Method and equipment for calculating injection dose of periinsulin preparation

By combining the pharmacokinetic model of peri-insulin preparation and historical injection information, we predict future fasting blood glucose and dynamically adjust the dose to achieve steady state, solving the problem of unscientific calculation of peri-insulin preparation injection dose in the prior art, and improving the effect of blood sugar control and patient compliance.

CN120452672APending Publication Date: 2025-08-08PEKING UNIVERSITY FIRST HOSPITAL (PEKING UNIVERSITY FIRST CLINICAL MEDICAL COLLEGE)
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Patent Information

Application Number
CN202510518678.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-04-24
Publication Date
2025-08-08

AI Technical Summary

Technical Problem

The existing insulin weekly preparation injection dosage calculation methods are insufficient scientific basis, which leads to the fasting blood sugar reaching homeostasis for too long, making it difficult for patients to maintain confidence in continuous treatment, and blood sugar control is not ideal.

Method used

By obtaining the pharmacokinetic model of a single injection of insulin weekly preparation, the patient's historical injection information and fasting blood glucose value, predict fasting blood glucose in the next week, and adjust the dose estimate based on the predicted results until the patient's fasting blood glucose target range is reached, providing a method and equipment for the calculation of the injection dose of weekly preparations of insulin weekly preparations.

Benefits of technology

A more scientific insulin injection dose calculation is achieved, which shortens the time required for the steady-state adjustment process, improves patient compliance and blood sugar control effects, reduces the occurrence of hypoglycemia events, and adapts to irregular injection methods.

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Abstract

The invention discloses a method and equipment for calculating the injection dose of a periinsulin preparation. The method comprises the following steps: acquiring a single injection pharmacokinetic model of the periinsulin preparation, historical injection information of a patient using the periinsulin preparation, a fasting blood glucose value monitored during the period of using the periinsulin preparation by the patient and a dose estimated value of the injection; according to the acquired single injection pharmacokinetic model, the historical injection information, the fasting blood glucose value and the dose estimation value, predicting fasting blood glucose of the patient in a next week after the patient injects the periinsulin preparation according to the dose estimation value; according to whether the fasting blood glucose of the next week is within the fasting blood glucose target range of the patient or not, whether the dose estimation value needs to be adjusted or not is judged, and the dose estimation value is adjusted based on the judgment result so that the adjusted injection dose estimation value can meet the requirement. The injection dosage can enable a patient to reach a steady state as soon as possible, and the injection dosage can be compatible with occasionally irregular injection modes.
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Description

Technical Field

[0001] The present invention relates to the field of insulin infusion control, and in particular to a method and device for calculating the injection dose of a weekly insulin preparation. Background Art

[0002] The first weekly basal insulin formulation, Insulin Ecol, has been approved for the treatment of type 2 diabetes. Clinically, the weekly insulin titration regimen begins with a fixed low dose, then adjusts the next injection dose weekly in 20-unit increments based on fasting blood glucose levels three days prior to the next injection. This process is repeated. The main problem with this approach is that blood glucose levels cannot reach steady-state even after several weeks, requiring such a long time that patients are impatient to continue using the weekly insulin formulation.

[0003] Most of the existing insulin dosage adjustment methods are all carried out based on CGM (Continuous Glucose Monitoring) system. For example, the Chinese patents of Publication No. CN118866223B and Publication No. CN119069105A all provide dosage adjustment of insulin pump or insulin pen through the data of CGM. In addition, the Chinese patent of Publication No. CN119132490A provides a decision-making system for insulin dosage with expert preference learning. However, these methods all relate to one or more insulin injections per day and cannot be applied to a weekly insulin titration regimen. Summary of the Invention

[0004] The main purpose of the present invention is to provide a method and device for calculating the weekly injection dosage of insulin preparations, so as to solve the problems of insufficient scientific basis for calculating the weekly injection dosage of insulin preparations, long time required for the adjustment process of fasting blood glucose to reach steady state, which makes it difficult for patients to maintain confidence in continuous treatment and unsatisfactory blood glucose control.

