Real-time adjusting method for insulin infusion amount and closed-loop infusion system

Abstract

The invention discloses a real-time adjusting method for insulin infusion volume, which adopts a closed-loop control method, and dynamically adjusts the infusion volume of an insulin pump based on a comparison result of a predicted blood glucose parameter and a preset blood glucose range through collected blood glucose data and predicted future blood glucose data, thereby realizing more accurate blood glucose control. The invention further discloses a closed-loop infusion system designed based on the real-time adjustment method. The closed-loop infusion system comprises a controller, a blood glucose detection system, an insulin pump and a continuous glucose monitoring system. Compared with open-loop control, the closed-loop control can monitor the blood glucose level of the patient in real time and automatically adjust the insulin infusion amount according to real-time data, and the high-automation system can more accurately maintain the blood glucose within the target range and reduce blood glucose fluctuation. Moreover, the closed-loop control system reduces the requirements of patients or medical staff for manually calculating and adjusting the insulin dosage, so that personal errors are reduced, automatic adjustment can better adapt to individual differences and dynamic changes of the patients, the burden of the patients on blood glucose monitoring and insulin dosage adjustment is reduced, and the safety and effectiveness of treatment are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of insulin infusion control, and particularly to a method for real-time adjustment of insulin infusion amount and an infusion system. Background Art

[0002] With the continuous increase in the number of global diabetes patients, diabetes has become the third major chronic disease seriously threatening human health after tumors and cardiovascular diseases. At present, medical technology has not been able to cure diabetes, and most patients can only rely on insulin injection to control the condition. Traditional treatment methods simulate the normal insulin secretion mode of the human body, inject insulin for patients to maintain the stability of blood glucose level and manage blood glucose.

[0003] Currently, most diabetes patients rely on insulin pumps for treatment, and maintain blood glucose stability by infusing insulin regularly and quantitatively. However, due to the combined effects of various factors such as individual differences, diet, exercise, and emotions, the blood glucose level of patients is in dynamic change. This makes it difficult to accurately match the insulin infusion dose with the actual demand, resulting in poor blood glucose control effect. In addition, when using an insulin pump by themselves, patients often encounter the dilemma of frequent and fluctuating blood glucose levels, which not only increases the risk of hyperglycemia, but also may induce other complications, seriously affecting the quality of life of patients.

[0004] Based on this, it is necessary to invent a method and system that can automatically adjust the insulin infusion amount of an insulin pump in real time. Summary of the Invention

[0005] In order to overcome the technical problem in the above-mentioned prior art that it is difficult to accurately match the insulin infusion dose with the actual demand due to various factors, the present invention provides a method for real-time adjustment of insulin infusion amount and a closed-loop infusion system.

[0006] The technical solution adopted by the present invention to solve its problems is as follows:

[0007] A method for real-time adjustment of insulin infusion amount, the method includes the following steps:

[0008] S1. Set a preset blood glucose range, and obtain the first blood glucose parameter of the human body at intervals;

[0009] Among them, the preset blood glucose range is not a fixed value for each user, and the user can set it according to their actual physical condition; within the interval time, the first blood glucose parameter can be collected multiple times. If it is collected multiple times, the last collected first blood glucose parameter shall prevail.

[0010] S2. Continuously obtain the second blood glucose parameter of the human body regularly according to the first preset time, and perform calibration calculation on the second blood glucose parameter with the first blood glucose parameter as the standard value to obtain a calibrated blood glucose parameter;

[0011] The calibrated blood glucose parameters obtained through the above calibration operation can more accurately reflect the current blood glucose level, help the system calculate the insulin demand more precisely, significantly improve the accuracy of blood glucose monitoring, reduce error accumulation, and thus better guide the adjustment of insulin dosage, reducing hyperglycemic or hypoglycemic events in patients with hyperglycemia, etc.;

[0012] S3. Predict the first predicted blood glucose parameter within a subsequent third preset time according to the trend change of the calibrated blood glucose parameters within a past second preset time and the currently obtained calibrated blood glucose parameters;

[0013] By using methods such as moving average or difference to smooth the data and extract the trend, the change trend of blood glucose (i.e., calibrated blood glucose parameters) within a past second preset time can be analyzed, including patterns such as rising, falling, or stable, obtaining features related to blood glucose changes, and thus predicting the blood glucose level (i.e., the first predicted blood glucose parameter) within a future period of time;

[0014] S4. Obtain the remaining insulin amount of the human body according to the insulin infusion amount within a past second preset time, and predict the second predicted blood glucose parameter within a subsequent third preset time according to the remaining insulin amount and the currently obtained calibrated blood glucose parameters;

[0015] The remaining insulin amount of the human body can be calculated through the active insulin percentage-time curve, and then according to the remaining insulin amount and the current blood glucose (i.e., calibrated blood glucose parameters), the decrease amount of blood glucose value within a third preset time can be predicted, so as to obtain the second predicted blood glucose parameter;

[0016] S5. Obtain the third predicted blood glucose parameter according to the first predicted blood glucose parameter and the second predicted blood glucose parameter, and compare the third predicted blood glucose parameter with a preset blood glucose range;

[0017] Among them, the third predicted blood glucose parameter is the finally predicted blood glucose value. Through the predicted blood glucose value, on the one hand, the possible rising trend of blood glucose can be discovered in advance, especially in the case of after meals or insufficient insulin dosage. This can help patients adjust their diet, increase exercise, or adjust insulin dosage in a timely manner to avoid the occurrence of hyperglycemia; on the other hand, the possible falling trend of blood glucose can be discovered in advance, and measures (such as supplementing carbohydrates) can be taken in a timely manner to avoid the occurrence of hypoglycemic events.

