Insulin delivery management in closed-loop systems

Abstract

A control device (30) for managing insulin delivery in a closed-loop system. The control device (30) includes a calculation module (32). The calculation module (32) is configured to receive a target basal rate indicating a target insulin delivery rate from an insulin pump (20) and to calculate an additional basal rate if the target basal rate exceeds a flow threshold. The additional basal rate is substantially equal to the difference between the target basal rate and the flow threshold. The control device (30) also includes an insulin management module (34). The insulin management module is configured to determine a recommendation value for a control parameter of the insulin pump (20). The recommendation value is based on the additional basal rate multiplied by a period of time. The control device (30) includes a communication module (36).The communication module (36) is configured to send the recommendation value to the insulin pump. Figure to be published with the abbreviation: [Fig. 1].

Description

Title of the invention: Insulin delivery management in closed-loop systems. FIELD OF THE INVENTION

[0001] The present invention relates to the management of insulin delivery in closed-loop systems, and more particularly to a device and a method for adjusting insulin delivery according to a target basal rate, a flow threshold and a defined period of time.

[0002] BACKGROUND OF THE INVENTION

[0003] Closed-loop insulin delivery systems have revolutionized diabetes management by automating insulin delivery in response to real-time glucose monitoring. These systems aim to maintain blood glucose levels within a target range by adjusting insulin delivery based on continuous feedback from glucose sensors. Despite advances in these systems, optimizing insulin delivery to account for the dynamic and individual nature of glucose metabolism in diabetic patients remains challenging.

[0004] One of the main challenges of closed-loop insulin delivery is accurately predicting and managing insulin requirements over time. Current systems do not always account for the variability in insulin absorption and action, which can lead to over- or under-administration of insulin. Furthermore, the insulin delivery rate by the pump is often capped at a maximum threshold to prevent hypoglycemia, which can limit the system's ability to respond to sudden increases in insulin demand.

[0005] Furthermore, integrating various components into closed-loop systems, such as sensors, pumps, and control algorithms, presents challenges in ensuring reliable communication and coordinated action. Any disruption to this integration can compromise the system's ability to maintain glucose levels within the desired range, which poses risks to patient health.

[0006] There is therefore a constant demand for improvements in closed-loop insulin delivery systems that allow for more precise and adaptive management of insulin delivery, taking into account the fluctuating and personalized insulin needs of patients, while ensuring the safety and effectiveness of the system.

[0007] The invention thus aims to address at least partially the technical problems presented above.

[0008] BRIEF SUMMARY OF THE INVENTION

[0009] A control device for managing insulin administration in a closed-loop system, the control device comprising:

[0010] - a calculation module, the calculation module being configured to:

[0011] o receive a target basal rate indicating a target insulin delivery rate of an insulin pump;

[0012] o calculate an additional base flow rate if the target base flow rate is greater than a flow rate threshold, the additional base flow rate being substantially equal to the difference between the target base flow rate and the flow rate threshold;

[0013] - an insulin management module; the insulin management module is configured to determine a recommended value for an insulin pump control parameter, the recommended value being based on the additional basal rate multiplied by a period of time; and

[0014] - a communication module, the communication module being configured for send the recommended value to the insulin pump.

[0015] According to one embodiment, the control device is integrated into an insulin pump.

[0016] The ability of the calculation module to receive a target basal rate indicating a target insulin delivery rate from an insulin pump allows the control device to dynamically adapt to the user's insulin requirements as determined by the closed-loop system as this target basal rate is determined by the closed-loop system. Insulin delivery is thus adapted to the patient's current physiological state, which can improve blood glucose control.

[0017] The ability of the calculation module to calculate an additional basal rate if the target basal rate exceeds a flow threshold solves the problem of insulin pumps having a maximum basal rate limit. By calculating the additional basal rate, the control device can manage insulin delivery even when the user's insulin requirements exceed the pump's programmed flow threshold, thus improving the safety and efficiency of insulin delivery.

[0018] The insulin management module's function of determining a recommended value for an insulin pump control parameter, based on the additional basal rate multiplied by a period of time, enables precise control of insulin delivery. This helps mitigate the risks associated with over- or under-administration of insulin, which are common problems in diabetes management.

[0019] In the context of the invention, the term "indicator" refers to a value or signal that serves as an instruction or guideline for the operation of the pump to insulin. It represents a target or predicted amount of insulin to be administered, as opposed to the amount actually administered, which can vary due to potential inaccuracies or variations in insulin pump performance. The target value is used by the control device to make decisions and manage the insulin delivery process, but it does not necessarily guarantee the precise amount of insulin that will be administered to the patient.

[0020] In the context of this disclosure, the term “substantially equal” is used to describe a value that is approximately equal to another value, with a tolerance of plus or minus 5%. This term acknowledges minor variations that may occur in practice, such as those due to measurement inaccuracies, system tolerances, or other factors that could result in a slight deviation from exact numerical equivalence. Thus, when a value is described as being substantially equal to another, it is understood that the value may be 5% higher or lower than the value to which it is compared, while still achieving the intended purpose or function of the control device.

