Method, system and storage medium for quantitatively measuring insulin sensitivity

By detecting blood sugar concentration in the insulin and glucose solution infusion system and adjusting the infusion rate, the problem of difficult to measure insulin sensitivity is solved, and quantitative evaluation of insulin sensitivity and accurate judgment of insulin efficacy are achieved.

CN112057042BActive Publication Date: 2025-01-10杜少良 +1
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Patent Information

Application Number
CN202010852718.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2020-08-22
Publication Date
2025-01-10
Estimated Expiration
2040-08-22

AI Technical Summary

Technical Problem

The prior art is difficult to accurately measure insulin sensitivity, resulting in insulin resistance that cannot be effectively evaluated, affecting diabetes diagnosis and treatment and basic medical research.

Method used

Using a system including an infusion module, an infusion speed calculation module, a steady-state maintenance module and a sensitivity determination module, the blood sugar concentration is detected by constant infusion of insulin and glucose solutions, the glucose solution infusion speed is adjusted, and the blood sugar concentration is maintained. In the target value range, determine the degree of insulin sensitivity.

Benefits of technology

Quantitative, intuitive and digital evaluation of insulin sensitivity is achieved, and insulin sensitivity can be accurately judged, and indicators for evaluating insulin efficacy are provided.

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Abstract

The present invention relates to a method, system and storage medium for quantitatively measuring insulin sensitivity, which includes: constant infusion of a preset dose of insulin and glucose solution; detection of blood sugar concentration, and calculation and adjustment of the glucose solution infusion rate based on the concentration; maintaining the blood sugar concentration within a preset target value range and maintaining this steady state for a period of time; and determining the sensitivity of insulin by the amount of glucose injection required to maintain the steady state. The present invention divides the human body's glucose capacity into a metabolic amount and a insufficient amount or overflow amount of glucose space, and uses the insufficient amount or overflow amount of glucose space as a feedback condition to correct the metabolic amount calculated in the previous time, so that the blood sugar concentration remains constant, thereby achieving a quantitative, intuitive and digital evaluation of insulin sensitivity.
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Description

Technical Field

[0001] The present invention relates to the field of insulin sensitivity detection, and in particular to a method, system and storage medium for quantitatively measuring insulin sensitivity. Background Art

[0002] Insulin is the only glucose-lowering hormone in the human body, and it also has the function of promoting the synthesis of glycogen, fat, and protein. Under normal physiological conditions, the specific protein expression of insulin molecules can bind to the specific receptors of target cells, thereby activating the glucose transport channel, transporting glucose in the blood to the interior of the cells, and completing the uptake and utilization of glucose by the body cells. At the same time, by promoting glycogen synthesis and inhibiting gluconeogenesis, the purpose of regulating blood sugar is achieved.

[0003] However, under pathological conditions, due to defects in insulin synthesis, the action of autoantibodies or the lack of target cell receptor expression, the biological activity of insulin is lost, and glucose cannot be transported into cells to complete the glucose metabolism process. This pathological phenomenon is called decreased insulin sensitivity or "insulin resistance". Reduced insulin sensitivity will cause glucose to continue to accumulate in the peripheral blood, causing blood sugar to rise; at the same time, due to the stimulation of high blood sugar, the body continues to secrete insulin, leading to hyperinsulinemia. The further development of insulin resistance will lead to systemic disorders in carbohydrate, lipid and protein metabolism, leading to increased risk factors such as cardiovascular, peripheral nerve and kidney diseases.

[0004] Evaluating the degree of insulin resistance or quantifying insulin resistance is of great significance for the later clinical diagnosis and treatment of diabetes, basic medical research, and drug development. However, insulin resistance is a physiological phenomenon that cannot be accurately measured by conventional biochemical methods. How to evaluate insulin sensitivity using intuitive digital methods has become a technical problem that needs to be solved urgently. Summary of the invention

[0005] In view of the above problems, the purpose of the present invention is to provide a method, system and storage medium for quantitatively measuring insulin sensitivity, which can achieve quantitative and intuitive evaluation of insulin sensitivity using digitalization.