[0005] The present invention provides a method for calculating the injection dose of an insulin weekly preparation, the method comprising: obtaining a single-injection pharmacokinetic model of the insulin weekly preparation, historical injection information of a patient using the insulin weekly preparation, a fasting blood glucose value monitored during the patient's use of the insulin weekly preparation, and an estimated dose value for this injection; predicting the fasting blood glucose of the patient in the next week after injecting the insulin weekly preparation according to the estimated dose value based on the acquired single-injection pharmacokinetic model, the historical injection information, the fasting blood glucose value, and the estimated dose value; judging whether the estimated dose value needs to be adjusted based on whether the fasting blood glucose in the next week is within the patient's fasting blood glucose target range; if the judgment result is that no adjustment is required, using the estimated dose value as the recommended dose value for this injection; otherwise, adjusting the estimated dose value, and repeating the predicting step, the judging step, and the adjusting step until the judgment result is that no adjustment is required.

[0006] Preferably, the predicting of the patient's fasting blood glucose in the next week after the injection of the weekly insulin preparation according to the estimated dose value based on the acquired single injection pharmacokinetic model, the historical injection information, the fasting blood glucose value and the dose estimate includes: obtaining a historical insulin concentration change function in the patient's body based on the single injection pharmacokinetic model and the historical injection information; obtaining a relationship model between insulin concentration and fasting blood glucose based on the historical insulin concentration change function and the corresponding fasting blood glucose value; and predicting the patient's fasting blood glucose in the next week after the injection of the weekly insulin preparation according to the estimated dose value based on the historical insulin concentration change function, the relationship model between insulin concentration and fasting blood glucose and the dose estimate.

[0007] Preferably, the historical injection information includes the injection time and injection dose of each injection of at least four recent injections of insulin weekly preparations, and obtaining the historical insulin concentration change function in the patient's body based on the single injection pharmacokinetic model and the historical injection information includes: establishing a relationship function between insulin concentration and evaluation time based on the single injection pharmacokinetic model for each injection of insulin weekly preparation according to the injection time and injection dose of each injection in the historical injection information, recorded as a historical single injection insulin concentration change function; linearly superimposing the historical single injection insulin concentration change functions established for each injection of insulin weekly preparation to obtain the historical insulin concentration change function in the patient's body.

[0008] Preferably, the predicting of the patient's fasting blood glucose in the next week after the injection of the insulin weekly preparation according to the estimated dose value based on the historical insulin concentration change function, the relationship model between the insulin concentration and fasting blood glucose, and the estimated dose value includes: obtaining the patient's in vivo insulin concentration change function after the injection of the insulin weekly preparation according to the estimated dose value based on the historical insulin concentration change function and the estimated dose value; and predicting the patient's fasting blood glucose in the next week after the injection of the insulin weekly preparation according to the estimated dose value based on the patient's in vivo insulin concentration change function after the injection of the insulin weekly preparation according to the estimated dose value and the relationship model between the insulin concentration and fasting blood glucose.

[0009] Preferably, obtaining the in vivo insulin concentration change function of the patient after the patient is injected with the insulin weekly preparation according to the estimated dose value based on the historical insulin concentration change function and the estimated dose value includes: establishing a relationship function between insulin concentration and evaluation time based on the single injection pharmacokinetic model for the insulin weekly preparation injected this time according to the estimated dose value, recorded as the insulin concentration change function of this injection; linearly superimposing the historical insulin concentration change function and the insulin concentration change function of this injection to obtain the in vivo insulin concentration change function after the patient is injected with the insulin weekly preparation this time.

[0010] Preferably, the predicting of the fasting blood glucose of the patient in the next week after the injection of the insulin weekly preparation according to the estimated dose value based on the insulin concentration change function in the patient's body after the injection of the insulin weekly preparation according to the estimated dose value and the relationship model between the insulin concentration and the fasting blood glucose includes: obtaining the maximum insulin concentration in the body in the next week and the minimum insulin concentration in the body in the next week based on the insulin concentration change function in the patient's body after the injection of the insulin weekly preparation according to the estimated dose value; and determining the lowest fasting blood glucose corresponding to the maximum insulin concentration in the body in the next week and the highest fasting blood glucose corresponding to the minimum insulin concentration in the body in the next week according to the relationship model between the insulin concentration and the fasting blood glucose.