[0021] In the context of this disclosure, the term “flow threshold” refers to the maximum basal rate that can be set on an insulin pump due to software limitations inherent in pump programming. This maximum basal rate acts as a ceiling on the insulin delivery rate, beyond which the pump software does not allow the basal rate to be increased. The flow threshold is a predetermined value set in the pump software to prevent excessive insulin delivery, which could pose a risk to the patient. It is a safety feature designed to ensure that insulin delivery remains within safe operating parameters, as defined by the pump's capabilities and regulatory requirements.However, in the context of a closed-loop system, this flow rate threshold, which is a safety measure in other settings, can be seen as a limitation to optimizing insulin delivery. This is because it prevents the control device from closely adapting to fluctuations in the user's insulin requirements throughout the day. The closed-loop system aims to dynamically adjust insulin delivery to the user's current physiological state, but the flow rate threshold could limit the system's ability to deliver insulin doses that more accurately match the user's immediate insulin needs. Consequently, the rate threshold may prevent the closed-loop system from achieving strict glycemic control, which is essential for diabetes management.

[0022] In the context of this disclosure, the term "period of time" refers to a period of time. The period of time may be a predetermined period of time, that is, a fixed period of time established in advance, based on from a schedule, a standard protocol, or a specific time sequence. The time period can also be a variable period, which can change or adjust in response to various factors, such as physiological signals, environmental conditions, or system feedback. This variability allows the time period to be dynamically adapted to the requirements or current states of the system or process to which it is associated.

[0023] In the context of this document, the term "recommendation value of an insulin pump control parameter" refers to an insulin bolus, which is a dose of insulin delivered by the pump in response to the control device's recommendation. The recommendation value is calculated to be reasonably equal to the supplemental basal rate multiplied by a period of time, effectively translating the supplemental basal rate into a discrete insulin bolus to be administered at specific intervals. This bolus is intended to compensate for any difference between the target basal rate and the flow threshold, ensuring that the patient receives the appropriate amount of insulin, as determined by the closed-loop system's algorithm. The control device's communication module is responsible for sending this bolus recommendation to the insulin pump, which then delivers the insulin accordingly.

[0024] According to one embodiment, the communication module is configured to send the recommendation value to the insulin pump only if no recommendation value has been sent during the previous time period.

[0025] In the context of this document, the expression "previous time period" refers to the interval immediately preceding the present moment and extending backward during the time period of a defined "time period." For example, if the specified period is ten minutes, the previous time period will correspond to the last ten minutes preceding the current time. This concept is particularly relevant when determining the timing of actions or events, such as sending recommendation values ​​to an insulin pump, where it is imperative to ensure that these actions are not repeated more frequently than the defined time period.

[0026] This feature allows the control device to prevent excessive insulin delivery by ensuring that recommendation values ​​are not sent to the insulin pump more frequently than the defined time period. This is particularly useful when the insulin pump is programmed to deliver boluses at regular intervals, as it reduces the risk of dose stacking, which could lead to hypoglycemia. By incorporating a control mechanism that prevents the communication module from sending recommendation values ​​during the preceding time period, the device The control system ensures that insulin delivery is correctly timed according to the patient's physiological needs and the technical capabilities of the insulin pump. This feature is particularly advantageous in closed-loop systems where insulin requirements change dynamically and the system frequently calculates new recommended values. The control device thus improves the safety and efficiency of insulin delivery, providing a more reliable and patient-centered diabetes management solution.

[0027] According to one embodiment, the time period is at least five minutes and at most thirty minutes.

[0028] The technical effects of a time period of at least five minutes and at most thirty minutes are numerous. First, this range allows the control device to make sufficiently frequent adjustments to insulin delivery to respond to rapid changes in the patient's physiological state, such as fluctuations in blood glucose levels. A minimum of five minutes allows the system to react relatively quickly to these changes, which is particularly useful immediately after meals or during exercise, when blood glucose levels can vary more rapidly.

[0029] In a closed-loop system, insulin delivery recommendations are often based on readings from a continuous glucose monitor (CGM), a device that measures glucose levels in the interstitial fluid at regular intervals to provide a continuous assessment of the body's glucose concentration. To conserve energy and reduce the frequency of data transmissions, which can be energy-intensive, the CGM typically sends its readings to the control device every five minutes. This allows the closed-loop system to make informed decisions about insulin delivery while maintaining efficient energy use.

[0030] On the other hand, the maximum limit of thirty minutes helps to avoid excessively delayed responses to changes in blood glucose levels, which could compromise blood glucose control. By limiting the time period to thirty minutes, the control device ensures that adjustments to insulin delivery are made at sufficiently frequent intervals to maintain strict glycemic control without causing significant fluctuations in glucose levels.

[0031] Furthermore, this range of time periods allows for some flexibility in programming the control device to take into account the capabilities of different insulin pumps and various patient-specific factors, such as insulin sensitivity and absorption rates. This flexibility is particularly advantageous in a closed-loop system where personalized diabetes management is a priority.

[0032] In summary, the technical effects include the ability to adjust insulin delivery in a timely and responsive manner, the prevention of insulin administration delays, and the flexibility to adapt the operation of the control device to individual patient needs and the technical specifications of different insulin pumps. These effects collectively contribute to the objective of achieving and maintaining strict glycemic control in a safe and patient-appropriate manner.

[0033] According to one embodiment, the time period is substantially equal to ten minutes.

[0034] A reasonably long period of time of ten minutes allows the control device to establish a consistent and manageable interval for insulin delivery adjustments in the closed-loop system. This ten-minute interval corresponds to the frequency at which the closed-loop system algorithm typically issues recommendations, thus ensuring that the actions of the control device are synchronized with the system's calculation cycle.