[0006] To achieve the above-mentioned purpose, the first implementation mode adopted by the present invention is: a system for quantitatively measuring insulin sensitivity, which includes: an infusion module, an infusion rate calculation module, a steady-state maintenance module and a sensitivity determination module; the infusion module is used to constantly infuse a preset dose of insulin and a glucose solution; the infusion rate calculation module detects the blood glucose concentration and calculates and adjusts the glucose solution infusion rate based on it; the steady-state maintenance module maintains the blood glucose concentration within a preset target value range and maintains this steady state for a period of time; the sensitivity determination module determines the sensitivity of insulin by the amount of glucose injection required to maintain the steady state.

[0007] Furthermore, in the infusion rate calculation module, the blood glucose concentration is detected every 5 minutes; when adjusting the infusion rate, the insufficient amount or overflow amount of the glucose space is used as a feedback condition to correct the metabolic amount calculated last time, so that the blood glucose concentration is kept constant.

[0008] Furthermore, in the infusion speed calculation module, the formula for calculating the infusion speed of the glucose solution based on the blood sugar concentration is:

[0009]

[0010] In the formula, Ginf is the infusion rate of glucose solution, in mL / 60min, and is the metabolic amount of glucose; Ginf i2 Glucose infusion rate 10 minutes ago, unit: mL / 60min; G d is the preset target blood glucose concentration, in mg / dL; G i is the current blood glucose concentration, in mg / dL, Kg is the subject's weight, in Kg; G i1 is the previous blood glucose concentration.

[0011] Furthermore, in the sensitivity determination module, the method for determining the sensitivity of insulin by the amount of glucose injection required to maintain steady state is: if the steady-state glucose infusion rate GIR is greater than the normal reference value of the steady-state glucose infusion rate, the insulin sensitivity is normal; otherwise, the body is insensitive to insulin or the insulin efficacy is poor, and insulin resistance exists.

[0012] Furthermore, the system also includes an infusion rate calculation module for calculating the glucose infusion rate during the steady-state period.

[0013] Furthermore, in the infusion rate calculation module, it is assumed that the start and end time of the steady-state period is 90-120 minutes, which is calculated as T 90 -T 120 , the corresponding glucose solution infusion rate is Ginf 90 and Ginf 120; If the concentration of glucose solution is 20%, then the steady-state glucose infusion rate GIR is:

[0014]

[0015] Among them, G mg It is the total milligrams of glucose infused within 90-120 minutes; the unit of steady-state glucose infusion rate GIR is mg / Kg / min.

[0016] Furthermore, the system also includes a determination condition setting module for setting the determination condition of insulin sensitivity.

[0017] Further, in the determination condition setting module, the three determination conditions are:

[0018] (1) Steady state of blood glucose concentration: During the steady state period, blood glucose concentration should be maintained at the target blood glucose concentration G d Within ±0.5mmol / L;

[0019] (2) Steady state of plasma insulin concentration: During the steady state period, the plasma insulin concentration is maintained at 80-120 mU / L;

[0020] (3) C-peptide level: During the steady-state period, the plasma C-peptide level should not be higher than the C-peptide level in the basal state.

[0021] The second implementation mode adopted by the present invention is: a method for quantitatively measuring insulin sensitivity, which comprises the following steps: constantly infusing a preset dose of insulin and infusing a glucose solution; detecting the blood glucose concentration and calculating and adjusting the glucose solution infusion rate based on it; maintaining the blood glucose concentration within a preset target value range and maintaining this steady state for a period of time; and determining the insulin sensitivity by the amount of glucose injection required to maintain the steady state.

[0022] Furthermore, the blood glucose concentration is tested every 5 minutes; when adjusting the infusion rate, the insufficient or overflow amount of the glucose space is used as a feedback condition to correct the metabolic amount calculated last time, so that the blood glucose concentration is kept constant.

[0023] Furthermore, the formula for calculating the infusion rate of glucose solution based on blood sugar concentration is:

[0024]

[0025] In the formula, Ginf is the infusion rate of glucose solution, in mL / 60min, and is the metabolic amount of glucose; Ginf i2 Glucose infusion rate 10 minutes ago, unit: mL / 60min; G d is the preset target blood glucose concentration, in mg / dL; G iis the current blood glucose concentration, in mg / dL, Kg is the subject's weight, in Kg; G i1 is the previous blood glucose concentration.