[0011] Preferably, the step of constructing the relationship model between insulin concentration and fasting blood glucose includes: establishing a corresponding relationship between insulin concentration and fasting blood glucose based on the patient's historical insulin concentration change function and the fasting blood glucose during the injection of the weekly insulin preparation; and constructing a relationship model between insulin concentration and fasting blood glucose based on the established corresponding relationship between insulin concentration and fasting blood glucose.

[0012] Preferably, judging whether the dose estimate needs to be adjusted based on whether the fasting blood glucose in the coming week is within the patient's fasting blood glucose target range includes: when the fasting blood glucose in the coming week is within the patient's fasting blood glucose target range, determining that the dose estimate does not need to be adjusted; otherwise, determining that the dose estimate needs to be adjusted.

[0013] Preferably, the use of the preset safety dose to adjust the dose estimate includes: if the maximum value of the fasting blood glucose in the coming week is greater than the maximum value of the patient's fasting blood glucose target range, then the average value of the dose estimate and the preset safety dose upper limit is determined as the new dose estimate to increase the dose; if the minimum value of the fasting blood glucose in the coming week is less than the minimum value of the patient's fasting blood glucose target range, then the average value of the dose estimate and the preset safety dose lower limit is determined as the new dose estimate to reduce the dose.

[0014] The present invention also provides a device for calculating the weekly injection dose of an insulin preparation, which includes a memory, a processor, and a computer program stored in the memory and runnable on the processor. When the computer program is executed by the processor, the steps of the method for calculating the weekly injection dose of an insulin preparation as described in any one of claims 1 to 9 are implemented.

[0015] The present invention provides a method for calculating the weekly injection dose of insulin preparations and a device capable of implementing the method. These methods comprehensively consider the effects of single-injection pharmacokinetics, historical injections, the current injection, and the like on future fasting blood glucose levels. These methods can more scientifically determine the injection dose suitable for individual patients, enabling them to reach therapeutic steady-state as quickly as possible and shortening the time required for steady-state adjustment. This helps maintain patients' confidence in continued treatment and is compatible with occasionally irregular injection methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a flow chart of a method for calculating the injection dosage of a weekly insulin preparation provided by the present invention;

[0017] Figure 2 This is a detailed flow chart of the method for calculating the weekly insulin formulation injection dosage provided by the present invention;

[0018] Figure 3 This is a schematic diagram of the pharmacokinetic model for a single injection of a weekly insulin formulation;

[0019] Figure 4 This is a schematic diagram of the predicted insulin concentration in a patient's body after injection of a weekly insulin preparation;

[0020] Figure 5 This is a structural block diagram of the insulin weekly preparation injection dosage calculation device provided by the present invention. DETAILED DESCRIPTION

[0021] The embodiments of the present invention are described in detail below with reference to the accompanying drawings. It should be understood that the embodiments described below are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0022] See also Figure 1 The present invention provides a method for calculating the weekly injection dosage of an insulin preparation, the method comprising:

[0023] Step S101: obtaining a single injection pharmacokinetic model of the weekly insulin preparation, historical injection information of the patient using the weekly insulin preparation, fasting blood glucose values monitored during the patient's use of the weekly insulin preparation, and an estimated dose value for this injection.

[0024] Pharmacokinetic models are mathematical tools that describe the dynamic laws of drug absorption, distribution, metabolism, and excretion in the body. The main types include traditional compartment models, physiological pharmacokinetic models (PBPK), pharmacokinetic-pharmacodynamic combined models (PK-PD), population pharmacokinetic models (PopPK), etc. The present invention can select one of these models and determine the model parameters through experiments to obtain a single injection pharmacokinetic model of insulin weekly preparations.