[0035] By setting the time period to a reasonable ten-minute interval, the control device can effectively mitigate the risks of over- or under-administration of insulin by providing a regular and predictable schedule for insulin delivery. This interval also helps to balance the delivery of reactive insulin with the prevention of dose stacking, which could otherwise lead to hypoglycemia if boluses were administered too frequently. The ten-minute time period thus contributes to the overall goal of strict blood glucose control by allowing the control device to adapt insulin delivery to the user's changing physiological needs in a timely and safe manner.

[0036] Since the CGM transmits data every five minutes, a ten-minute time period is a sensible choice, as this period not only aligns with the CGM's data delivery cycle but also provides a sufficiently narrow window to allow for timely adjustments to insulin delivery, thus facilitating a rapid response to changes in glucose levels. At the same time, it is wide enough to avoid the risk of dose stacking, which is a concern when insulin doses are infused too close together. Therefore, a ten-minute time period represents a good compromise between the desire to quickly adjust the patient's insulin requirements and mitigating the risks associated with dose stacking. This balance is crucial to ensuring the effectiveness and safety of the closed-loop system's insulin delivery regimen.

[0037] Another technical effect of the time period being reasonably equal to ten minutes is to ensure that the calculation of the resulting bolus is greater than the minimum bolus that the pump is capable of delivering. When the calculation is performed over a five-minute period, there is a higher risk of encountering situations where the calculated bolus cannot be sent to the pump, potentially resulting in insulin under-delivery. By using a ten-minute period, the control device increases the likelihood that the calculated bolus will exceed the pump's minimum delivery threshold, thus ensuring more consistent and accurate insulin delivery. This approach helps maintain the intended insulin delivery profile and promotes more precise glycemic control in the closed-loop system.

[0038] According to one embodiment, the flow threshold is determined on the basis of the maximum basic flow rate that can be set on the insulin pump.

[0039] Such a feature allows the control device to fully utilize the potential of the insulin pump's capabilities. By aligning the flow threshold with the pump's maximum basal rate, the control device can ensure that insulin delivery is optimized according to the pump's technical constraints, thus avoiding the unnecessary use of a recommended value when it is not justified. This approach enables precise management of insulin delivery, ensuring that the patient receives the appropriate amount of insulin determined by the closed-loop system's algorithm, without exceeding the safety limits designed for the pump.Therefore, this feature of the control device improves the safety and efficiency of insulin delivery, as it prevents the risk of hypoglycemia that could result from over-administration, while ensuring that the patient's insulin needs are met even when they reach the upper limit of the pump's delivery capacity.

[0040] In one embodiment, the flow rate threshold is equal to the maximum basal rate that can be set on the insulin pump. This flow rate threshold is a specific value that the insulin pump software recognizes as the upper limit for basal insulin delivery. This is, for example, a safety measure intended to prevent the pump from delivering an excessive amount of insulin, which could lead to hypoglycemia or other adverse effects. The flow rate threshold is determined by the technical specifications and safety protocols programmed into the insulin pump, and it represents the maximum rate at which the pump can deliver basal insulin over a given period of time. However, this upper limit can be a limitation in a closed-loop context where the objective is to continuously and dynamically adjust insulin delivery to the patient's real-time physiological conditions.In cases where the patient's insulin requirements exceed the flow threshold, the closed-loop system may be used. unable to deliver the precise amount of insulin calculated as ideal based on the patient's current glucose levels and other physiological parameters. This limitation can hinder the system's ability to maintain strict glycemic control, which is particularly detrimental to patients with fluctuating insulin sensitivity or who experience rapid changes in their glucose levels. Therefore, while the flow threshold serves as a safeguard against excessive insulin delivery, it also presents a challenge for the closed-loop system, which must operate at its full potential to personalize diabetes management.

[0041] According to one embodiment, the recommended value of an insulin pump control parameter is substantially equal to the additional basal rate multiplied by the time period.

[0042] This feature of the control device ensures that the insulin pump delivers a calculated dose of insulin that closely matches the supplemental basal rate over the defined time period. By multiplying the supplemental basal rate by the time period, the control device translates the continuous flow into a discrete bolus quantity that can be administered by the insulin pump at appropriate intervals. This method of calculating the recommended value allows for precise insulin delivery, tailored to the patient's needs as determined by the closed-loop system, while respecting the technical limitations of the insulin pump. The term "substantially equal" acknowledges minor variations that may occur in practice, such as those due to measurement inaccuracies or system tolerances, thus providing a degree of flexibility in the operation of the control device.This calculated approach to insulin delivery improves the system's ability to maintain strict glycemic control and reduces the risk of hypoglycemia associated with excessive insulin administration.

[0043] In this case, to ensure that the target basal rate is achieved, the insulin pump's basal insulin rate is set to the flow threshold. This setting serves as the basal insulin delivery rate, which, combined with the recommendation value, ensures that the overall insulin delivery meets the target basal rate. The control device thus orchestrates insulin delivery using the basal rate set at the flow threshold and supplementing it with the calculated recommendation value, which is based on the additional basal rate multiplied by the time period. This strategy allows the control device to bypass the limitations imposed by the flow threshold, thereby enabling the delivery of insulin doses that correspond to the patient's dynamic insulin requirements, as determined by the closed-loop system.