[0026] Furthermore, the method of determining insulin sensitivity based on the amount of glucose injection required to maintain steady state is: if the steady-state glucose infusion rate GIR is greater than the normal reference value of the steady-state glucose infusion rate, the insulin sensitivity is normal; otherwise, the body is insensitive to insulin or the insulin efficacy is poor, and insulin resistance exists.

[0027] Furthermore, the method also includes a step of calculating the glucose infusion rate during the steady state period.

[0028] Furthermore, assuming that the start and end time of the steady-state period is 90-120 minutes, calculated as T 90 -T 120 , the corresponding glucose solution infusion rate is Ginf 90 and Ginf 120 ; If the concentration of glucose solution is 20%, then the steady-state glucose infusion rate GIR is:

[0029]

[0030] Among them, G mg It is the total milligrams of glucose infused within 90-120 minutes; the unit of steady-state glucose infusion rate GIR is mg / Kg / min.

[0031] Furthermore, the method further includes the step of setting conditions for determining insulin sensitivity.

[0032] Furthermore, the sensitivity of insulin is determined based on the amount of glucose injection required to maintain steady state, and the following three determination conditions must be met at the same time:

[0033] (1) Steady state of blood glucose concentration: During the steady state period, blood glucose concentration should be maintained at the target blood glucose concentration G d Within ±0.5mmol / L;

[0034] (2) Steady state of plasma insulin concentration: During the steady state period, the plasma insulin concentration is maintained at 80-120 mU / L;

[0035] (3) C-peptide level: During the steady-state period, the plasma C-peptide level should not be higher than the C-peptide level in the basal state.

[0036] A third embodiment of the present invention is: a computer-readable storage medium having computer program instructions stored thereon, wherein the program instructions are used to implement the steps corresponding to the method described in the second embodiment when executed by a processor.

[0037] The fourth embodiment of the present invention is: a computer device, comprising: one or more processors, a memory and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, and the one or more programs include instructions for executing any of the methods described in the second embodiment above.

[0038] The present invention has the following advantages due to the adoption of the above technical scheme: the present invention divides the glucose capacity of the human body into the metabolic capacity and the insufficient or overflow amount of the glucose space, and uses the insufficient or overflow amount of the glucose space as a feedback condition to correct the metabolic capacity calculated in the previous time, so that the blood glucose concentration remains constant. Moreover, under the premise of giving a constant dose of exogenous insulin, the amount of exogenous glucose infusion when the blood glucose concentration reaches a steady state can be used as an evaluation index of insulin sensitivity or insulin efficacy. A quantitative, intuitive, and digital evaluation of insulin sensitivity is achieved. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 Schematic diagram of the insulin sensitivity detection principle in an embodiment of the present invention. DETAILED DESCRIPTION

[0040] In order to make the purpose, technical solution and advantages of the embodiment of the present invention clearer, the technical solution of the embodiment of the present invention will be clearly and completely described below in conjunction with the drawings of the embodiment of the present invention. Obviously, the described embodiment is a part of the embodiment of the present invention, not all of the embodiments. Based on the described embodiment of the present invention, all other embodiments obtained by ordinary technicians in this field belong to the scope of protection of the present invention.

[0041] The present invention provides a method for quantitatively measuring insulin sensitivity, which uses an experimental method to evaluate insulin sensitivity. Figure 1 As shown, the present invention comprises the following steps:

[0042] A constant infusion of pre-set doses of insulin was given, along with an infusion of glucose solution;

[0043] Detect blood sugar concentration and use it to calculate and adjust the glucose solution infusion rate;

[0044] Maintain blood glucose concentration within a pre-set target range for a period of time; at this time, the amount of glucose metabolism mediated by insulin is equal to the amount of glucose infused exogenously;

[0045] Insulin sensitivity is determined by the amount of glucose infusion required to maintain steady state.

[0046] In a preferred embodiment, the concentration of the glucose solution is 20%, that is, it is prepared from 20 g of glucose and 100 mL of normal saline.

[0047] In a preferred embodiment, the blood glucose concentration is preferably detected every 5 minutes. When adjusting the infusion rate, the insufficient amount or overflow amount of the glucose space is used as a feedback condition to correct the metabolic amount calculated last time (i.e., the last 5 minutes) to keep the blood glucose concentration constant.