[0018] S6. Control the insulin infusion amount of the insulin pump according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range;

[0019] The preset blood glucose range is set according to the individual conditions of the patient. For example, the blood glucose target range for adult diabetic patients may be set to 3.9 - 10.0 mmol / L. Through the above control method, the infusion volume of the insulin pump can be dynamically adjusted based on the comparison result between the finally predicted blood glucose parameter and the preset blood glucose range, so as to achieve more precise blood glucose control.

[0020] In the technical solution of the present invention, the second preset time needs to be greater than the first preset time to ensure that the blood glucose parameter collected through the first preset time is within the second preset time, so as to obtain the trend change of the blood glucose parameter; the second preset time needs to be greater than or equal to the third preset time to ensure that the blood glucose parameter is estimated within the obtained historical blood glucose data range, ensuring the reliability and accuracy of the prediction value.

[0021] As a preferred technical solution, controlling the insulin infusion volume of the insulin pump according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range specifically includes:

[0022] S601. Set a first target blood glucose value within the preset blood glucose range;

[0023] Among them, the first target blood glucose value is a fixed value within the preset blood glucose range, usually located at or around the middle value of the preset blood glucose range, which is the key to further realizing precise blood glucose management and is used to ensure the balance of blood glucose control. For example, if the blood glucose target range for adult diabetic patients is set to 3.9 - 10.0 mmol / L, the first target blood glucose value can be set to 5.5 mmol / L, 6.1 mmol / L or 6.7 mmol / L.

[0024] S602. When the third predicted blood glucose parameter is within the preset blood glucose range, compare the third predicted blood glucose parameter with the first target blood glucose value;

[0025] S603. When the third predicted blood glucose parameter is less than the first target blood glucose value, control the insulin pump to reduce the basal infusion rate of insulin to the first basal infusion rate according to the difference between the third predicted blood glucose parameter and the first target blood glucose value;

[0026] For the above difference, if the third predicted blood glucose parameter is lower than the first target blood glucose value, the deviation value is negative;

[0027] S604. When the third predicted blood glucose parameter is greater than the first target blood glucose value, control the insulin pump to increase the basal infusion rate of insulin to the second basal infusion rate according to the difference between the third predicted blood glucose parameter and the first target blood glucose value.

[0028] For the above difference, if the third predicted blood glucose parameter is higher than the first target blood glucose value, the deviation value is positive;

[0029] The above process reflects the high automation and intelligence of a closed-loop system, and its main purpose is to prevent the occurrence of hypoglycemia while ensuring that the human blood glucose is maintained within the target range.

[0030] As a preferred technical solution, the control of the insulin pump to reduce the basal infusion rate of insulin to a first basal infusion rate and the control of the insulin pump to increase the basal infusion rate of insulin to a second basal infusion rate specifically include:

[0031] S605. Obtain the total daily insulin amount of the human body and calculate the numerical amount of the total daily basal rate of the human body according to the total daily insulin amount;

[0032] S606. Calculate the average daily basal rate of the human body according to the numerical amount of the total daily basal rate;

[0033] S607. Calculate the target basal infusion rate of the insulin pump according to the average daily basal rate, and the target basal infusion rate is the first basal infusion rate or the second basal infusion rate.

[0034] Through the above steps, the target basal infusion rate of the insulin pump can be calculated and set according to the total daily insulin amount of the patient, so as to achieve more accurate blood glucose control.

[0035] As a preferred technical solution, the control of the insulin infusion amount of the insulin pump according to the comparison result of the third predicted blood glucose parameter and the preset blood glucose range specifically further includes:

[0036] S611. When the third predicted blood glucose parameter is outside the preset blood glucose range, compare the third predicted blood glucose parameter with the upper limit value and the lower limit value of the preset blood glucose range;

[0037] S612. When the third predicted blood glucose parameter is less than the lower limit value of the preset blood glucose range, control the insulin pump to reduce the insulin infusion amount to zero;

[0038] S613. When the third predicted blood glucose parameter is greater than the upper limit value of the preset blood glucose range, control the insulin pump to infuse a micro-large dose within a fourth preset time.

[0039] When it is predicted that the blood glucose level will exceed the target range, infusing a micro-large dose (SMB) can quickly provide the required insulin to quickly reduce the blood glucose level and reduce blood glucose fluctuations. Compared with changing the basal injection rate, the micro-large dose (SMB) can provide the required insulin earlier, thus reducing the blood glucose faster and effectively preventing postprandial hyperglycemia, etc.

[0040] As a preferred technical solution, the control of the insulin infusion amount of the insulin pump according to the comparison result of the third predicted blood glucose parameter and the preset blood glucose range specifically further includes:

[0041] S614. When the third predicted blood glucose parameter is less than the lower limit of the preset blood glucose range, control the insulin pump to issue an alarm prompt;

[0042] Through the above steps, it is possible to effectively control the insulin pump to timely adjust the bolus dose during meals when the third predicted blood glucose parameter is higher than the preset range, thereby better managing blood glucose levels.

[0043] As a preferred technical solution, calibrating the second blood glucose parameter with the first blood glucose parameter as the standard value to obtain a calibrated blood glucose parameter specifically includes:

[0044] S21. Initially collect the second blood glucose parameter and calculate the difference between the initially collected second blood glucose parameter and the first blood glucose parameter;

[0045] S22. According to the difference, perform offset calibration on the subsequently collected second blood glucose parameters.

[0046] If the difference is positive, the subsequent data needs to subtract this difference; if the difference is negative, this difference needs to be added; by correcting the blood glucose data, the accuracy of blood glucose monitoring can be improved.

[0047] As a preferred technical solution, obtaining the third predicted blood glucose parameter based on the first predicted blood glucose parameter and the second predicted blood glucose parameter specifically includes:

[0048] S51. Take the average value of the first predicted blood glucose parameter and the second predicted blood glucose parameter to obtain the third predicted blood glucose parameter.

[0049] Through the above method, different prediction models (blood glucose parameter trend prediction and human insulin amount prediction) can be comprehensively considered to obtain a more accurate blood glucose prediction value, thereby better guiding the adjustment of insulin infusion amount.