[0044] According to one embodiment, the recommended value of an insulin pump control parameter is substantially equal to the sum of the additional basal flow rate multiplied by the time period and the flow rate threshold multiplied by the time period.

[0045] This aspect of the control device ensures that the insulin pump delivers a calculated dose of insulin that is the sum of two components: the supplemental basal rate and the flow threshold, each multiplied by the same time period. This calculation reflects the target basal rate. By combining these two rates over the defined time period, the control device can provide a comprehensive insulin delivery strategy that aligns with the patient's insulin requirements as determined by the closed-loop system, while respecting the maximum basal rate limit of the pump. This approach enables precise and safe insulin delivery, ensuring that the patient's glycemic control is maintained within the desired range.

[0046] In cases where the control device determines that the target basal rate must be achieved entirely by the recommended value, the insulin pump's basal insulin rate is set to zero. This ensures that insulin is delivered solely via the recommended value, without the pump delivering any additional basal insulin. By setting the basal rate to zero in such scenarios, the control device prevents the delivery of basal insulin and thus relies on the accuracy of the recommended value to achieve the desired target basal rate. This approach simplifies the insulin delivery process and can be advantageous in situations where the additional basal rate is high enough to meet the patient's insulin requirements without the pump's basal rate.

[0047] This approach offers a significant technical advantage by overcoming the limitations related to the accuracy of basal rate delivery in some insulin pumps. By relying solely on the recommended value, which is delivered as a bolus, the control device can achieve a higher level of accuracy in insulin delivery. Insulin pumps generally have different levels of accuracy for basal rate delivery compared to bolus delivery. Basal rates are often delivered as small, frequent pulses, which can be subject to limitations and mechanical variations. In contrast, bolus delivery is generally more accurate because it involves a single, larger dose of insulin.By setting the pump's basal insulin rate to zero and administering the full insulin requirement via the recommended value (as a bolus), the control device takes advantage of the highest administration accuracy. by bolus. This method allows for more precise dosing, particularly when small adjustments to insulin delivery are needed to maintain strict glycemic control. This strategy improves the overall accuracy of insulin delivery in the closed-loop system, which can lead to better glycemic control and a reduced risk of hyper- and hypoglycemic events. It demonstrates how the control device can adapt to and overcome hardware limitations, ultimately providing a more refined and personalized approach to insulin therapy.

[0048] The invention also relates to a method of sending a recommendation value for a control parameter of an insulin pump in a closed-loop system, the method being implemented by the control device, as described above and comprising:

[0049] - a step consisting of receiving a target base flow rate indicating a flow rate target insulin delivery of an insulin pump;

[0050] - a step consisting of receiving an additional base flow rate, if the flow rate of is higher than a flow threshold, the additional base flow being substantially equal to the difference between the target base flow and the flow threshold;

[0051] - a step consisting of determining a recommendation value for a parameter insulin pump control, the recommendation value being based on the additional basal rate multiplied by a period of time; and

[0052] - a step consisting of sending the recommendation value to the insulin pump.

[0053] The embodiments, technical effects and definitions disclosed herein by The provisions relating to the control device are also applicable to the method described herein. The method encompasses steps that fully utilize the functionalities and characteristics of the control device described herein. Consequently, all embodiments, technical effects, and definitions relating to the device also apply to the method. This ensures a complete and unified understanding of both the aspects of the invention relating to the control device and the method, thereby facilitating the implementation and use of the disclosed technology across a wide range of applications.

[0054] According to one embodiment, the recommendation value is sent to the insulin pump if no recommendation value has been sent during the previous time period.

[0055] According to one embodiment, the time period is at least five minutes and at most thirty minutes.

[0056] According to one embodiment, the time period is substantially equal to ten minutes.

[0057] According to one embodiment, the flow threshold is determined on the basis of a maximum basic flow rate that can be set on the insulin pump.

[0058] According to one embodiment, the method further comprises receiving a glucose level signal from a continuous glucose sensor, and the recommendation value is determined on the basis of the glucose level signal.

[0059] The inclusion of a glucose level signal from a continuous glucose monitor (CGM) offers a substantial technical advantage by enabling real-time adjustments to insulin delivery based on the data. This feature allows the control device to react dynamically to the patient's immediate glycemic status, which is particularly useful for managing the rapid fluctuations in blood glucose that can occur throughout the day. Using the glucose level signals, the control device can calculate the recommended value with a high degree of accuracy, ensuring that insulin delivery is closely aligned with the patient's current physiological needs. This real-time adjustment capability enhances the safety and effectiveness of the closed-loop system, reducing the risk of hyperglycemia and hypoglycemia, and contributes to improved overall blood glucose control.The continuous feedback provided by the glucose level signal allows the control device to make informed decisions, leading to a more personalized and adaptive approach to diabetes management.

[0060] According to one embodiment, the method further consists of adjusting the value of the recommendation on the basis of an on-board insulin level (OBI).

[0061] Adjusting the recommendation value based on the level of onboard insulin (OBI) provides an additional technical advantage by improving the accuracy of insulin dosing. This adjustment takes into account the residual insulin activity from previous doses, which is a dynamic and patient-specific parameter. By considering the OBI, the control device can prevent insulin stacking, i.e., the accumulation of insulin activity that can lead to hypoglycemia if not properly managed. These adjustments contribute to a more nuanced and individualized insulin delivery strategy, which is essential for achieving the goal of personalized diabetes management and improved patient outcomes.