[0048] In a preferred embodiment, the preset target value range is about 4.5-5 mmol / L (90 mg / dL), but does not exceed 5 mmol / L.

[0049] In a preferred embodiment, the steady state time can be set to 30-40 minutes. Since the injected glucose can be completely mixed with the glucose space in about 30 minutes, the steady state time is preferably 30 minutes.

[0050] In a preferred embodiment, the formula for calculating the infusion rate of the glucose solution based on the blood glucose concentration is:

[0051] Ginf=F c ×Ginf i2 +GS, (1)

[0052] In the formula, Ginf is the infusion rate of glucose solution (unit: mL / 60min), which is the metabolic amount of glucose; Ginf i2 is the glucose infusion rate 10 minutes ago, which is approximately the glucose metabolism in 10 minutes (unit: mL / 60 min); GS is the overflow or shortage of glucose space (unit: mg, but in the calculation of GS, it needs to be converted into the increase or decrease of the glucose infusion rate in the next five minutes); F c It is the cumulative error coefficient, which is used to correct the glucose infusion rate to avoid the situation where the glucose infusion rate may be continuously low.

[0053] In the above embodiment, the calculation method of GS is: Assuming that the current blood glucose concentration is higher than the set target value, it means that the glucose infusion rate Ginf 10 minutes ago is i2 If the glucose infusion rate is greater than the glucose metabolism rate mediated by insulin, glucose will accumulate in the blood, resulting in an increase in blood glucose concentration. On the contrary, if the glucose infusion rate is less than the current glucose metabolism rate, glucose in the blood will be continuously transferred to the target cells, resulting in a decrease in blood glucose concentration. The calculation formula of GS is:

[0054]

[0055] In the formula, G d is the preset target blood glucose concentration (mg / dL); Gi is the current blood glucose concentration (mg / dL); Kg is the subject's weight (in Kg).

[0056] In the above embodiment, F c The calculation formula is:

[0057]

[0058] In the formula, G i1 It is the blood glucose concentration 5 minutes ago (previous time).

[0059] Substituting equations (2) and (3) into equation (1), the complete glucose infusion rate calculation formula is:

[0060]

[0061] In a preferred embodiment, the method for determining the sensitivity of insulin by the amount of glucose injection required to maintain steady state is: if the steady-state glucose infusion rate GIR is greater than the normal reference value of the steady-state glucose infusion rate, the insulin sensitivity is normal; otherwise, the body is insensitive to insulin or the insulin efficacy is poor, and "insulin resistance" exists.

[0062] The above embodiment also includes a step of calculating the glucose infusion rate during the steady state period. Specifically, the glucose infusion rate is the number of milligrams of glucose metabolized per kilogram of body weight per minute by the subject.

[0063] Assume that the start and end time of the steady-state period is 90-120 minutes, which is calculated as T 90 -T 120 The corresponding glucose solution infusion rate is Ginf 90 and Ginf 120 The concentration of glucose solution is known to be 20%. By calculation, the total number of milligrams of glucose input within 90-120 minutes can be obtained, which is G mg The steady-state glucose infusion rate GIR is:

[0064]

[0065] The unit of steady-state glucose infusion rate GIR is mg / Kg / min.

[0066] Among them, the number of milligrams of glucose per 5 minutes is G mg1 for:

[0067] G mg1 =200(mg / mL)×5min×Ginf(mL / 60min) / 60=200×Ginf / 12(mg)

[0068] Since each time interval is 5 minutes, the total number of milligrams of glucose is G mg for:

[0069] G mg=200×Ginf 90 / 12+200×Ginf 95 / 12+200×Ginf 100 / 12+…+200×Ginf 120 / 12

[0070] =50×(Ginf 90 +Ginf 95 +Ginf 100 +…+Ginf 120 )÷3.

[0071] Preferably, the normal reference value of the steady-state glucose infusion rate is: 6.286 mg × Kg -1 ×min -1 ; The determination method is: the lower quartile of the mean of the measurement results defined by WHO is used as the cut-off point.

[0072] The above embodiment also includes the step of setting insulin sensitivity determination conditions. The insulin sensitivity is determined according to the glucose injection amount required to maintain steady state. The following three determination conditions must be met at the same time, and then the insulin sensitivity determination result is accurate.

