METHOD AND SYSTEM FOR MANAGEMENT OF DIABETES WITH A GLUCOSE MONITOR AND INFUSION PUMP TO PROVIDE FEEDBACK ON BOLUS DOSING

• US 20150157792A1
• Filed: 12/05/2013
• Published: 06/11/2015
• Est. Priority Date: 12/05/2013
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: CHOVANDA, Sweta, MORALES, Carlos Omar
• Granted Patent: US 9,861,747 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Described and illustrated is a system for management of diabetes that includes an infusion pump, glucose sensor and controller with a method programmed into the controller. The infusion pump is configured to deliver insulin to a subject. The system provides the user with the ability to understand the effects of bolus insulin dosing upon their glucose levels. Specifically, the system provides a message that must include: (a) the trend of the user'"'"'s glucose; (b) the recommended bolus; and (c) the actual bolus.

Claims

1. A method for operating a diabetes management system having an infusion pump, at least one glucose monitor and a microcontroller, the method comprising the following steps performed with the microcontroller:

determining a glucose measurement in which a fluid sample with glucose is transformed into enzymatic byproducts by application of electrical signals to the sample;

calculating a bolus recommendation based on the glucose measurement made by the determining step;

evaluating whether the bolus recommendation was followed by a user of the system;

in the event the bolus recommendation was not followed by the user then;

storing the actual bolus delivered by the infusion pump;

measuring the glucose value in subsequent fluid samples and if the glucose values over time is greater than a predetermined high trend threshold then annunciating a high glucose trend, along with the recommended bolus and the actual bolus delivered by the pump otherwise if the glucose values over time is less than a predetermined low trend threshold then annunciating a low glucose trend along with both the recommended bolus and the actual bolus delivered by the pump.

2. The method of claim 1, further comprising the step of storing the glucose measurement made by the measuring step in the controller.

3. The method of claim 1, further comprising the step of ascertaining a need for another bolus recommendation due to an input to the controller.

4. The method of claim 1, in which the ascertaining comprises a declining rate of change in the glucose measurements of fluid samples of the user.

5. The method of claim 1, in which the glucose monitor comprises a continuous glucose monitor and the microcontroller comprises a closed-loop controller.

6. The method of claim 5, in which the annunciating of the high glucose trend comprises displaying a message that a trend of glucose measurements is increasing after a bolus delivery along with both the recommended bolus and the actual bolus delivered.

7. The method of claim 5, in which the annunciating of the low glucose trend comprises displaying a textual message that a trend of glucose measurements is decreasing after a bolus delivery along with both the recommended bolus and the actual bolus delivered.

8. The method of claim 1, in which the low trend threshold comprises a decreasing rate of glucose concentration about 20 mg/dL every thirty minutes and the high trend threshold comprises an increasing rate of change of glucose concentration of about 20 mg/dL every thirty minutes.

10. The system of claim 8, in which the low trend threshold comprises a decreasing rate of glucose concentration about 20 mg/dL every thirty minutes and the high trend threshold comprises an increasing rate of change of glucose concentration of about 20 mg/dL every thirty minutes.

9. A system for management of diabetes, the system comprising:

an episodic glucose meter to measure glucose level in a fluid sample of a subject at discrete non-uniform time intervals and provide such episodic glucose level as input data for bolus calculation;

a continuous glucose monitor to continuously measure glucose level of the subject at discrete generally uniform time intervals and provide the glucose level at each interval in the form of glucose measurement data that can be used for bolus calculation;

an insulin infusion pump to deliver insulin to the subject;

a microcontroller in communication with the pump, glucose meter and the glucose monitor in which the microcontroller is configured to provide a bolus recommendation to the subject, evaluate whether an actual bolus delivered by the pump is other than the bolus recommendation;

in the event the actual bolus delivered is other than the bolus recommendation, determine a trend of glucose values over a period of time and annunciate one of a low trend or high trend to the user along with actual bolus delivered and bolus recommendation.