[0050] As a preferred technical solution, the real-time adjustment method of insulin infusion amount further includes the following steps:

[0051] S7. Real-time obtain the insulin infusion data of the insulin pump, and control the insulin infusion amount of the insulin pump according to the insulin infusion data and the calibrated blood glucose parameter or the third predicted blood glucose parameter.

[0052] The obtained insulin infusion data can be uploaded to the insulin management system or other systems. Doctors or diabetes educators can view the real-time status of each patient through the system. Based on these monitoring data, it is helpful to timely adjust the treatment plan and improve the accuracy and safety of blood glucose control.

[0053] Based on the same design concept, the present invention also provides a closed-loop infusion system, which includes a controller, a blood glucose detection system, an insulin pump, and a continuous glucose monitoring system. The controller is electrically connected to the insulin pump, and the insulin pump is electrically connected to the continuous glucose monitoring system.

[0054] The above-mentioned controller, blood glucose detection system, insulin pump, and continuous glucose monitoring system are combined to form an integrated closed-loop blood glucose management system. The system combines blood glucose monitoring, insulin infusion, and automatic control functions to more precisely manage the blood glucose level of diabetic patients.

[0055] Among them, the blood glucose detection system is used to obtain the first blood glucose parameter of the human body at intervals and send the first blood glucose parameter to the controller; the controller is used to send a start instruction to the insulin pump and send the first blood glucose parameter to the insulin pump; the continuous glucose monitoring system is used to obtain the second blood glucose parameter of the human body in real time and send the second blood glucose parameter to the insulin pump; the insulin pump is used to infuse insulin for the human body according to the first blood glucose parameter and the second blood glucose parameter, and send the insulin infusion data to the controller.

[0056] As a preferred technical solution, the closed-loop infusion system further includes a computer and a cloud platform. The cloud platform is electrically connected to the computer and the controller respectively.

[0057] The above-mentioned computer and cloud platform are further combined to form an integrated closed-loop blood glucose management system. Through the collaborative work of the cloud platform, controller, and computer, the intelligent and remote management of insulin infusion is realized, significantly improving the blood glucose control effect and quality of life of diabetic patients.

[0058] Among them, the cloud platform is used to send a start instruction to the controller and receive the insulin infusion data of the controller; the computer is used to send a start instruction to the cloud platform and receive the insulin infusion data of the cloud platform.

[0059] In summary, compared with the prior art, the method for real-time adjustment of insulin infusion amount and the closed-loop infusion system provided by the present invention have at least the following technical effects:

[0060] The above real-time adjustment method of insulin infusion volume constitutes a closed-loop control system. Compared with open-loop control, the present invention can monitor the patient's blood glucose level in real time and automatically adjust the insulin infusion volume according to the real-time data. Such a highly automated system can more accurately maintain blood glucose within the target range and reduce blood glucose fluctuations. Moreover, the closed-loop control system reduces the need for patients or medical staff to manually calculate and adjust insulin doses, thereby reducing human errors. The automated adjustment can better adapt to individual patient differences and dynamic changes, reducing the burden on patients for blood glucose monitoring and insulin dose adjustment, and improving the safety and effectiveness of treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] Figure 1 It is a schematic flowchart of the real-time adjustment method of insulin infusion volume of the present invention;

[0062] Figure 2 It is the first schematic diagram of the closed-loop infusion system of the present invention;

[0063] Figure 3 It is the second schematic diagram of the closed-loop infusion system of the present invention;

[0064] Figure 4 It is the third schematic diagram of the closed-loop infusion system of the present invention;

[0065] Figure 5 It is the fourth schematic diagram of the closed-loop infusion system of the present invention;

[0066] Figure 6 It is a schematic diagram of the curve of the decrease of active insulin in the body over time; DETAILED DESCRIPTION OF THE EMBODIMENTS

[0067] For better understanding and implementation, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

[0068] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention.

[0069] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which the present invention belongs. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0070] See Figure 1 As shown, in the technical solution of the present invention, the method for real-time adjustment of insulin infusion amount includes the following steps:

[0071] S1. Set a preset blood glucose range, which is not a fixed value for each user, and the user can set it according to their actual physical condition. Intermittently obtain the first blood glucose parameter of the human body, and the interval time can be 1 - 5 days, but is not limited to 1 - 5 days.

[0072] Optionally, within the interval time, the first blood glucose parameter can be collected multiple times. If collected multiple times, the last collected first blood glucose parameter shall prevail.

[0073] S2. Continuously obtain the second blood glucose parameter of the human body at regular intervals according to the first preset time, and calibrate and calculate the second blood glucose parameter with the first blood glucose parameter as the standard value to obtain a calibrated blood glucose parameter. This step is used to calibrate the continuously obtained second blood glucose parameter. The obtained calibrated blood glucose parameter can more accurately reflect the current blood glucose level, help the system calculate the insulin demand more precisely, significantly improve the accuracy of blood glucose monitoring, reduce error accumulation, so as to better guide the adjustment of insulin dosage and reduce hyperglycemic or hypoglycemic events in patients with hyperglycemia, etc.

[0074] S3. Predict the first predicted blood glucose parameter within the subsequent third preset time according to the trend change of the calibrated blood glucose parameter within the past second preset time and the currently obtained calibrated blood glucose parameter. This step is used to predict the future blood glucose of the human body. Specifically, the moving average or difference method can be used to smooth the data and extract the trend, analyze the change trend of the calibrated blood glucose parameter within the past second preset time, including patterns such as rising, falling or stable, obtain the characteristics related to blood glucose change, so as to predict the blood glucose level within a certain period of time in the future, that is, the first predicted blood glucose parameter.