[0073] The three judgment conditions are:

[0074] (1) Steady state of blood glucose concentration: During the steady state period, blood glucose concentration should be maintained at the target blood glucose concentration G d Within ±0.5mmol / L. If the fluctuation is too large, it may be suspected that there are interference factors and the judgment result is unreliable.

[0075] (2) Steady state of plasma insulin concentration: During the steady state period, the plasma insulin concentration is maintained at 80-120 mU / L. If the plasma insulin concentration is too low, it may lead to endogenous insulin secretion, interfering with the determination results; if the plasma insulin concentration is too high, it may increase non-insulin-dependent glucose uptake, which will also affect the determination results.

[0076] (3) C-peptide level: During the steady-state period, the plasma C-peptide level should not be higher than the C-peptide level at baseline. Otherwise, it indicates that the patient's own insulin is secreted during the test and the result is unreliable.

[0077] Embodiment 1:

[0078] In this embodiment, inanimate human or animal bodies, or ex vivo tissues are used as test subjects. The specific measurement method is as follows:

[0079] 1. Prepare 1000 ml of 20% glucose solution and set aside.

[0080] 2. Prepare insulin solution according to the subject's weight and maintenance time at an infusion rate of 2mU / Kg / Min.

[0081] Preparation method:

[0082] Assume the subject's weight is: 65Kg; the test duration is 150 minutes

[0083] To offset the decrease in concentration caused by insulin adsorption in the infusion line, the amount of insulin is increased by 20%. The required amount of insulin is:

[0084] 1.2×(2×65×150) / 1000=23.4IU

[0085] Dissolve 23.4 IU of short-acting insulin in a syringe filled with 50 mL of normal saline and mix thoroughly.

[0086] 3. Inject insulin solution at an injection rate of 2mU / Kg / Min for 10 minutes, and maintain this injection rate until the end of the experiment to allow the plasma insulin concentration to reach a steady state. This injection rate can quickly establish a dominant exogenous plasma insulin concentration. At this injection rate, it is expected that a dominant plasma insulin concentration of 80-120mU / L can be achieved.

[0087] 4. 10 minutes after the injection of insulin solution, measure the plasma blood glucose concentration every 5 minutes and calculate the infusion rate of glucose solution based on this blood glucose concentration.

[0088] 5. According to the blood glucose concentration measured every 5 minutes, use the infusion rate calculation formula in the above steps to calculate the new glucose solution infusion rate, adjust the infusion rate according to the new glucose solution infusion rate, and repeat this operation until the end of the experiment. At the same time, record the time, blood glucose concentration, glucose solution infusion rate and other parameters of each blood glucose test point.

[0089] 6. When the blood glucose concentration remains steady for about 30 minutes, the experiment can be ended. During this steady-state period, all exogenous glucose input is metabolized by insulin. Therefore, the glucose infusion rate during the steady-state period can reflect insulin sensitivity or the biological efficacy of insulin.

[0090] In the above steps, since the insulin sensitivity determination method takes about 2 hours, and the insulin efficacy evaluation may take 8-24 hours. Therefore, the experimenter's operation method, patient compliance, and insulin properties all have an impact on the measurement results. In this embodiment, it is recommended that each laboratory establish an internal normal reference value. The recommended normal reference value for insulin sensitivity is: 6.286 mg × Kg -1 ×min -1 (The lower quartile of the mean of the test results defined by WHO is used as the cut-off point).

[0091] The present invention also provides a system for quantitatively measuring insulin sensitivity, which uses an experimental method to evaluate insulin sensitivity. The present invention includes an infusion module, an infusion speed calculation module, a steady-state maintenance module and a sensitivity determination module. Among them:

[0092] The infusion module is used to constantly infuse a pre-set dose of insulin and to infuse a glucose solution;

[0093] The infusion speed calculation module detects the blood sugar concentration and uses it to calculate and adjust the glucose solution infusion speed;

[0094] The steady-state maintenance module maintains the blood glucose concentration within the preset target value range and maintains this steady state for a period of time; at this time, the amount of glucose metabolism mediated by insulin is equal to the amount of glucose infused exogenously;

[0095] The sensitivity determination module determines the insulin sensitivity by the amount of glucose injection required to maintain steady state.