[0025] The half-life of weekly insulin preparations in the human body is relatively long (close to one week). After the weekly insulin preparation is injected at a certain moment, the insulin concentration in the body is not only related to the weekly insulin preparation injected at that moment, but also to the weekly insulin preparations injected several times before that moment. Therefore, the present invention needs to obtain the patient's historical injection information, and the historical injection information includes the injection time and injection dose of each injection of at least four recent injections of weekly insulin preparations.

[0026] The level of insulin concentration in the body directly affects the blood sugar level. If the injection dose at the current moment is too high, the patient may be at risk of hypoglycemia. If the injection dose at the current moment is too low, it will lead to unsatisfactory blood sugar control. In order to obtain a more scientific injection dose faster, the present invention pre-estimates an injection dose as the injection dose at the current moment, which can be called the dose estimate value of this injection. Any value between the preset safety dose lower limit and the preset safety dose upper limit can be used as the dose estimate value of this injection, or the previous injection dose can be used as the dose estimate value of this injection. The present invention does not impose any restrictions on this.

[0027] Step S102: Based on the acquired single injection pharmacokinetic model, the historical injection information, the fasting blood glucose value and the dose estimate, predict the fasting blood glucose value of the patient in the next week after the weekly insulin preparation is injected according to the dose estimate.

[0028] The step S102 includes steps S1021 to S1023, which are specifically as follows:

[0029] Step S1021: Obtaining a historical insulin concentration change function in the patient's body according to the single injection pharmacokinetic model and the historical injection information.

[0030] For a particular injection in the historical injection information, based on the injection time and injection dose of the injection, a relationship function between insulin concentration and evaluation time based on the single injection pharmacokinetic model is established for the insulin weekly preparation injected that time, and this function is recorded as the insulin concentration change function for that injection. In this way, for any injection in the historical injection information, a corresponding single injection insulin concentration change function can be obtained, which for ease of explanation can be referred to as the historical single injection insulin concentration change function. The present invention linearly superimposes the historical single injection insulin concentration change functions established for each injection of the insulin weekly preparation to obtain the historical insulin concentration change function in the patient.

[0031] Furthermore, based on the historical insulin concentration change function in the patient's body, a simulation curve of the insulin concentration change history in the patient's body can be drawn.

[0032] Step S1022: Obtain a relationship model between insulin concentration and fasting blood glucose based on the historical insulin concentration change function and the corresponding fasting blood glucose value.

[0033] Step S1023: Based on the historical insulin concentration change function, the relationship model between the insulin concentration and fasting blood glucose, and the dose estimate, predict the patient's fasting blood glucose in the next week after injecting the weekly insulin preparation according to the dose estimate.

[0034] First, based on the historical insulin concentration change function and the estimated dose value, a function of the patient's in vivo insulin concentration change in the next week after injection of the weekly insulin formulation according to the estimated dose value is obtained. Specifically, based on the estimated dose value, a function of the relationship between insulin concentration and evaluation time based on the single injection pharmacokinetic model is established for the current injection, recorded as the current injection insulin concentration change function, and the historical insulin concentration change function and the current injection insulin concentration change function are linearly superimposed to obtain the in vivo insulin concentration change function after the current injection of the weekly insulin formulation.

[0035] Then, based on the in vivo insulin concentration change function after the current injection of the weekly insulin preparation and the relationship model between the insulin concentration and fasting blood glucose, the patient's fasting blood glucose for the next week after the injection of the weekly insulin preparation according to the estimated dose is predicted. Specifically, based on the in vivo insulin concentration change function after the current injection of the weekly insulin preparation, the maximum in vivo insulin concentration and the minimum in vivo insulin concentration for the next week are obtained, and based on the constructed relationship model between the insulin concentration and fasting blood glucose, the lowest fasting blood glucose corresponding to the maximum in vivo insulin concentration in the next week and the highest fasting blood glucose corresponding to the minimum in vivo insulin concentration in the next week are determined.