[0075] Of course, the present invention can also improve the prediction accuracy by combining a machine learning model to analyze the trend change of the calibrated blood glucose parameter within a certain period of time. For example, the GluFormer model using the Transformer architecture can process continuous calibrated blood glucose parameters to predict future blood glucose levels. This model can capture complex blood glucose dynamic changes and provide more accurate predictions.

[0076] It is worth mentioning that the second preset time needs to be greater than the first preset time to ensure that the second blood glucose parameter collected through the first preset time is within the second preset time, so as to obtain the trend change of the second blood glucose parameter within the second preset time.

[0077] S4. Obtain the remaining insulin amount in the human body according to the insulin infusion amount in the past second preset time, and predict the second predicted blood glucose parameter in the subsequent third preset time according to the remaining insulin amount and the currently obtained corrected blood glucose parameter. Optionally, the present invention can calculate the remaining insulin amount in the human body through the active insulin percentage-time curve, and then predict the decrease amount of the blood glucose value in the third preset time according to the remaining insulin amount and the currently obtained corrected blood glucose parameter, so as to obtain the second predicted blood glucose parameter.

[0078] Optionally, refer to the article "Insulin Aspart (B28Asp-Insulin) A Fast-Acting Analog of Human Insulin" by Mudaliar and his colleagues (DIABETES CARE, VOLUME 22, NUMBER 9, SEPTEMBER 1999, page 1501) to obtain Figure 6 the active insulin percentage-time curve shown.

[0079] It is worth mentioning that the second preset time needs to be greater than or equal to the third preset time to ensure that the blood glucose parameter is estimated within the time range where the obtained historical blood glucose data is located, and to ensure the reliability and accuracy of the prediction value.

[0080] S5. Obtain the third predicted blood glucose parameter according to the first predicted blood glucose parameter and the second predicted blood glucose parameter, and compare the third predicted blood glucose parameter with the preset blood glucose range. Among them, the third predicted blood glucose parameter obtained in this step is the finally predicted blood glucose value. Through this finally predicted blood glucose value, on the one hand, it can be used to detect in advance the possible upward trend of blood glucose, especially in the case of after meals or insufficient insulin dosage. This can help patients adjust their diet, increase exercise or adjust insulin dosage in a timely manner to avoid the occurrence of hyperglycemia; on the other hand, it can detect in advance the possible downward trend of blood glucose and take timely measures (such as supplementing carbohydrates) to avoid the occurrence of hypoglycemic events.

[0081] S6. Control the insulin infusion amount of the insulin pump according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range. Specifically, the preset blood glucose range in this step is set according to the individual conditions of different patients. For example, the blood glucose target range for adult diabetic patients may be set to 3.9-10.0 mmol / L. Through the above control method, the infusion amount of the insulin pump can be dynamically adjusted based on the comparison result between the finally predicted blood glucose parameter and the preset blood glucose range, so as to achieve more accurate blood glucose control.

[0082] Therefore, based on the above solution, the real-time adjustment method of the insulin infusion amount of the present invention constitutes a closed-loop control method, which can monitor the blood glucose level of patients in real time and automatically adjust the insulin infusion amount according to the real-time data. Such a highly automated system can more accurately maintain blood glucose within the target range and reduce blood glucose fluctuations. Moreover, the closed-loop control system reduces the need for patients or medical staff to manually calculate and adjust insulin doses, thereby reducing human errors. The automated adjustment can better adapt to individual patient differences and dynamic changes, reduce the burden on patients for blood glucose monitoring and insulin dose adjustment, and improve the safety and effectiveness of treatment.

[0083] See Figures 2 - 5 As shown, based on the same design concept, the present invention also provides a closed-loop infusion system, which includes a controller 100, a blood glucose detection system 105, an insulin pump 101, and a continuous glucose monitoring system 102. The controller 100 is electrically connected to the insulin pump 101, and the insulin pump 101 is electrically connected to the continuous glucose monitoring system 102.

[0084] Specifically, the blood glucose detection system 105 is used to intermittently obtain the first blood glucose parameter of the human body 103 and send the first blood glucose parameter it obtains to the controller 100. At the same time, the controller 100 is used to send a start instruction for closed-loop control to the insulin pump 100, and send the first blood glucose parameter it obtains to the insulin pump 100, thereby completing step S1 of the above closed-loop control method.

[0085] After starting the closed-loop control method, the continuous glucose monitoring system 102 is used to obtain the second blood glucose parameter of the human body 103 in real time and send the second blood glucose parameter it obtains to the insulin pump 101. At the same time, the insulin pump 101 is used to infuse insulin for the human body 103 according to the first blood glucose parameter and the second blood glucose parameter it obtains, thereby completing steps S2 - S6 of the above closed-loop control method.

[0086] In addition, the insulin pump 101 is also used to send insulin infusion data to the controller 100 for data feedback for monitoring. Therefore, the closed-loop infusion system combines blood glucose monitoring, insulin infusion, and automatic control functions, and can be used to more accurately manage the blood glucose level of diabetic patients.

[0087] Furthermore, see Figure 2 and Figure 4 As shown, the closed-loop infusion system of the present invention further includes a computer 99 and a cloud platform 104. The cloud platform 104 is electrically connected to the computer 99 and the controller 100 respectively. Among them, the cloud platform 104 is used to send a start instruction to the controller 100 and receive the insulin infusion data of the controller 100; the computer 99 is used to send a start instruction to the cloud platform 104 and receive the insulin infusion data of the cloud platform 104.

[0088] Optionally, the controller described in this solution can be any one of a mobile controller, a smart phone, and a smart watch, but is not limited to the above solution.

[0089] Embodiment 1

[0090] See Figure 2 As shown, the first optional embodiment of the present invention provides a technical solution on how to start closed-loop control, how to perform closed-loop control, and how to monitor closed-loop control of the closed-loop infusion system of the present invention.

[0091] See Figure 2 As shown, the computer 99 sends a start instruction through the cloud platform 104, and the controller 100 forwards the instruction received from the cloud platform 104. After the insulin pump 101 receives the start instruction from the controller 100, it enters the closed-loop control mode.

