Glucose level control system with control parameter modification

Inventors

EL-KHATIB, Firas H. • DAMIANO, Edward R.

Assignees

Beta Bionics Inc

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Publication Number

US-11766518-B2

Patent

Publication Date

2023-09-26

Expiration Date


Abstract

A blood glucose control system is configured to modify therapy provided to a subject. The system can cause first therapy to be delivered by the blood glucose control system to a subject during a first therapy period. The first therapy can be delivered based at least in part on a first value of a control parameter used by a control algorithm to generate a dose control signal. The system can determine a first effect corresponding at least in part to the first therapy and autonomously generate a second value of the control parameter. The system can cause second therapy to be delivered by the blood glucose control system to the subject during a second therapy period, wherein the second therapy is delivered based at least in part on the second value of the control parameter.

Core Innovation

The disclosure describes glucose-control methods and systems that modify a control parameter used by a control algorithm to generate a dose control signal. A first parameter value guides therapy during a first therapy period, and a hardware processor autonomously determines a second value based at least in part on an effect corresponding to the first therapy. The second value then guides therapy during a second period, modifying therapy relative to the first value.

The first parameter value is determined using user interaction, external systems, healthcare-provider prescriptions, subject characteristics, or historical therapy data. Therapy effects are evaluated using glucose trends, stability, glycemic data, hypoglycemia risk, and subject-reported effects. Control parameters include insulin pharmacokinetic parameters such as Tmax or T1/2, with adjustments executed iteratively across therapy periods to alter medicament dosing.

Claims Coverage

The independent claims cover a computer-implemented method and an automated glucose control system, presenting three main inventive features directed to initial parameter selection, effect-based therapy modification, and system architecture.

Selection and delivery based on an initial control parameter value

Claim 1 and claim 24 recite receiving a first value of a control parameter used by a control algorithm to deliver or cause delivery of a first therapy during a first period, wherein the value is received via user interaction, external systems, healthcare-provider prescriptions, or determined from subject characteristics or historical therapy data.

Autonomous effect-based determination and delivery of modified therapy

Claim 1 and claim 24 recite autonomously determining a second value of the control parameter as a function based at least in part on an effect corresponding to the first therapy, and delivering or causing delivery of a second therapy based at least in part on the second value to modify therapy relative to the first value.

Automated glucose control system architecture

Claim 24 recites an automated glucose control system comprising a medicament delivery interface configured to connect to a medicament pump, a memory configured to store computer-executable instructions and therapy data, and a hardware processor configured to execute the instructions to perform the parameter determination and therapy delivery control.

Together, the claims cover adapting a control parameter based on an effect of a first therapy to modify subsequent therapy across a computer-implemented method and an automated system.

Stated Advantages

The disclosure describes personalized glucose control through adaptive modification of control parameters based on the effects of delivered therapy.

Documented Applications

Automated glucose control systems and methods that use glucose-level data to generate dose control signals and modify therapy delivered to a subject, including insulin-related control using parameters such as Tmax or T1/2.

Medicament delivery systems comprising an interface configured to connect to a medicament pump for infusing medicament into a subject, including delivery of insulin and glucagon.

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