[0036] Step S103: Determine whether the estimated dose value needs to be adjusted based on whether the fasting blood glucose in the next week is within the patient's fasting blood glucose target range.

[0037] When the fasting blood glucose in the coming week is within the patient's fasting blood glucose target range, it is determined that the estimated dose value does not need to be adjusted; otherwise, it is determined that the estimated dose value needs to be adjusted.

[0038] Among them, the fasting blood glucose target range of the present invention can be personalized according to factors such as the patient's physical condition, treatment status, etc., so that each patient can have the best plan for himself or herself, and blood glucose control can be more easily met.

[0039] Step S104: If no adjustment is required, the dose estimate is used as the recommended dose value for this injection; if adjustment is required, the dose estimate is adjusted, and the prediction step, the judgment step, and the adjustment step are repeated until the judgment result is that no adjustment is required.

[0040] If the predicted fasting blood glucose values for the next week are all within the patient's fasting blood glucose target range, the dose estimate is generally appropriate, and the dose estimate can be used as the recommended dose for this injection, so that the patient can administer the insulin weekly formulation according to the recommended dose. If at least one of the predicted fasting blood glucose values for the next week is outside the patient's fasting blood glucose target range, specifically, if the maximum value of the predicted fasting blood glucose values for the next week is greater than the maximum value of the patient's fasting blood glucose target range, the dose is increased, for example, by determining the average of the dose estimate and the upper limit of the safe dose as the new dose estimate. If the minimum value of the predicted fasting blood glucose values for the next week is less than the minimum value of the patient's fasting blood glucose target range, the dose is decreased, for example, by determining the average of the dose estimate and the lower limit of the safe dose as the new dose estimate. In actual implementation, the method for adjusting the dose is not limited to the above method; different adjustment steps can also be designed based on the degree to which the fasting blood glucose value exceeds the target range, and the dose estimate can be increased or decreased according to the adjustment step.

[0041] The insulin weekly preparation injection dosage calculation method provided by the present invention carries out the dynamic calculation of this injection dosage (i.e., dosage recommendation) based on the single injection pharmacokinetic model of insulin weekly preparation, the injection time (date or date+moment) of historical injection and injection dosage, makes the patient easy to blood sugar stabilization after this dosage injection insulin weekly preparation, shortens the time required for steady-state adjustment process. In addition, the present invention can introduce the fasting blood sugar measurement record of described patient in the dynamic calculation of this injection dosage, makes described patient more easily reach blood sugar steady state after this dosage injection insulin weekly preparation, further shortens the time required for steady-state adjustment process. In addition, the present invention adapts to irregular injection history, that is, the time interval between adjacent two historical injections is not limited to 7 days (7*24 hours), and interval is 4 days to 6 days, or interval is 8 days to 10 days, and also can apply the method dynamic calculation of this injection dosage of the present invention.

[0042] The difficulty in calculating the injection dose of weekly insulin preparations lies mainly in its relatively long half-life in the human body. Its concentration in the body is not only related to the current injection, but also to the previous injections, which makes it difficult to calculate the maximum concentration of insulin in the human body. If the dosage is not well controlled, it is easy to cause the risk of hypoglycemia. This is also the reason why the titration scheme of weekly preparations currently used in clinical practice is conservative. In order to realize the automatic calculation of the injection dose of weekly insulin preparations and thus achieve blood sugar control as soon as possible, it is necessary to know the amount and time of each insulin injection, and at least 3 fasting blood sugar values during the injection period. The following is combined with Figures 2 to 4 , the method for calculating the injection dose of the insulin weekly preparation of the present invention is described in detail.

[0043] See also Figure 2 The method for calculating the weekly insulin preparation injection dose of the present invention comprises the following steps:

[0044] Step S201: Obtain the injection history of the weekly insulin preparation, the pharmacokinetic model of a single injection of the weekly insulin preparation, and the fasting blood glucose measurement record during the injection of the weekly insulin preparation.