[0062] In the context of this document, the term "onboard insulin" (OBI) refers to the amount of insulin that has been previously administered and is still active in the body, affecting the patient's blood glucose levels. OBI takes into account the fact that insulin, once administered, continues to lower blood glucose for some time afterward. This period can vary depending on the type of insulin used, the individual's metabolism, and other factors. Physiological. The IOB is a dynamic parameter that decreases as active insulin is metabolized and its hypoglycemic effect diminishes. Accurate consideration of the IOB is imperative in a closed-loop system to avoid excessive insulin administration, which could lead to hypoglycemia if the cumulative effect of active insulin exceeds the patient's current insulin requirements. The control device can adjust the recommended insulin delivery value based on the IOB to ensure the patient receives a safe and effective insulin dose that corresponds to their real-time physiological state.

[0063] The invention also relates to software comprising instructions to cause the control device described above to execute the steps of the process described above.

[0064] The different incompatible aspects defined above can be combined. Brief description of the drawings

[0065] Embodiments of the invention will be described below with reference to the drawings, briefly described below:

[0066] Figure 1 illustrates a control device according to one embodiment of the invention; and

[0067] [Fig.2] illustrates a method of sending a recommendation value according to an embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION

[0068] As shown in [Fig. 1], the invention relates to a control device 30 for managing insulin delivery in a closed-loop system. The control device 30 includes a calculation module 32. The calculation module 32 is configured to receive a target basal rate indicating a target insulin delivery rate from an insulin pump 20 and to calculate an additional basal rate if the target basal rate is greater than a flow threshold, the additional basal rate being substantially equal to the difference between the target basal rate and the flow threshold.The ability of the calculation module to receive a target basal rate indicating a target insulin delivery rate for an insulin pump 20 allows the control device 30 to dynamically adapt to the user's insulin requirements as determined by the closed-loop system as this target basal rate is determined by the closed-loop system. Insulin delivery is thus tailored to the patient's current physiological state, which can improve blood glucose control. The ability of the calculation module to calculate an additional basal rate if the target basal rate exceeds a flow threshold addresses the issue of insulin pumps 20 having a maximum basal rate limit. By calculating the additional basal rate, the device... The 30-command system can manage insulin delivery even when the user's insulin requirements exceed the pump's programmed flow threshold, thus improving the safety and efficiency of insulin delivery.

[0069] The flow rate threshold is determined based on the maximum basal rate that can be set on the insulin pump 20. This feature allows the control device 30 to fully utilize the insulin pump's capabilities. By aligning the flow rate threshold with the pump's maximum basal rate, the control device 30 can ensure that insulin delivery is optimized within the pump's technical constraints, thus avoiding the unnecessary use of a recommended value when it is not justified. This approach enables precise management of insulin delivery, ensuring that the patient receives the appropriate amount of insulin determined by the closed-loop system's algorithm, without exceeding the safety limits designed for the pump.Therefore, this feature of the control device 30 improves the safety and efficiency of insulin delivery, as it prevents the risk of hypoglycemia that could result from overdose, while ensuring that the patient's insulin needs are met even when they reach the upper limit of the pump's delivery capacity. Furthermore, the flow threshold is equal to the maximum basal rate that can be set on the insulin pump 20. This flow threshold is a specific value that the insulin pump software recognizes as the upper limit for basal insulin delivery. This is a safety measure designed to prevent the pump from delivering an excessive amount of insulin, which could lead to hypoglycemia or other adverse effects.The flow rate threshold is determined by the technical specifications and safety protocols programmed into the insulin pump 20, and it represents the maximum flow rate at which the pump can deliver basal insulin over a given period. However, this upper limit can be a limitation in a closed-loop system where the goal is to continuously and dynamically adjust insulin delivery to the patient's real-time physiological conditions. In cases where the patient's insulin requirements exceed the flow rate threshold, the closed-loop system may be unable to deliver the precise amount of insulin calculated as ideal based on the patient's current glucose levels and other physiological parameters.This limitation can impair the system's ability to maintain strict glycemic control, which is particularly detrimental to patients with fluctuating insulin sensitivity or who experience rapid changes in their glucose levels. Therefore, while the flow rate threshold serves as a protective measure against excessive insulin administration, it also represents a [limitation / disadvantage]. challenge for the closed-loop system which must operate at its full potential to personalize diabetes management.