[0096] In the above embodiment, the concentration of the glucose solution is 20%, that is, it is prepared from 20 g of glucose and 100 mL of normal saline.

[0097] In the above embodiment, in the infusion rate calculation module, the blood glucose concentration is preferably detected every 5 minutes. When adjusting the infusion rate, the metabolic amount calculated last time (i.e., last 5 minutes) is corrected based on the insufficient amount or overflow amount of the glucose space as a feedback condition to keep the blood glucose concentration constant.

[0098] In the above embodiment, in the infusion rate calculation module, the formula for calculating the infusion rate of the glucose solution based on the blood sugar concentration is:

[0099] Ginf=F c ×Ginf i2 +GS,

[0100] In the formula, Ginf is the infusion rate of glucose solution (unit: mL / 60min), which is the metabolic amount of glucose; Ginf i2 is the glucose infusion rate 10 minutes ago, which is approximately the glucose metabolism in 10 minutes (unit: mL / 60 min); GS is the overflow or shortage of glucose space (unit: mg, which needs to be converted into the increase or decrease of the glucose infusion rate in the next 5 minutes in the calculation); F c It is the cumulative error coefficient, which is used to correct the glucose infusion rate to avoid the situation where the glucose infusion rate may be continuously low.

[0101] In the above embodiment, the calculation method of GS is: Assuming that the current blood glucose concentration is higher than the set target value, it means that the glucose infusion rate Ginf 10 minutes ago is i2If the glucose infusion rate is greater than the glucose metabolism rate mediated by insulin, glucose will accumulate in the blood, resulting in an increase in blood glucose concentration. On the contrary, if the glucose infusion rate is less than the current glucose metabolism rate, glucose in the blood will be continuously transferred to the target cells, resulting in a decrease in blood glucose concentration. The calculation formula of GS is:

[0102]

[0103] In the formula, G d is the preset target blood glucose concentration (mg / dL); G i is the current blood glucose concentration (mg / dL); Kg is the subject's weight (in Kg).

[0104] In the above embodiment, F c The calculation formula is:

[0105]

[0106] In the formula, G i1 It is the blood glucose concentration 5 minutes ago (previous time).

[0107] F c Substituting the GS formula into the above infusion rate formula, the complete glucose infusion rate calculation formula is obtained:

[0108]

[0109] In a preferred embodiment, in the sensitivity determination module, the method for determining the sensitivity of insulin by the amount of glucose injection required to maintain steady state is: if the steady-state glucose infusion rate GIR is greater than the normal reference value of the steady-state glucose infusion rate, the insulin sensitivity is normal; otherwise, the body is insensitive to insulin or the insulin efficacy is poor, and "insulin resistance" exists.

[0110] The above embodiment also includes an infusion rate calculation module for calculating the glucose infusion rate during the steady state period. Specifically, the glucose infusion rate is the number of milligrams of glucose metabolized per kilogram of body weight per minute by the subject.

[0111] Assume that the start and end time of the steady-state period is 90-120 minutes, which is calculated as T 90 -T 120 The corresponding glucose solution infusion rate is Ginf 90 and Ginf 120 The concentration of glucose solution is known to be 20%. By calculation, the total number of milligrams of glucose input within 90-120 minutes can be obtained, which is G mg The steady-state glucose infusion rate GIR is:

[0112]

[0113] The unit of steady-state glucose infusion rate GIR is mg / Kg / min.

[0114] Among them, the number of milligrams of glucose per 5 minutes is G mg1 for:

[0115] G mg1 =200(mg / mL)×5min×Ginf(mL / 60min) / 60=200×Ginf / 12(mg)

[0116] Since each time interval is 5 minutes, the total number of milligrams of glucose is G mg for:

[0117] G mg =200×Ginf 90 / 12+200×Ginf 95 / 12+200×Ginf 100 / 12+…+200×Ginf 120 / 12

[0118] =50×(Ginf 90 +Ginf 95 +Ginf 100 +…+Ginf 120 )÷3.

[0119] Preferably, the normal reference value of the steady-state glucose infusion rate is: 6.286 mg × Kg -1 ×min -1 ; The determination method is: the lower quartile of the mean of the measurement results defined by WHO is used as the cut-off point.

