 may be closed in any suitable manner and by any suitable structure.

[0039] In block 706, method 700 may include attaching a rigid guard plate to the applicator, wherein the rigid guard plate has a cap attached thereto. For example, as shown in FIG6C, the rigid guard plate may be a rigid guard plate 648, and the cap may be a cap 646 connected thereto.

[0040] In block 708, method 700 may include removing the cap from the applicator, wherein the rigid guard remains attached to the applicator. In some embodiments, for example, the removal of the cap 646 and the security key 650 results in the configuration of the body 640 and the rigid guard 648 of the applicator 600 shown in FIG. 6D.

[0041] In procedure block 710, method 700 may include positioning the applicator on the surface 102S of the user's skin 102 (see, for example, FIG. 6E). Suitable locations may include the user's abdomen or the back of the upper arm.

[0042] In block 712, method 700 may include activating the applicator 600 to insert the sensor (e.g., sensor 112 (FIG. 1)) into the user's skin 102. In some embodiments, the applicator 600 may be activated by pressing the applicator 600 toward the user's skin 102, for example, as indicated in FIG. 6E. After activation, the applicator 600 may be removed, leaving the CAM device 601 attached to the surface 102S of the user's skin 102.

[0043] In some embodiments, after the sensor 112 expires, method 700 may further include multiple procedure blocks (not shown) including: removing the CAM device 601 from the surface 102S of the user's skin 102; removing the transmitter units 114, 414 from the sensor units 108, 808 through the opening 644 (e.g., reversing the procedure shown in Figures 6A and 6B); and reusing the transmitter units 114, 414 in another new sensor unit.

[0044] Although the present invention is susceptible to various modifications and alternatives, embodiments of specific methods and apparatus have been shown by way of example in the drawings and are described in detail herein. However, it should be understood that the specific methods and apparatus disclosed herein are not intended to limit the scope of the present invention or the following claims. [Simplified Explanation of the Diagram]

[0008] The following drawings are for illustrative purposes only and are not necessarily drawn to scale. Therefore, the drawings and descriptions should be considered illustrative rather than restrictive in nature. The drawings are not intended to limit the scope of the invention in any way.

[0009] [Figure 1] is a side view of a continuous glucose monitoring (CGM) device according to an embodiment provided herein, which includes a sensor unit and a transmitter unit housed within the sensor unit.

[0010] [Figure 2] is a perspective view of the housing of a continuous analyte monitoring (CAM) device according to the embodiments provided herein.

[0011] [Figure 3] is a perspective view showing the flexible housing of the sensor unit of the CAM device according to the embodiments provided herein.

[0012] [Figure 4] is a perspective view of a reusable transmitter unit configured to be housed in a sensor unit of a CAM device according to an embodiment provided herein.

[0013] [Figure 5] is an exploded perspective view of the adhesive component of the CAM device according to the embodiments provided herein.

[0014] [Figures 6A, 6B, 6C, 6D, 6E and 6F] are perspective views showing a plurality of steps to be performed in preparing and applying the CAM device to the user’s skin according to the embodiments provided herein.

[0015] [Figure 7] is a flowchart illustrating a method for preparing and applying a CAM device to a user's skin according to an embodiment provided herein.

[0016] [Figure 8] is a perspective view of the bottom of a reusable transmitter unit and a sensor unit of a CAM device according to the embodiments provided herein, wherein a region of the bottom is shaped to accommodate the transmitter unit.

Claims

1. A wearable continuous analyte monitoring (CAM) system, comprising: A CAM device includes: a transmitter unit including a housing and a wireless transmitter circuit completely sealed within the housing, wherein the wireless transmitter circuit is operable to receive and wirelessly transmit electronic signals indicating an analyte level, and the transmitter unit has no internal power supply and has electrical contacts on its housing for receiving power and the electronic signals; a sensor unit including a power supply and a sensor extending through the sensor unit and configured for insertion into a user's skin, wherein the sensor unit has a closable opening for receiving the transmitter unit therethrough, the sensor unit being configured to generate the electronic signals indicating the analyte level and electrically connected to the electrical contacts of the transmitter unit in response to receiving the transmitter unit through the closable opening, wherein the sensor unit is disposable and the transmitter unit can be removed from the sensor unit via the closable opening and can be reused in another sensor unit; a CAM housing including a fabric covering the sensor unit; and an applicator including: A main body configured to house the CAM device therein; a protective cover located above the sensor of the sensor unit housed within the main body; and a rigid guard plate attachable to the main body, wherein the rigid guard plate has a cover connected thereto, and the cover and the protective cover can be removed together after the rigid guard plate is attached to the main body and the CAM device is housed within the main body.

2. The CAM system as described in claim 1, wherein the closable opening includes a hinged cap.

3. The CAM system as claimed in claim 1, wherein the sensor unit further includes an adhesive component having the closable opening, and the sensor extends through the adhesive component.