[0070] The control device 30 also includes an insulin management module 34. The insulin management module 34 is configured to determine a recommendation value for a control parameter of the insulin pump 20. The recommendation value is based on the supplemental basal rate multiplied by a time period, the time period being not less than five minutes, not more than thirty minutes, and preferably approximately ten minutes. The function of the insulin management module to determine a recommendation value for a control parameter of the insulin pump 20, based on the supplemental basal rate multiplied by a time period, enables precise control of insulin delivery. This helps mitigate the risks associated with over- or under-administration of insulin, which are common problems in diabetes management.The technical benefits of a time period of at least five minutes and at most thirty minutes are numerous. First, this range ensures that the insulin delivery system can make sufficiently frequent adjustments to respond to rapid changes in the patient's physiological state, such as fluctuations in blood glucose levels. A minimum of five minutes allows the system to react relatively quickly to these changes, which is particularly useful immediately after meals or during exercise, when blood glucose levels can vary more rapidly.In a closed-loop system, insulin delivery recommendations are often based on readings from a continuous glucose monitor (CGM), a device that measures glucose levels in interstitial fluid at regular intervals to provide a continuous assessment of glucose concentration in the body. To conserve energy and reduce the frequency of data transmissions, which can be energy-intensive, the CGM typically sends its readings to the control device every five minutes. This allows the closed-loop system to make informed decisions about insulin delivery while maintaining efficient energy use. Furthermore, the maximum interval of thirty minutes helps prevent delayed responses to changes in blood glucose levels, which could compromise blood glucose control.By limiting the time period to thirty minutes, the 30-minute control device ensures that insulin delivery adjustments are made at sufficiently frequent intervals to maintain strict glycemic control without causing significant fluctuations in glucose levels. Furthermore, this time period range allows for some flexibility in programming the control device to accommodate the varying capabilities of insulin pumps. insulin and various patient-specific factors, such as insulin sensitivity and absorption rates, are taken into account. This flexibility is particularly advantageous in a closed-loop system where personalized diabetes management is a priority. In summary, the technical effects include the ability to adjust insulin delivery in a timely and responsive manner, the prevention of insulin delivery delays, and the flexibility to adapt the operation of the control device to individual patient needs and the technical specifications of different insulin pumps.20 These effects collectively contribute to the goal of achieving and maintaining strict glycemic control in a safe and patient-appropriate manner.

[0071] A reasonably equal time period of ten minutes allows the control device 30 to establish a consistent and manageable interval for insulin delivery adjustments in the closed-loop system. This ten-minute interval corresponds to the frequency at which the closed-loop system's algorithm typically issues recommendations, ensuring that the actions of the control device are synchronized with the system's calculation cycle. By setting the interval to a reasonably equal time period of ten minutes, the control device 30 can effectively mitigate the risks of over- or under-administration of insulin by providing a regular and predictable schedule for insulin delivery.This interval also allows for a balance between reactive insulin delivery and preventing dose stacking, which could otherwise lead to hypoglycemia if boluses were administered too frequently. The ten-minute time period thus contributes to the overall goal of strict glycemic control by allowing the control device 30 to adapt insulin delivery to the user's changing physiological needs in a timely and safe manner. Since the CGM transmits data every five minutes, a ten-minute time period is a sensible choice because it not only aligns with the CGM's data delivery cycle but also provides a sufficiently narrow window to allow for timely adjustments to insulin delivery, thus facilitating a rapid response to changes in glucose levels.At the same time, it is sufficiently long to avoid the risk of dose stacking, which is a concern when insulin doses are infused too close together. Thus, a ten-minute interval represents a good compromise between the desire to quickly adjust the patient's insulin requirements and mitigating the risks associated with dose stacking. This balance is crucial to ensuring the effectiveness and safety of the closed-loop system's insulin delivery regimen. Another technical benefit of a reasonably long ten-minute interval is to ensure that the calculated resulting bolus is greater than the minimum bolus required by the pump. is capable of delivering insulin. When the calculation is performed over a five-minute period, there is a higher risk of encountering situations where the calculated bolus cannot be sent to the pump, potentially resulting in insulin under-delivery. By using a ten-minute period, the control device increases the likelihood that the calculated bolus will exceed the pump's minimum delivery threshold, thus ensuring more consistent and accurate insulin delivery. This approach helps maintain the intended insulin delivery profile and promotes more precise glycemic control within the closed-loop system.

[0072] The control device 30 also includes a recommendation unit 36. The communication module 36 is configured to send the recommendation value to the insulin pump 20. The communication module 36 is configured to send the recommendation value to the insulin pump 20 only if no recommendation value has been sent during the previous time period. This feature allows the control device 30 to prevent excessive insulin delivery by ensuring that recommendation values ​​are not sent to the insulin pump 20 more frequently than the defined time period. This is particularly advantageous in cases where the insulin pump 20 is programmed to deliver boluses at regular intervals, as it reduces the risk of dose stacking, which could lead to hypoglycemia.By incorporating a control mechanism that prevents the communication module 36 from sending recommendation values ​​during the previous time period, the control device 30 ensures that insulin delivery is correctly timed according to the patient's physiological needs and the technical capabilities of the insulin pump 20. This feature is particularly advantageous in closed-loop systems where insulin requirements change dynamically and the system frequently calculates new recommendation values. The control device 30 thus improves the safety and efficiency of insulin delivery, providing a more reliable and patient-centered diabetes management solution.

[0073] According to a first embodiment, the recommended value of a control parameter of the insulin pump 20 is substantially equal to the supplemental basal rate multiplied by the time period. This feature of the control device 30 ensures that the insulin pump 20 delivers a calculated insulin dose that closely corresponds to the supplemental basal rate over the defined time period. By multiplying the supplemental basal rate by the time period, the control device 30 translates the continuous flow into a discrete bolus quantity that can be administered by the insulin pump 20 at appropriate intervals. This method of calculating the recommended value allows for administration Precise insulin delivery, tailored to the patient's needs as determined by the closed-loop system, while respecting the technical limitations of the insulin pump. The term "substantially equal" acknowledges minor variations that may occur in practice, such as those due to measurement inaccuracies or system tolerances, thus providing a degree of flexibility in the operation of the control device. This calculated approach to insulin delivery improves the system's ability to maintain strict glycemic control and reduces the risk of hypoglycemia associated with excessive insulin delivery. In this case, to ensure the target basal rate is achieved, the insulin pump's basal rate is set to the flow threshold.This setting serves as the basal insulin delivery rate which, combined with the recommendation value, ensures that the overall insulin delivery meets the target basal rate. The control device 30 thus orchestrates insulin delivery using the basal rate set at the flow threshold and supplementing it with the calculated recommendation value, which is based on the additional basal rate multiplied by the time period. This strategy allows the control device 30 to bypass the limitations imposed by the flow threshold, enabling the delivery of insulin doses that correspond to the patient's dynamic insulin requirements, as determined by the closed-loop system.