[0120] The above embodiment also includes a determination condition setting module for setting the determination condition of insulin sensitivity. The insulin sensitivity is determined according to the glucose injection amount required to maintain steady state. The following three determination conditions must be met at the same time, and then the insulin sensitivity determination result is accurate.

[0121] The three judgment conditions are:

[0122] (1) Steady state of blood glucose concentration: During the steady state period, blood glucose concentration should be maintained at the target blood glucose concentration G d Within ±0.5mmol / L. If the fluctuation is too large, it may be suspected that there are interference factors and the judgment result is unreliable.

[0123] (2) Steady state of plasma insulin concentration: During the steady state period, the plasma insulin concentration is maintained at 80-120 mU / L. If the plasma insulin concentration is too low, it may lead to endogenous insulin secretion, interfering with the determination results; if the plasma insulin concentration is too high, it may increase non-insulin-dependent glucose uptake, which will also affect the determination results.

[0124] (3) C-peptide level: During the steady-state period, the plasma C-peptide level should not be higher than the C-peptide level at baseline. Otherwise, it indicates that the patient's own insulin is secreted during the test and the result is unreliable.

[0125] The present invention also provides a computer-readable storage medium on which computer program instructions are stored. When the program instructions are executed by a processor, the steps of any data storage method provided in the above embodiments of the present invention are implemented.

[0126] In this embodiment, the present invention further provides a computer program, which includes computer program instructions, and when the program instructions are executed by a processor, they are used to implement the steps of any data storage method provided by the above embodiments of the present invention.

[0127] In the above embodiments, the computer-readable storage medium and the computer program are used to implement the corresponding data storage method in the above method embodiments, and have the beneficial effects of the corresponding method embodiments, which will not be described in detail here.

[0128] In summary, when the present invention is used, the glucose capacity of the human body is divided into the metabolic capacity and the insufficient or overflow amount of the glucose space. The insufficient or overflow amount of the glucose space is used as a feedback condition to correct the metabolic capacity calculated last time, so that the blood glucose concentration is kept constant. Moreover, under the premise of giving a constant dose of exogenous insulin, the amount of exogenous glucose infusion when the blood glucose concentration reaches a steady state can be used as an evaluation index of insulin sensitivity or insulin efficacy.

[0129] Furthermore, under the premise of one-time (non-constant) administration of exogenous insulin, the glucose infusion curve when the blood glucose concentration is always maintained relatively constant is used as an evaluation indicator of insulin bioefficacy.

[0130] It should be pointed out that, according to the needs of implementation, the various components / steps described in the embodiments of the present invention can be split into more components / steps, or two or more components / steps or partial operations of components / steps can be combined into new components / steps to achieve the purpose of the embodiments of the present invention.

[0131] The above-described method according to an embodiment of the present invention may be implemented in hardware, firmware, or as software or computer code that may be stored in a recording medium (such as a CD ROM, RAM, floppy disk, hard disk, or magneto-optical disk), or as computer code that is originally stored in a remote recording medium or a non-temporary machine-readable medium downloaded over a network and will be stored in a local recording medium, so that the method described herein may be stored in such software processing on a recording medium using a general-purpose computer, a dedicated processor, or programmable or dedicated hardware (such as an ASIC or FPGA). It is understood that a computer, a processor, a microprocessor controller, or programmable hardware includes a storage component (e.g., RAM, ROM, flash memory, etc.) that can store or receive software or computer code, and when the software or computer code is accessed and executed by a computer, a processor, or hardware, the processing method described herein is implemented. In addition, when a general-purpose computer accesses the code for implementing the processing shown herein, the execution of the code converts the general-purpose computer into a dedicated computer for executing the processing shown herein.

[0132] Those skilled in the art will appreciate that the units and method steps of each example described in conjunction with the above disclosed embodiments can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel can use different methods to implement the described functions for each specific application, but such implementation should not be considered to be beyond the scope of the embodiments of the present invention.

[0133] The above implementation methods are only used to illustrate the embodiments of the present invention, and are not limitations of the embodiments of the present invention. Ordinary technicians in the relevant technical field may make various changes and modifications without departing from the spirit and scope of the embodiments of the present invention. Therefore, all equivalent technical solutions also belong to the scope of the embodiments of the present invention. The patent protection scope of the embodiments of the present invention should be defined by the claims.