[0092] Optionally, the controller 100 is provided with a Bluetooth, WIFI communication, or 4G network interface, and realizes information transmission with the insulin pump 101 by means of wireless data transmission.

[0093] See Figure 2 As shown, after entering the closed-loop control mode, the insulin pump 101 calibrates and calculates the second blood glucose parameter of the glucose monitoring system 102 based on the first blood glucose parameter sent by the continuous blood glucose detection system 105 to obtain a calibrated blood glucose parameter.

[0094] Moreover, the insulin pump 101 predicts the first predicted blood glucose parameter within the subsequent third preset time according to the trend change of the calibrated blood glucose parameter within the past second preset time and the currently obtained calibrated blood glucose parameter.

[0095] Meanwhile, the insulin pump 101 obtains the remaining insulin amount of the human body according to the insulin infusion amount within the past second preset time, and predicts the second predicted blood glucose parameter within the subsequent third preset time according to the remaining insulin amount and the currently obtained calibrated blood glucose parameter.

[0096] Finally, the insulin pump 101 compares the third predicted blood glucose parameter obtained from the first predicted blood glucose parameter and the second predicted blood glucose parameter with the preset blood glucose range, and controls the insulin infusion amount of the insulin pump 101 according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range.

[0097] Optionally, the first preset time in the above solution can be 3 - 5 minutes, the second preset time can be 10 - 30 minutes, the third preset time can be 10 - 30 minutes, and both the second preset time and the third preset time are preferably 20 minutes.

[0098] Further, the insulin pump 101 will calculate the amount of insulin to be infused. By controlling the DC motor, the rotation of the motor drives the push rod to move forward, and the push rod pushes the liquid medicine in the medicine reservoir through the pipeline to be connected to the human body 103. Finally, the insulin enters the human body 103 to achieve the effect of blood sugar control.

[0099] Optionally, the insulin pump 101 includes a processor, which can be used to implement operations such as data storage, calculation, and control.

[0100] At the same time, after starting the closed-loop control, the insulin pump 101 uploads the real-time insulin infusion data to the controller 100 through Bluetooth, WIFI, or 4G network, etc., and then transmits it to the computer 99 through the controller 100 and the cloud 104.

[0101] Embodiment 2

[0102] See Figure 3 As shown, the second optional embodiment of the present invention provides another technical solution on how to start the closed-loop control, how to perform the closed-loop control, and how to monitor the closed-loop control of the closed-loop infusion system of the present invention.

[0103] See Figure 3 As shown, the controller 100 directly sends a start instruction. After the insulin pump 101 receives the start instruction from the controller 100, it enters the closed-loop control mode.

[0104] After entering the closed-loop control mode, the methods for blood sugar prediction and insulin infusion amount control of the insulin pump 101 for the human body 103 are the same as those in the above embodiments, and will not be elaborated here.

[0105] At the same time, after starting the closed-loop control, the insulin pump 101 uploads the real-time insulin infusion data to the controller 100 through Bluetooth, WIFI, or 4G network, etc.

[0106] Embodiment 3

[0107] See Figure 4 As shown, the third optional embodiment of the present invention provides a technical solution on how to obtain the first blood sugar parameter of the closed-loop infusion system of the present invention.

[0108] See Figure 4As shown, after the operator activates the closed-loop control mode, the blood glucose detection system 105 squeezes the blood collected from the patient's fingertip 106 into the test strip and waits for a few seconds for the blood glucose detection system 105 to display the blood glucose reading (i.e., the first blood glucose parameter). The doctor, nurse, or user inputs the blood glucose reading into the computer and sends it to the controller 100 through the cloud platform 104. The controller 100 sends the received first blood glucose parameter to the insulin pump 101 via Bluetooth, WIFI, or 4G network. The insulin pump 101 stores the received blood glucose reading in its processor memory and uses it as the standard value for blood glucose data.

[0109] Subsequently, the continuous glucose monitoring system 102 sends the second blood glucose parameter at intervals of 1 minute, 5 minutes, or other times to the insulin pump 101 via Bluetooth, WIFI, or 4G network. The insulin pump 101 stores the received second blood glucose parameter in the processor memory, performs calibration calculations with the previous standard value (i.e., the first blood glucose parameter), and stores it in the processor memory.

[0110] Embodiment 4

[0111] See Figure 5 As shown, the fourth alternative embodiment of the present invention provides another technical solution for how the closed-loop infusion system of the present invention obtains the first blood glucose parameter.

[0112] See Figure 4 As shown, after the operator activates the closed-loop control mode, first, the blood glucose detection system 105 is used to collect the blood glucose at the fingertip 106, and the blood glucose reading measured by the blood glucose detection system 105 is input into the controller 100. The controller 100 sends the first blood glucose parameter via Bluetooth, WIFI, or 4G network. After receiving the first blood glucose parameter, the insulin pump 101 stores it in its processor memory and uses this blood glucose reading as the algorithm standard value.

[0113] Subsequently, the calibration method of the insulin pump 101 for the second blood glucose parameter is the same as that in the above embodiment and will not be elaborated here.

[0114] Based on the above four embodiment solutions, the present invention further refines the method for real-time adjustment of the insulin infusion amount, as follows.

[0115] In step S6, according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range, the insulin infusion amount of the insulin pump is controlled, which specifically includes the following steps:

[0116] S601. Set the first target blood glucose value within a preset blood glucose range. The first target blood glucose value is a fixed value within the preset blood glucose range, usually located at the middle value of the preset blood glucose range, which is the key to further achieving precise blood glucose management and is used to ensure the balance of blood glucose control. For example, if the blood glucose target range for adult diabetic patients is set to 3.9 - 10.0 mmol / L, the first target blood glucose value can be set to 4 mmol / L.

