Modular blood glucose control systems

Inventors

Rosinko, Michael J. • Patel, Himanshu • DAMIANO, Edward R. • EL-KHATIB, Firas H.

Assignees

Beta Bionics Inc

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Publication Number

US-11594314-B2

Patent

Publication Date

2023-02-28

Expiration Date


Abstract

Blood glucose control systems are disclosed. A blood glucose control system can receive a glucose level signal from a glucose sensor operatively coupled to a subject. The system can decode encoded data of the glucose level signal to obtain the glucose level of the subject and the indication of the glucose trend. The system can automatically calculate the dose control signal using a control algorithm configured to calculate regular correction boluses of glucose control agent in response to at least the glucose level of the subject. The system can select a dose control signal encoding profile from a plurality of dose control signal encoding profiles and, based on the dose control signal encoding profile, encode the dose control signal such that the pump controller can read the dose control signal. The system can transmit an encoded dose control signal to the pump controller.

Core Innovation

The disclosure describes a disposable ambulatory medicament pump, a blood glucose control method, and a glucose level control system that receive a glucose level signal from a glucose sensor. These embodiments generate blood glucose control parameters and produce a dose control signal or dose output for administering blood glucose control therapy, incorporating trends in blood glucose control therapy over a therapy period. The disposable ambulatory medicament pump stores medicament for delivery into a subcutaneous depot.

Each embodiment transmits the blood glucose control parameters to a remote electronic device or system when a specified triggering condition is identified. These triggering conditions include a sensory alarm, a medicament reservoir level below a threshold, a transmission request from the remote device or system, or an indication to replace the pump. The disclosure further describes transferring data, adapting pharmacokinetic parameters, and performing staged software updates with version switching to minimize therapy interruption.

Claims Coverage

The independent claims define three inventive features encompassing a disposable ambulatory medicament pump, a method for administering blood glucose control therapy, and a glucose level control system.

Disposable ambulatory medicament pump

The pump comprises a medicament reservoir, pump controller, data interface, memory, and hardware processor that receives a glucose level signal, generates blood glucose control parameters based on therapy trends and the signal, and generates a dose control signal. When a specified triggering condition is satisfied, the pump transmits the parameters to a remote electronic device.

Method for administering blood glucose control therapy

The method uses a hardware processor to receive a glucose level signal, calculate a dose control signal configured to cause administration of blood glucose control therapy into a subcutaneous depot, and generate blood glucose control parameters based on the therapy and dose control signal. The method transmits the parameters to a remote electronic device when an identified triggering condition is satisfied.

Glucose level control system

The system receives a glucose level signal, generates blood glucose control parameters based on the signal, and generates a medicament dose output based on the signal and parameters. When an identified triggering condition is satisfied, the system transmits the parameters to a remote electronic system.

Together, the independent claims cover pump, method, and system implementations that administer blood glucose control therapy using sensor signals and transmit blood glucose control parameters to a remote electronic device or system when an identified triggering condition is satisfied.

Stated Advantages

Staged software updates and version switching are designed to minimize interruption of therapy.

Documented Applications

Administering blood glucose control therapy to a subject using a disposable ambulatory medicament pump or glucose level control system, including coordinating sensor signals, controllers, and insulin or glucagon delivery into a subcutaneous depot.

Transmitting blood glucose control parameters, therapy data, reports, and alerts from a pump or glucose control system to a remote electronic device, network, or cloud computing system upon satisfaction of an identified triggering condition.

Estimating carbohydrate therapy consumed or avoided and reporting nutrition-related metrics in glucose management.

Generating backup injection or pump therapy protocols from tracked insulin dosing, reporting user modifications to therapy settings, and adapting pharmacokinetic control parameters using glycemic-response data.

Paired ambulatory medicament pumps exchanging therapy data and control parameters after pairing.

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