Claims

1. A system for quantitatively measuring insulin sensitivity, characterized in that: include: Infusion module, infusion rate calculation module, steady-state maintenance module and sensitivity determination module; The infusion module is used to constantly infuse a preset dose of insulin and infuse a glucose solution; The infusion speed calculation module detects the blood sugar concentration and calculates and adjusts the glucose solution infusion speed based on it; The steady-state maintenance module maintains the blood glucose concentration within a preset target value range and maintains this steady state for a period of time; The sensitivity determination module determines the sensitivity of insulin by the amount of glucose injection required to maintain steady state; The formula for calculating the infusion rate of glucose solution based on blood glucose concentration is: Ginf=F c ×Ginf i2 +GS, In the formula, Ginf is the infusion rate of glucose solution, in mL / 60min, and Ginf is the metabolic amount of glucose; i2 Glucose infusion rate 10 minutes ago, unit: mL / 60min; G d is the preset target blood glucose concentration, in mg / dL; G i is the current blood glucose concentration, in mg / dL, Kg is the subject's weight, in Kg; G i1 is the previous blood glucose concentration; GS is the overflow or deficiency of glucose space, in mg; F c It is the cumulative error coefficient, which is used to correct the glucose infusion rate to avoid the situation where the glucose infusion rate may be continuously low; The calculation method of GS is: Assuming that the current blood glucose concentration is higher than the set target value, it means that the glucose infusion rate Ginf 10 minutes ago is i2 If the amount of glucose infusion is greater than the rate of glucose metabolism mediated by insulin, glucose will accumulate in the blood, causing the blood glucose concentration to rise. On the contrary, if the amount of glucose infusion is less than the current amount of glucose metabolism, glucose in the blood will be continuously transferred to the target cells, causing the blood glucose concentration to drop. Blood glucose concentration is tested every 5 minutes. When adjusting the infusion rate, the glucose capacity of the human body is divided into the metabolic capacity and the insufficient or overflow amount of glucose space. The insufficient or overflow amount of glucose space is used as a feedback condition to correct the metabolic capacity calculated last time, so that the blood glucose concentration remains constant. Moreover, under the premise of giving a constant dose of exogenous insulin, the amount of exogenous glucose infusion when the blood glucose concentration reaches a steady state is used as an evaluation indicator of insulin sensitivity or insulin efficacy. Under the premise of non-constant administration of exogenous insulin, the glucose infusion curve that always maintains a relatively constant blood glucose concentration is used as an evaluation indicator of insulin bioefficacy.

2. The system according to claim 1, characterized in that: In the sensitivity determination module, the method for determining the sensitivity of insulin by the amount of glucose injection required to maintain steady state is: if the steady-state glucose infusion rate GIR is greater than the normal reference value of the steady-state glucose infusion rate, the insulin sensitivity is normal; otherwise, the body is insensitive to insulin or the insulin efficacy is poor, and insulin resistance exists.

3. The system according to claim 2, characterized in that: The system further comprises an infusion rate calculation module for calculating the glucose infusion rate during the steady state period.

4. The system according to claim 3, characterized in that: In the infusion rate calculation module, it is assumed that the start and end time of the steady-state period is 90-120 minutes, which is calculated as T 90 -T 120 , the corresponding glucose solution infusion rate is Ginf 90 and Ginf 120 ; If the concentration of glucose solution is 20%, then the steady-state glucose infusion rate GIR is: Among them, G mg It is the total milligrams of glucose infused within 90-120 minutes; the unit of steady-state glucose infusion rate GIR is mg / Kg / min.

5. The system according to claim 1, characterized in that: The system also includes a determination condition setting module, which is used to set the determination condition of insulin sensitivity.

6. The system according to claim 5, characterized in that: In the determination condition setting module, the three determination conditions are: (1) Steady state of blood glucose concentration: During the steady state period, blood glucose concentration should be maintained at the target blood glucose concentration G d Within ±0.5mmol / L; (2) Steady state of plasma insulin concentration: During the steady state period, the plasma insulin concentration is maintained at 80-120 mU / L; (3) C-peptide level: During the steady-state period, the plasma C-peptide level should not be higher than the C-peptide level in the basal state.

Citation Information

Patent Citations

  • Modular blood glucose regulating system

    CN106730153A