[0117] S602. When the third predicted blood glucose parameter is within the preset blood glucose range, compare the third predicted blood glucose parameter with the first target blood glucose value. After the comparison, the following two results will occur:

[0118] S603. When the third predicted blood glucose parameter is less than the first target blood glucose value, at this time, according to the difference between the third predicted blood glucose parameter and the first target blood glucose value, control the insulin pump to reduce the basal infusion rate of insulin to the first basal infusion rate. For example, if the current basal infusion rate is 0.5 U / h, it may be reduced to 0.4 U / h or 0.45 U / h after adjustment according to the difference.

[0119] In addition, according to the magnitude of the obtained difference, the reduction amplitude of the basal infusion rate is also different. For example, if the difference is large (e.g., more than 3.3 mmol / L), it can be considered to reduce the basal infusion rate by 20%; if the difference is small (e.g., between 1.7 - 3.3 mmol / L), it can be considered to reduce the basal infusion rate by 10%.

[0120] S604. When the third predicted blood glucose parameter is greater than the first target blood glucose value, according to the difference between the third predicted blood glucose parameter and the first target blood glucose value, control the insulin pump to increase the basal infusion rate of insulin to the second basal infusion rate. For example, if the current basal infusion rate is 0.5 U / h, it may be increased to 0.6 U / h or 0.55 U / h after adjustment according to the difference.

[0121] In addition, according to the magnitude of the obtained difference, the increase amplitude of the basal infusion rate is also different. For example, if the difference is large (e.g., more than 3.3 mmol / L), it can be considered to increase the basal infusion rate by 20%; if the difference is small (e.g., between 1.7 - 3.3 mmol / L), it can be considered to increase the basal infusion rate by 10%.

[0122] Of course, the infusion adjustment method for the insulin pump includes but is not limited to the above several. In this solution, as long as the control of the basal infusion rate of insulin can be achieved according to the obtained difference.

[0123] In steps S603 and S604, the control of the insulin pump to reduce the basal infusion rate of insulin to the first basal infusion rate, and the control of the insulin pump to increase the basal infusion rate of insulin to the second basal infusion rate specifically include the following steps:

[0124] S605. Obtain the total daily dose (TDD) of insulin for the human body, and calculate the total daily basal rate value (TBI) of the human body according to the total daily dose of insulin.

[0125] In this step, the calculation method of the total daily dose (TDD) of insulin for the human body varies according to the specific conditions of the patient (such as whether the patient has received insulin treatment, type of diabetes, body weight, etc.). The following takes the patient who has not received insulin treatment as an example.

[0126] For newly diagnosed diabetes patients, the initial insulin dose can be estimated according to body weight. For example: for a type 2 diabetes patient with a body weight of 70 kg, the initial insulin dose is 70×0.5 = 35 U / day (minimum value) to 70×0.8 = 56 U / day (maximum value).

[0127] After obtaining the total daily dose of insulin, the total daily basal rate value (TBI) allocated is equal to the total daily dose of insulin (TDD) x (40% - 60%). Optionally, the total daily basal rate value (TBI) allocated is equal to the total daily dose of insulin (TDD) x (50%).

[0128] S606. Calculate the average daily basal rate (Bagv) of the human body according to the total daily basal rate value (TBI). Specifically: the average daily basal rate (Bagv) is equal to TBI / 24.

[0129] S607. Calculate the target basal infusion rate of the insulin pump according to the average daily basal rate (Bagv), and the target basal infusion rate is the first basal infusion rate or the second basal infusion rate after reduction or increase. The specific calculation method can be:

[0130] If it is less than the target blood glucose value, it is reduced to the first basal infusion rate (Bcur1), and the first basal infusion rate (Bcur1) = Bagv - linear proportionality coefficient (K) x (first target blood glucose value - third predicted blood glucose parameter).

[0131] If it is greater than the target blood glucose value, it is increased to the second basal infusion rate (Bcur2), and the current basal rate (Bcur2) = Bagv + linear proportionality coefficient (K) x (third predicted blood glucose parameter - first target blood glucose value).

[0132] Among them, the linear proportionality coefficient K needs to be determined according to the specific conditions of the patient (such as whether the patient has received insulin treatment, type of diabetes, body weight, etc.). For example, taking an adult diabetes patient (body weight 70KG) who has not received insulin treatment as an example, the linear proportionality coefficient K can be set to 0.4 - 0.6.

[0133] Through the above steps, the target basal infusion rate of the insulin pump can be calculated and set according to the total daily insulin dose of the patient, so as to achieve more accurate blood glucose control.

[0134] In step S6, according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range, the insulin infusion amount of the insulin pump is controlled, which specifically further includes the following steps:

[0135] S611. When the third predicted blood glucose parameter is outside the preset blood glucose range, compare the third predicted blood glucose parameter with the upper limit value and the lower limit value of the preset blood glucose range. For example, the blood glucose target range for adult diabetic patients may be set to 3.9 - 10.0 mmol / L, then the upper limit value of the preset blood glucose range is 10.0 mmol / L, and the lower limit value is 3.9 mmol / L.

[0136] S612. When the obtained third predicted blood glucose parameter is less than the lower limit value of the preset blood glucose range (such as 3.9 mmol / L), control the insulin pump to reduce the insulin infusion amount to zero, that is, control the insulin pump to stop insulin infusion, so as to avoid the occurrence of hypoglycemia, and ensure the blood glucose safety of the patient through real-time monitoring and dynamic adjustment.

[0137] S613. When the third predicted blood glucose parameter is greater than the upper limit value of the preset blood glucose range, control the insulin pump to infuse a micro-large dose within the fourth preset time. The above steps are aimed at infusing a small amount of insulin in a short time to avoid too high blood glucose. The micro-large dose can be calculated according to the patient's blood glucose level, insulin sensitivity, and the difference between the predicted blood glucose and the upper limit of the target range.