[0074] According to a second embodiment, the recommended value of a control parameter of the insulin pump 20 is substantially equal to the sum of the supplemental basal rate multiplied by the time period and the flow threshold multiplied by the time period. This aspect of the control device 30 ensures that the insulin pump 20 delivers a calculated insulin dose that is the sum of two components: the supplemental basal rate and the flow threshold, each multiplied by the same time period. This calculation reflects the target basal rate. By combining these two rates over the defined time period, the control device 30 can provide a comprehensive insulin delivery strategy that aligns with the patient's insulin requirements as determined by the closed-loop system, while respecting the maximum basal rate limit of the pump.This approach allows for precise and safe insulin delivery, ensuring that the patient's glycemic control is maintained within the desired range. In cases where the control device 30 determines that the target basal rate must be fully achieved by the recommended value, the basal insulin rate of the insulin pump 20 is set to zero. This ensures that insulin is delivered solely via the recommended value, without the pump delivering any additional basal insulin. By setting the basal rate to zero in such scenarios, the control device 30 prevents the delivery of basal insulin, relying on... This approach focuses on the accuracy of the recommendation value for achieving the desired target basal rate. It simplifies the insulin delivery process and can be advantageous in situations where the supplemental basal rate is high enough to meet the patient's insulin needs without relying on the pump's basal rate. This approach offers a significant technical advantage by overcoming the limitations associated with basal rate delivery accuracy in some insulin pumps. By relying solely on the recommendation value, which is delivered as a bolus, the control device can achieve a higher level of accuracy in insulin delivery. Insulin pumps typically have different levels of accuracy for basal rate delivery compared to bolus delivery.Basal rates are often delivered as small, frequent pulses, which can be subject to limitations and mechanical variations. In contrast, bolus delivery is generally more precise because it involves a single, larger dose of insulin. By setting the pump's basal insulin rate to zero and delivering all the required insulin via the recommended value (as a bolus), the 30-unit control device takes advantage of the greater accuracy of bolus delivery. This allows for more precise dosing, especially when small adjustments to insulin delivery are needed to maintain strict glycemic control. This strategy improves the overall accuracy of insulin delivery in the closed-loop system, which can lead to better glycemic control and a reduced risk of hyper- and hypoglycemic events.It demonstrates how the control device 30 can adapt to and overcome hardware limitations, ultimately providing a more refined and personalized approach to insulin therapy.

[0075] The invention also relates to a method of sending a recommendation value for a control parameter of an insulin pump 20 in a closed-loop system; the method is implemented by a control device 30 as described above and comprises:

[0076] - a receiving step 50 of a target base flow rate indicating a flow rate target insulin delivery of an insulin pump 20;

[0077] - a step consisting of calculating 52 an additional base flow rate if the flow rate of target base is greater than a flow threshold determined on the basis of a maximum basal flow that can be set on the insulin pump 20, the additional basal flow being substantially equal to the difference between the target basal flow and the flow threshold;

[0078] - a step consisting of determining 54 a recommendation value for a parameter insulin pump control 20, the recommendation value being based on the additional basal rate multiplied by a period of time of at least five minutes, at most thirty minutes and preferably approximately ten minutes; and

[0079] - a step 56 of sending the recommendation value to the insulin pump 20, in which the recommendation value is sent to the insulin pump 20 if no recommendation value has been sent during the previous time period.

[0080] The embodiments, technical effects, and definitions disclosed herein with respect to the control device 30 are also applicable to the method described herein. The method encompasses steps that fully utilize the functionalities and features of the control device 30 described herein. Therefore, all embodiments, technical effects, and definitions relating to the device also apply to the method. This ensures a complete and unified understanding of both the aspects of the invention relating to the control device 30 and the method, thereby facilitating the implementation and use of the disclosed technology across a wide range of applications.

[0081] The method also includes receiving a glucose level signal from a continuous glucose sensor 12, wherein the recommended value is determined based on the glucose level signal. The inclusion of a glucose level signal from a continuous glucose sensor or CGM offers a substantial technical advantage by enabling real-time adjustments to insulin delivery based on the data. This function allows the control device 30 to react dynamically to the patient's immediate glycemic status, which is particularly useful for managing the rapid fluctuations in blood glucose that can occur throughout the day. Using the glucose level signals, the control device 30 can calculate the recommended value with a high degree of accuracy, ensuring that insulin delivery is closely aligned with the patient's current physiological needs.This real-time adjustment capability enhances the safety and efficiency of the closed-loop system, reducing the risk of hyperglycemia and hypoglycemia, and contributes to improved overall blood glucose control. The continuous feedback provided by the glucose level signal allows the control device to make informed decisions, leading to a more personalized and adaptive approach to diabetes management.