4. The CAM system as claimed in claim 3, wherein the sensor unit further includes a flexible housing that forms an outer shell with the adhesive component.

5. The CAM system as claimed in claim 1, wherein the sensor unit has a region therein that is shape-matched to receive the transmitter unit.

6. The CAM system as described in claim 1, wherein the CAM device is a continuous glucose monitoring device.

7. The CAM system as claimed in claim 1, comprising a structure of the CAM device, wherein the L / H ratio is greater than 4, wherein the L / H ratio is defined as a length-to-height ratio obtained by dividing the length L by the height H.

8. The CAM system as described in claim 7, which includes an L / H ratio > 6.

9. The CAM system as described in claim 7, which includes an L / H ratio > 8.

10. The CAM system as claimed in claim 1, comprising two parallel sides and two opposing curved ends, wherein AR is from 2:1 to 4:1, wherein AR is the aspect ratio of length (L) to width (W).

11. A CAM system comprising: A CAM device includes: a transmitter unit comprising a housing and a wireless transmitter circuit completely sealed within the housing, wherein the wireless transmitter circuit is operable to receive and wirelessly transmit electronic signals indicating an analyte level, and the transmitter unit has no internal power supply and has electrical contacts on its housing for receiving power and the electronic signals; a sensor unit comprising a power supply and a sensor extending through the sensor unit and configured for insertion into a user's skin, wherein the sensor unit has a closable opening for receiving the transmitter unit therethrough, the sensor unit being configured to generate the electronic signals indicating the analyte level and electrically connected to the electrical contacts of the transmitter unit in response to receiving the transmitter unit through the closable opening, wherein the sensor unit is disposable, and the transmitter unit can be removed from the sensor unit via the closable opening and can be reused in another sensor unit; a CAM The device includes a cover comprising a fabric covering the sensor unit; and an applicator having a body configured to house the CAM device therein, the applicator including a protective shield positioned above the sensor of the sensor unit housed within the body, the applicator further including a rigid guard plate attachable to the body, the CAM device housed within the body, wherein the rigid guard plate has a cover connected thereto, the cover and the protective shield being removable together after the rigid guard plate is attached to the body and the CAM device is housed within the body.

12. A method for preparing and applying a continuous analyte monitoring (CAM) device to the skin of a user, the method comprising: A transmitter unit is inserted through an opening into a sensor unit of a CAM device, which is pre-loaded into an applicator. The transmitter unit includes a housing and a wireless transmitter circuit completely sealed within the housing. The wireless transmitter circuit is operational to receive and wirelessly transmit electronic signals indicating an analyte level. The transmitter unit has no internal power source and has electrical contacts on its housing for receiving power and the electronic signals. The sensor unit includes a power source and a sensor extending through the sensor unit and configured for insertion into a user's skin. The sensor unit has a closable opening to receive the transmitter unit passing through it. The sensor unit is configured to generate the electronic signals indicating the analyte level and is electrically connected to the electrical contacts of the transmitter unit in response to receiving the transmitter unit through the closable opening. The sensor unit is disposable, and the transmitter unit can be removed from the sensor unit via the closable opening and reused in another sensor unit. The CAM device includes a CAM housing comprising a fabric covering the sensor unit. The applicator includes: a body configured to house the CAM device therein; a protective shield positioned above the sensor of the sensor unit housed within the body; and a rigid guard plate attachable to the body, wherein the CAM device is housed within the body. The rigid guard plate has a cap connected thereto, and the cap and the protective shield can be removed together after the rigid guard plate is attached to the body and the CAM device is housed within the body. The applicator then closes the opening; attaches the rigid guard plate to the applicator; removes the cap; positions the applicator on the user's skin; and activates the applicator to insert the sensor into the user's skin.

13. The method as described in claim 12, wherein the step of inserting the transmitter unit includes inserting the transmitter unit into the sensor unit of the CAM device through the opening and into a region of the sensor unit that is shape-matched to receive the transmitter unit.

14. The method as described in claim 12, wherein the step of closing the opening includes sealing a hinged cover of the CAM device over the opening.

15. The method as described in claim 14, wherein the step of closing the opening further includes removing an adhesive cap backing from the hinged cap before sealing the hinged cap.

16. The method as described in claim 12, wherein the step of removing the cover includes removing the cover and removing an adhesive backing from the CAM device.

17. The method as described in claim 12, wherein the step of removing the cover includes removing the cover and a protective shield positioned above the sensor.

18. The method as described in claim 12, wherein the step of activating the applicator further includes attaching the CAM device to the user's skin surface.

19. The method as described in claim 12, further comprising: The CAM device is removed from the user's skin. And remove the transmitter unit from the sensor unit through the opening.

20. The method as described in claim 19 further includes reusing the transmitter unit in another sensor unit.

21. The method as described in claim 12, wherein the CAM device is a continuous glucose monitoring device.

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