[0138] More specifically, the mode of infusing the micro-large dose may include the square wave large dose mode and the dual wave large dose mode. The square wave large dose mode is to evenly infuse insulin within the preset time; the dual wave large dose mode means that a part of the insulin is immediately infused, and the other part is slowly infused within the preset time.

[0139] Optionally, the fourth preset time can be selected as a time within 1 minute, for example: 10 seconds, 20 seconds, or 30 seconds, etc.

[0140] In addition, during the infusion of the micro-large dose, the change of blood glucose needs to be closely monitored. If the blood glucose drops too fast, the infusion amount should be reduced in time or the infusion should be suspended.

[0141] In the above solution, when it is predicted that the blood glucose level will exceed the target range, infusing a micro-large dose (SMB) can quickly provide the required insulin to quickly reduce the blood glucose level and reduce blood glucose fluctuations. Compared with changing the basal injection rate, the micro-large dose (SMB) can provide the required insulin earlier, so as to reduce the blood glucose faster and effectively prevent postprandial hyperglycemia, etc.

[0142] In step S6, controlling the insulin infusion amount of the insulin pump according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range specifically further includes the following steps:

[0143] S614. When the third predicted blood glucose parameter is less than the lower limit value of the preset blood glucose range, control the insulin pump to issue an alarm prompt. Specifically, the insulin pump can remind the user that the current blood glucose level is lower than the preset lower limit value by means of sound alarms or vibration prompts, etc. Such an alarm can be continuous until the user confirms or the blood glucose returns to normal. If the insulin pump is connected to the controller at this time, the controller will also display an alarm interface to show the prompt of low blood glucose and stop infusion. Through the alarm and prompt, the user can timely discover the hypoglycemia situation and take measures (such as eating sugary foods) to correct the hypoglycemia, which is convenient for the user to quickly understand the situation and take actions.

[0144] Through the above steps, when the third predicted blood glucose parameter is higher than the preset range, the insulin pump can be effectively controlled to timely adjust the bolus dose during meals, so as to better manage the blood glucose level.

[0145] In step S2, calibrating and calculating the second blood glucose parameter with the first blood glucose parameter as the standard value to obtain the calibrated blood glucose parameter specifically includes the following steps:

[0146] S21. Initially collect the second blood glucose parameter and calculate the difference between the initially collected second blood glucose parameter and the first blood glucose parameter.

[0147] S22. According to the above difference, perform offset calibration on the subsequently collected second blood glucose parameters.

[0148] In the above steps, the specific calibration method is:

[0149] Add the above difference to the subsequently collected second blood glucose parameters, so that the second blood glucose parameters are offset-calibrated according to the difference to obtain the calibrated blood glucose parameters. The calibrated blood glucose data can be used for more accurate blood glucose management, helping patients and medical staff make better treatment decisions. During the subsequent continuous monitoring process, repeat the above steps regularly to ensure the accuracy of the blood glucose data.

[0150] By correcting the blood glucose data and using the calibrated blood glucose parameters for subsequent blood glucose monitoring and analysis, the accuracy of blood glucose monitoring can be improved.

[0151] In step S5, obtaining the third predicted blood glucose parameter according to the first predicted blood glucose parameter and the second predicted blood glucose parameter specifically includes the following steps:

[0152] S51. Take the average value of the first predicted blood glucose parameter and the second predicted blood glucose parameter to obtain the third predicted blood glucose parameter.

[0153] Specifically, the third predicted blood glucose parameter obtained in the above steps is the final predicted data, which is confirmed by the following two parts:

[0154] One part predicts the blood glucose value after 20 minutes or other time (i.e., the first predicted blood glucose parameter) based on the trend change of the past blood glucose data of the continuous glucose monitoring system and the blood glucose standard data of the blood glucose meter. The other part estimates how much the blood glucose will decrease after 20 minutes or other time based on the past insulin infusion amount, that is, the remaining insulin amount in the body (the acquisition method can be based on Figure 6 the active insulin curve shown or other methods such as direct detection), and then compares it with the corrected blood glucose value to obtain the predicted blood glucose value after 20 minutes or other time (i.e., the second predicted blood glucose parameter).

[0155] The average value of the two is taken to obtain the finally predicted blood glucose value (i.e., the third predicted blood glucose parameter), and the formula is: Third predicted blood glucose parameter = (First predicted blood glucose parameter + Second predicted blood glucose parameter) / 2.

[0156] Through the above steps, the first predicted blood glucose parameter and the second predicted blood glucose parameter can be combined, and different prediction models (blood glucose parameter trend prediction and human insulin amount prediction) can be comprehensively considered to obtain a more accurate blood glucose prediction value, so as to better guide the adjustment of the insulin infusion amount.

[0157] Preferably, the real-time adjustment method of the insulin infusion amount further includes the following steps:

[0158] S7. Real-time obtain the insulin infusion data of the insulin pump, and control the insulin infusion amount of the insulin pump according to the insulin infusion data and the corrected blood glucose parameter or the third predicted blood glucose parameter.

[0159] Specifically, the insulin infusion data obtained in the above steps includes insulin infusion amount, insulin basal infusion rate, remaining insulin amount, etc. The obtained data is uploaded to the insulin management system or other monitoring systems through the controller 100 or the controller 100, the cloud platform 104 and the computer 99. Doctors or diabetes educators can view the real-time status of each patient through the system. According to these insulin infusion data, it is helpful to adjust the treatment plan in time and improve the accuracy and safety of blood glucose control.

[0160] It is worth mentioning that the operator described in the technical solution of the present invention can be a doctor, a nurse or the patient himself / herself, and the present invention does not make specific limitations.

[0161] The technical means disclosed by the solution of the present invention are not limited to the technical means disclosed in the above embodiments, but also include technical solutions composed of any combination of the above technical features. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present invention.