[0045] Record the patient's weekly insulin injection history, including at least the four most recent injections. Each injection record should include the injection time and dose to facilitate dynamic calculation of subsequent injection doses. This can be recorded manually or using application software. The injection time can refer to either the injection date or the injection time on that date.

[0046] The pharmacokinetic model of a single injection of a weekly insulin formulation was obtained experimentally, e.g. Figure 3 shown.

[0047] During the period of weekly insulin injection, fasting blood glucose records are required for at least three times. Fasting blood glucose measurements can be performed before each injection (i.e., on the day of injection) and on the first and second days after the injection, or on the first, second, and third days after each injection. Each fasting blood glucose measurement record should include the fasting blood glucose value and measurement time. The measurement time can refer to the measurement date or the measurement date and specific measurement time.

[0048] Step S202: According to the insulin weekly preparation injection history and the single injection pharmacokinetic model, a simulation curve of the insulin concentration change history in the patient's body is obtained, such as Figure 4 shown.

[0049] Taking the two-compartment model as an example of the pharmacokinetic model for a single injection of weekly insulin, its expression is:

[0050] C insulin =d inject ×(A×e -α·t +B×e -β·t )=d inject ×f(t),t≥0

[0051] Where t is time, t = 0 during injection; A, B, α, β are model coefficients determined by experiments; d inject is the dose of insulin injected; C insulin The concentration of insulin in the body.

[0052] Assume that the current time (i.e. the injection time) is t=0, Indicates that the time before the current time is t i Injected Dose of insulin weekly preparation. It should be noted that here t i A negative number indicates the historical injection time t i Before the current time. Thus, the insulin concentration in the patient's body at time t is:

[0053]

[0054] It can be seen that the above function is the historical insulin concentration change function in the body, which is obtained by linearly superimposing the historical single injection insulin concentration change function. Wherein, i = 1, 2, ..., n. The value of n is an integer greater than or equal to 4. Preferably, n is 4. At this time, only the injection within 4 times the half-life of the insulin is considered. Therefore, for the weekly insulin preparation, only the injection in the last 4 weeks can be considered. In this way, based on the above function, the following can be obtained: Figure 4 The curve before t=0 is shown.

[0055] Step S203: establishing a model between insulin concentration and fasting blood glucose according to the insulin concentration change history curve and the fasting blood glucose value.

[0056] Different modeling methods can be considered here, such as modeling based on the insulin concentration at the time of fasting blood glucose measurement, modeling based on the average insulin concentration X hours before the fasting blood glucose measurement (where X can be 1, 2, 3, 4, 5, 6, 7, 8, etc.), etc.

[0057] For convenience, we assume that fasting blood glucose is measured at 7:00 AM every morning for two consecutive weeks. If a weekly insulin injection is required on that day, a fasting blood glucose measurement is performed before the injection. Thus, the corresponding relationship between insulin concentration and fasting blood glucose can be obtained as shown in Table 1.

[0058] Table 1. Correspondence between insulin concentration and fasting blood glucose

[0059]

[0060]

[0061] Based on the above correspondence, the relationship model between insulin concentration and fasting blood glucose G=g(C insulin ), where G is fasting blood glucose, g(C insulin ) is a function of insulin concentration.

[0062] Step S204: first estimate the insulin dose of this injection. For example, the last injection dose is temporarily set as the insulin dose of this injection. That is, the estimation method is to make the current injection dose consistent with the last injection dose.

[0063] Step S205: Based on the estimated injection dose and the historical change curve, a predicted insulin change curve in the body is obtained, such as Figure 4 The curve shown is after t=0, and the curve in the box is more than one week after t=0.

[0064] The curve acquisition method in this step is basically the same as the curve acquisition method in step S202, and will not be repeated here.

[0065] Step S206: Predicting fasting blood glucose after injection based on the insulin change curve obtained in step S205 and the model between the insulin concentration and fasting blood glucose obtained in step S203.

