Glucose control system with automatic adaptation of glucose target
Inventors
EL-KHATIB, Firas H. • DAMIANO, Edward R. • Russell, Steven J.
Assignees
Boston University • General Hospital Corp
Publication Number
US-12280241-B2
Publication Date
2025-04-22
Expiration Date
2036-08-08
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Abstract
A glucose control system employs adaptation of a glucose target (set-point) control variable in controlling delivery of insulin to a subject to maintain euglycemia. The glucose target adapts based on trends in actual glucose level (e.g., measured blood glucose in the subject), and/or computed doses of a counter-regulatory agent such as glucagon. An adaptation region with upper and lower bounds for the glucose target may be imposed. Generally the disclosed techniques can provide for robust and safe glucose level control. Adaptation may be based on computed doses of a counter-regulatory agent whether or not such agent is actually delivered to the subject, and may be used for example to adjust operation in a bihormonal system during periods in which the counter-regulatory agent is not available for delivery.
Core Innovation
The invention relates to a glucose control system that automatically adapts the glucose target (set-point) used in delivering insulin or insulin analogs to a subject in order to maintain euglycemia. The system determines the glucose target dynamically based on trends in actual measured glucose levels and/or computed doses of a counter-regulatory agent such as glucagon or dextrose. Adaptation of the glucose target may be constrained within upper and lower bounds for safety, and may be implemented whether or not the counter-regulatory agent is available for actual delivery.
The main problem addressed by the invention is the challenge of safely and robustly maintaining blood glucose control in people requiring insulin therapy. In prior systems, fixed glucose targets did not account for longer-term trends such as repeated hypoglycemia events or the potential/actual dosages of counter-regulatory agents, making tight glucose control difficult without risking hypoglycemia or requiring extra user intervention. This invention solves that problem by enabling the glucose target to respond to such trends, allowing automated, real-time adaptation in a variety of system configurations, including both insulin-only and bihormonal (insulin and counter-regulatory agent) systems.
The adaptation may be based on computed counter-regulatory doses even when such agents are not delivered, for instance in insulin-only systems or when the delivery channel is unavailable. Alternatively, the adaptation can use recorded glucose level trends, especially emphasizing low or near-low levels or the subject's mean glucose, or any combination of the above. The system may also allow a user to override the adaptive mode and choose a static glucose target temporarily.
Claims Coverage
There is one independent claim that sets forth several main inventive features.
Automatic adaptation of glucose target in control system
A method of operating a glucose control system that automatically calculates an adapted value of the target glucose level signal by: - Using an electronic processor configured to generate dose control signals in response to the measured glucose level signal and the target glucose level signal. - Calculating corrective doses of at least one glucose control agent (including insulin or insulin analog) based on the target glucose level signal and variations of the glucose level signal over a short correction dose period (seconds to minutes). - Calculating an adapted target glucose level signal based at least on a function of the glucose level signal over a longer period than the correction dose period, where the function is a weighted sum using a scaling factor that varies depending on the respective measured glucose levels. - Generating the dose control signal to cause delivery of corrective doses calculated using the adapted target glucose level signal.
The inventive feature centers on a dynamic and adaptive calculation of the glucose target signal for control of glucose agent dosing, based on longer-term glucose measurements and scaling factors that vary with glucose level values.
Stated Advantages
Provides robust and safe glucose level control by adapting the glucose target based on trends and/or computed counter-regulatory doses.
Reduces total administered insulin while achieving essentially the same glucose control effect over a period compared to use of a constant glucose target.
Limits the frequency, duration, or severity of low or near-low glucose levels to provide safer and more stable glucose control.
Maintains the mean glucose over time within a targeted range to minimize long-term complications of diabetes.
Modulates or limits actual or computed doses of counter-regulatory agents, providing safer and more stable glucose control.
Documented Applications
Automated insulin delivery systems for ambulatory diabetes care.
Glucose control systems in both insulin-only and bihormonal (insulin and counter-regulatory agent) configurations.
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