[0082] The method further consists of adjusting the recommendation value according to the on-board insulin level (OBI). Adjusting the recommendation value according to the on-board insulin level (OBI) provides an additional technical advantage by improving the accuracy of insulin dosing. This adjustment takes into account the residual insulin activity from previous doses, which is a dynamic and patient-specific parameter. By taking the OBI into account, the device Ordering 30 can prevent insulin stacking, which is the accumulation of insulin activity that could lead to hypoglycemia if not properly managed. These adjustments contribute to a more nuanced and individualized insulin delivery strategy, which is essential for achieving the goal of personalized diabetes management and improved patient outcomes.

[0083] The invention also relates to software comprising instructions to cause the control device 30 described above to execute the steps of the process described above.

[0084] The invention also relates to a system 10 comprising a CGM 12, an insulin pump 20 and a control device 30.

[0085] This disclosure relates to a control device 30 and a method for managing insulin delivery in closed-loop systems. The disclosed technology is particularly applicable in the field of diabetes management, where it can be used to optimize insulin delivery in response to real-time glucose monitoring. The control device 30 and the method described herein are designed to adapt the insulin quantities recommended by an algorithm to the technical specifications of insulin pumps 20, thereby resolving problems of insulin over- and under-delivery, as well as the limitations imposed by the maximum basal rate that can be set on an insulin pump 20.

[0086] The disclosed technology can be applied in the medical industry, particularly in the development and operation of insulin pumps and closed-loop systems for diabetes management. It can be used by manufacturers of insulin pumps and other medical devices, healthcare providers, and researchers in the field of diabetes management. The technology can also be integrated into existing closed-loop systems to improve their performance and safety.

[0087] Although exemplary embodiments of the invention have been described, it will be understood by those skilled in the art that various changes, omissions, and / or additions may be made, and that equivalents may be substituted for elements thereof without departing from the spirit of the scope of the invention. Furthermore, numerous modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. Therefore, it is intended that the invention is not limited to the particular embodiments disclosed for the implementation of this invention, but that the invention includes all embodiments falling within the scope of the supplementary claims. Moreover, Unless specifically stated, any use of the terms first, second, etc. does not denote any order or importance, but instead the terms first, second, etc. are used to distinguish one element from another.

Claims

Demands

1. A control device (30) for managing insulin delivery in a closed-loop system, the control device (30) comprising: - a calculation module (32), the calculation module (32) being configured to: • receive a target basal rate indicating a target insulin delivery rate from an insulin pump (20); • calculate an additional basal rate, if the target basal rate is greater than a flow threshold, the additional basal rate being substantially equal to the difference between the target basal rate and the flow threshold; - an insulin management module (34); the insulin management module (34) being configured to determine a recommendation value for a control parameter of the insulin pump (20), the recommendation value being based on the additional basal rate multiplied by a period of time;and - a communication module (36), the communication module (36) being configured to send the recommendation value to the insulin pump (20).;

2. Control device (30) according to claim 1, wherein the communication module (36) is configured to send the recommendation value to the insulin pump (20) only if no recommendation value has been sent during the previous time period.

3. Control device (30) according to any one of claims 1 or 2, wherein the time period is at least five minutes and at most thirty minutes.

4. Control device (30) according to claim 3, wherein the time period is substantially equal to ten minutes.

5. Control device (30) according to any one of claims 1 to 4, wherein the flow threshold is determined on the basis of the maximum basic flow rate that can be set on the insulin pump (20).

6. Control device (30) according to any one of claims 1 to 5, wherein the recommendation value of a control parameter of the insulin pump (20) is substantially equal to the additional basal rate multiplied by the time period.

7. Control device (30) according to any one of claims 1 to 5, wherein the recommendation value of a control parameter of the insulin pump (20) is substantially equal to the sum of the additional basal flow rate multiplied by the time period and the flow rate threshold multiplied by the time period.

8. A method for sending a recommendation value of a control parameter of an insulin pump (20) in a closed-loop system, the method being implemented by a control device (30) according to claim 1 and comprising: - a step of receiving (50) a target basal rate indicating a target insulin delivery rate from an insulin pump (20); - a step of calculating (52) an additional basal rate, if the target basal rate is greater than a flow threshold, the additional basal rate being substantially equal to the difference between the target basal rate and the flow threshold; - a step of determining (54) a recommendation value of a control parameter of the insulin pump (20), the recommendation value being based on the additional basal rate multiplied by a period of time; and - a step of sending (56) the recommendation value to the insulin pump (20).

9. A method according to claim 8, wherein the recommendation value is sent to the insulin pump (20), if no recommendation value has been sent during the previous time period.

10. A method according to claim 8 or 9, wherein the time period is at least five minutes and at most thirty minutes.

11. A method according to claim 10, wherein the time period is substantially equal to ten minutes.

12. A method according to any one of claims 8 to 11, wherein the flow threshold is determined on the basis of a maximum basic flow rate that can be set on the insulin pump (20).

13. A method according to any one of claims 8 to 12, further comprising receiving a glucose level signal from a continuous glucose sensor (12), and wherein the recommendation value is determined on the basis of the glucose level signal.

14. A method according to any one of claims 8 to 13, further comprising adjusting the value of the recommendation based on an on-board insulin level (OBI).

15. Computer program comprising instructions to cause the control device (30) according to claim 1 to perform the steps of the process according to claim 8.

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