[0066] For example, the maximum insulin concentration C in the next week starting from the current injection time (t=0) is determined from the insulin change curve obtained in step S205. max and the minimum insulin concentration C min, based on the maximum insulin concentration C in the next week max Get the lowest fasting blood sugar g(C max ) and based on the minimum insulin concentration C in the next week min Get the highest fasting blood glucose g(C min ).

[0067] For another example, fasting blood sugar is calculated based on the integrated results of insulin concentration over a period of time.

[0068] Step S207: Determine whether the predicted fasting blood glucose is within the fasting blood glucose target range. If so, execute step S208; otherwise, execute step S209.

[0069] Step S208: Output the currently estimated injection dose.

[0070] Step S209: Adjust the injection dose to update the injection dose estimated in step S204 with the adjusted injection dose, and repeat the operations of step S205, step S206, and step S207 until the predicted fasting blood glucose is within the fasting blood glucose target range, or the estimated injection dose for this time no longer changes.

[0071] For example, by performing a binary search to update, a safe dose upper limit (d max ) and the lower limit (d min ). Assume that the current estimated injection dose is d n If the dose needs to be increased, the adjusted injection dose is If a dose reduction is required, the adjusted injection dose is The adjusted injection dose is used to update the injection dose in the previous round of calculation step S204.

[0072] See also Figure 5 The present invention also provides an insulin weekly preparation injection dosage calculation device 1, which includes a memory 100, a processor 200, and a computer program stored in the memory 100 and executable on the processor 200. When the computer program is executed by the processor 200, the steps of the above-mentioned insulin weekly preparation injection dosage calculation method can be implemented.

[0073] The method and device for calculating the weekly insulin preparation injection dose of the present invention have the following advantages:

[0074] 1. Make the insulin titration process more stable and increase patient compliance;

[0075] 2. The calculated insulin concentration is more scientifically based, resulting in better blood sugar control and fewer hypoglycemic events;

[0076] 3. Convenient and easy to use, can adapt to irregular injection history.

[0077] Although the present invention has been described in detail above, it is not limited thereto, and those skilled in the art can make various modifications based on the principles of the present invention. Therefore, any modifications made based on the principles of the present invention should be understood to fall within the scope of protection of the present invention.

Claims

1. A method for calculating the weekly injection dose of insulin preparation, characterized in that: The method comprises: Obtain the single-injection pharmacokinetic model of the weekly insulin preparation, the patient's historical injection information of the weekly insulin preparation, the patient's fasting blood glucose value monitored during the use of the weekly insulin preparation, and the estimated dose value of this injection; Predicting the patient's fasting blood glucose level in the next week after injection of the weekly insulin formulation according to the estimated dose based on the acquired single injection pharmacokinetic model, the historical injection information, the fasting blood glucose level, and the estimated dose; determining whether the estimated dose needs to be adjusted based on whether the fasting blood glucose in the next week is within the patient's fasting blood glucose target range; If the judgment result is that no adjustment is required, the dose estimate value is used as the recommended dose value for this injection; otherwise, the dose estimate value is adjusted, and the prediction step, the judgment step, and the adjustment step are repeated until the judgment result is that no adjustment is required.

2. The method according to claim 1, characterized in that The step of predicting the fasting blood glucose level of the patient in the next week after the patient is injected with the weekly insulin preparation according to the estimated dose based on the acquired single injection pharmacokinetic model, the historical injection information, the fasting blood glucose level, and the estimated dose includes: Obtaining a historical insulin concentration change function in the patient according to the single injection pharmacokinetic model and the historical injection information; Obtaining a relationship model between insulin concentration and fasting blood glucose according to the historical insulin concentration change function and the corresponding fasting blood glucose value; Based on the historical insulin concentration change function, the relationship model between the insulin concentration and fasting blood glucose, and the dose estimate, the fasting blood glucose of the patient in the next week after the weekly insulin preparation is injected according to the dose estimate is predicted.