Claims

1. A real-time adjustment method for insulin infusion volume, characterized in that It includes the following steps: S1. Set a preset blood glucose range and obtain the first blood glucose parameter of the human body at intervals; S2. Continuously obtain the second blood glucose parameter of the human body regularly according to the first preset time, and perform calibration calculation on the second blood glucose parameter with the first blood glucose parameter as the standard value to obtain a corrected blood glucose parameter; S3. Predict the first predicted blood glucose parameter within the subsequent third preset time according to the trend change of the corrected blood glucose parameter within the past second preset time and the currently obtained corrected blood glucose parameter; S4. Obtain the remaining insulin amount of the human body according to the insulin infusion amount within the past second preset time, and predict the second predicted blood glucose parameter within the subsequent third preset time according to the remaining insulin amount and the currently obtained corrected blood glucose parameter; S5. Obtain a third predicted blood glucose parameter according to the first predicted blood glucose parameter and the second predicted blood glucose parameter, and compare the third predicted blood glucose parameter with the preset blood glucose range; S6. Control the insulin infusion amount of the insulin pump according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range; Wherein, the second preset time is greater than the first preset time, and the second preset time is greater than or equal to the third preset time.

2. The real-time adjustment method of insulin infusion amount according to claim 1, characterized in that, The controlling the insulin infusion amount of the insulin pump according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range specifically includes: S601. Set a first target blood glucose value within the preset blood glucose range; S602. When the third predicted blood glucose parameter is within the preset blood glucose range, compare the third predicted blood glucose parameter with the first target blood glucose value; S603. When the third predicted blood glucose parameter is less than the first target blood glucose value, control the insulin pump to reduce the basal infusion rate of insulin to a first basal infusion rate according to the difference between the third predicted blood glucose parameter and the first target blood glucose value; S604. When the third predicted blood glucose parameter is greater than the first target blood glucose value, control the insulin pump to increase the basal infusion rate of insulin to a second basal infusion rate according to the difference between the third predicted blood glucose parameter and the first target blood glucose value.

3. The real-time adjustment method of insulin infusion amount according to claim 2, characterized in that The controlling the insulin pump to reduce the basal infusion rate of insulin to a first basal infusion rate and the controlling the insulin pump to increase the basal infusion rate of insulin to a second basal infusion rate specifically include: S605. Obtain the total daily insulin amount of the human body, and calculate the total daily basal rate numerical amount of the human body according to the total daily insulin amount; S606. Calculate the total daily average basal rate speed of the human body according to the total daily basal rate numerical amount; S607. Calculate the target basal infusion rate of the insulin pump according to the total daily average basal rate speed, and the target basal infusion rate is the first basal infusion rate or the second basal infusion rate.

4. The real-time adjustment method of insulin infusion amount according to claim 2, characterized in that, The controlling the insulin infusion amount of the insulin pump according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range specifically further includes: S611. When the third predicted blood glucose parameter is outside the preset blood glucose range, compare the third predicted blood glucose parameter with the upper limit value and the lower limit value of the preset blood glucose range; S612. When the third predicted blood glucose parameter is less than the lower limit value of the preset blood glucose range, control the insulin pump to reduce the insulin infusion amount to zero; S613. When the third predicted blood glucose parameter is greater than the upper limit value of the preset blood glucose range, control the insulin pump to infuse a micro-large dose within the fourth preset time.

5. The real-time adjustment method of insulin infusion amount according to claim 4, characterized in that, Controlling the insulin infusion amount of the insulin pump according to the comparison result between the third predicted blood glucose parameter and the preset blood glucose range specifically further includes: S614. When the third predicted blood glucose parameter is less than the lower limit value of the preset blood glucose range, control the insulin pump to issue an alarm prompt.

6. The real-time adjustment method of insulin infusion amount according to claim 1, characterized in that Calibrating and calculating the second blood glucose parameter with the first blood glucose parameter as the standard value to obtain a calibrated blood glucose parameter, specifically including: S21. Initially collect the second blood glucose parameter, and calculate the difference between the initially collected second blood glucose parameter and the first blood glucose parameter; S22. According to the difference, perform offset calibration on the subsequently collected second blood glucose parameters.

7. The real-time adjustment method of insulin infusion amount according to claim 1, characterized in that Obtaining the third predicted blood glucose parameter according to the first predicted blood glucose parameter and the second predicted blood glucose parameter, specifically including: S51. Take the average value of the first predicted blood glucose parameter and the second predicted blood glucose parameter to obtain the third predicted blood glucose parameter.

8. The real-time adjustment method of insulin infusion amount according to claim 1, characterized in that It further includes the following steps: S7. Real-time obtain the insulin infusion data of the insulin pump, and control the insulin infusion amount of the insulin pump according to the insulin infusion data and the calibrated blood glucose parameter or the third predicted blood glucose parameter.

9. A closed-loop infusion system, characterized in that, It includes a controller, a blood glucose detection system, an insulin pump, and a continuous glucose monitoring system. The controller is electrically connected to the insulin pump, and the insulin pump is electrically connected to the continuous glucose monitoring system; Wherein, the blood glucose detection system is used to intermittently obtain the first blood glucose parameter of the human body and send the first blood glucose parameter to the controller; The controller is used to send a start instruction to the insulin pump and send the first blood glucose parameter to the insulin pump; The continuous glucose monitoring system is used to real-time obtain the second blood glucose parameter of the human body and send the second blood glucose parameter to the insulin pump; The insulin pump is used to infuse insulin for the human body according to the first blood glucose parameter and the second blood glucose parameter, and send the insulin infusion data to the controller.

10. The closed-loop infusion system according to claim 9, wherein It further includes a computer and a cloud platform. The cloud platform is electrically connected to the computer and the controller respectively; Wherein, the cloud platform is used to send a start instruction to the controller and receive the insulin infusion data of the controller; The computer is used to send a start instruction to the cloud platform and receive the insulin infusion data of the cloud platform.

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