3. The method according to claim 2, characterized in that The historical injection information includes the injection time and injection dose of each injection of at least four recent injections of the weekly insulin preparation. The historical insulin concentration change function obtained in the patient based on the single injection pharmacokinetic model and the historical injection information includes: According to the injection time and injection dose of each injection in the historical injection information, a relationship function between insulin concentration and evaluation time based on the single injection pharmacokinetic model is established for each injection of the weekly insulin preparation, and recorded as a historical single injection insulin concentration change function; The historical single injection insulin concentration change functions established for each injection of the weekly insulin preparation are linearly superimposed to obtain the historical insulin concentration change function in the patient.

4. The method according to claim 2, characterized in that The predicting, based on the historical insulin concentration change function, the relationship model between the insulin concentration and the fasting blood glucose, and the dose estimate, the fasting blood glucose of the patient in the next week after the weekly insulin preparation is injected according to the dose estimate includes: Obtaining, based on the historical insulin concentration change function and the estimated dose value, a function of insulin concentration change in the patient's body after the patient is injected with the weekly insulin preparation according to the estimated dose value; Based on the insulin concentration change function after the patient is injected with the insulin weekly preparation according to the estimated dose value and the relationship model between the insulin concentration and fasting blood glucose, the fasting blood glucose of the patient in the next week after the patient is injected with the insulin weekly preparation according to the estimated dose value is predicted.

5. The method according to claim 4, characterized in that The step of obtaining, based on the historical insulin concentration change function and the estimated dose value, a function of insulin concentration change in the patient's body after the patient is injected with the insulin weekly preparation according to the estimated dose value comprises: According to the estimated dose value, a relationship function between the insulin concentration and the evaluation time based on the single injection pharmacokinetic model is established for the weekly insulin preparation injected this time, and recorded as the insulin concentration change function of this injection; The historical insulin concentration change function and the current insulin concentration change function are linearly superimposed to obtain the in vivo insulin concentration change function after the current injection of the weekly insulin preparation.

6. The method according to claim 4, characterized in that The step of predicting the fasting blood glucose level of the patient in the next week after the patient is injected with the insulin weekly preparation according to the estimated dose based on the insulin concentration change function in the patient's body after the patient is injected with the insulin weekly preparation according to the estimated dose and the relationship model between the insulin concentration and the fasting blood glucose includes: Based on the insulin concentration change function after the patient is injected with the insulin weekly preparation according to the estimated dose value, obtaining the maximum insulin concentration in the body for the next week and the minimum insulin concentration in the body for the next week; According to the relationship model between the insulin concentration and the fasting blood glucose, the lowest fasting blood glucose corresponding to the maximum insulin concentration in the body in the next week and the highest fasting blood glucose corresponding to the minimum insulin concentration in the body in the next week are determined.

7. The method according to any one of claims 1 to 6, characterized in that The determining whether the estimated dose value needs to be adjusted based on whether the fasting blood glucose in the next week is within the patient's fasting blood glucose target range includes: When the fasting blood glucose in the coming week is within the patient's fasting blood glucose target range, it is determined that the estimated dose value does not need to be adjusted; otherwise, it is determined that the estimated dose value needs to be adjusted.

8. The method according to claim 7, characterized in that Said adjusting said dose estimate comprises: If the maximum value of the fasting blood glucose in the coming week is greater than the maximum value of the patient's fasting blood glucose target range, the average of the dose estimate and the preset upper limit of the safe dose is determined as the new dose estimate to increase the dose; If the minimum value of the fasting blood glucose in the next week is less than the minimum value of the patient's fasting blood glucose target range, the average of the dose estimate and the preset safe dose lower limit is determined as the new dose estimate to reduce the dose.

9. A device for calculating the weekly injection dose of an insulin preparation, comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, characterized in that: When the computer program is executed by the processor, the steps of the method for calculating the weekly injection dose of insulin preparation according to any one of claims 1 to 8 are implemented.

Citation Information

Patent Citations

  • AGP intelligent interpretation and insulin adjustment method based on expert system

    CN118866223B

  • Insulin infusion management device, insulin infusion management system and insulin infusion management method

    CN119069105A

  • MDI insulin dose decision-making system with expert preference learning function

    CN119132490A