Automated Super Bolus Generation for Insulin Pump Glycemic Control

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Solution Overview

Problem

Current insulin infusion systems face challenges in accurately and efficiently managing glycemic responses to meals, particularly in preventing postprandial glucose spikes and reducing the likelihood of insulin stacking, which can lead to hypoglycemia.

Innovation Solution

The implementation of automated super bolus generation techniques, which involve determining an augmented meal bolus and a subsequent postprandial reduction period for basal dosage deliveries, using a closed-loop control system that adjusts insulin delivery based on real-time glucose monitoring and patient-specific data to regulate glucose levels within a tighter range.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a standard meal bolus is delivered to counteract glucose increase from a meal, then the glucose level is controlled, but postprandial glucose spikes occur and insulin stacking may lead to hypoglycemia

Engineering Contradiction:
Improveglycemic control accuracyVSAvoidpostprandial glucose spikes and hypoglycemia risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The insulin delivery is segmented into two distinct phases: an initial augmented meal bolus followed by a postprandial reduction period where basal dosage is temporarily reduced. This segmentation allows the system to address both the immediate need to counteract glucose spikes and the subsequent risk of hypoglycemia, resolving the contradiction between effective glucose control and prevention of harmful fluctuations.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system performs preliminary action by delivering an augmented meal bolus that exceeds the standard calculation before the postprandial glucose spike occurs. This preliminary augmented delivery, followed by temporary basal reduction, proactively prevents both glucose spikes and subsequent hypoglycemia, improving reliability while eliminating harmful effects.

Inventive Principle:
Principle #10Preliminary action

2Duration of action of stationary object

If basal dosage deliveries are maintained at standard levels after meal bolus, then continuous glucose control is provided, but insulin stacking occurs increasing hypoglycemia risk

Engineering Contradiction:
Improvecontinuous insulin coverageVSAvoidinsulin stacking and hypoglycemia
Core Design Contradiction:
Duration of action of stationary objectVSObject-generated harmful factors

Solution Approach 1:

The system implements periodic action by temporarily suspending or reducing basal dosage deliveries for a defined postprandial reduction period after the augmented meal bolus. This periodic interruption prevents insulin stacking during the period when insulin activity is already elevated from the meal bolus, thereby eliminating hypoglycemia risk while maintaining continuous glucose control through the structured dosing pattern.

Inventive Principle:
Principle #19Periodic action

3Measurement precision

If augmented meal bolus exceeds standard calculation, then postprandial glucose control is improved, but risk of hypoglycemia increases without basal reduction

Engineering Contradiction:
Improveglucose level regulation precisionVSAvoidhypoglycemia prevention
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The system uses feedback by implementing a structured postprandial reduction period based on the known pharmacokinetics of insulin and typical glycemic responses to meals. This feedback mechanism automatically adjusts basal dosage delivery timing and magnitude to complement the augmented meal bolus, ensuring that the enhanced glucose control precision does not lead to hypoglycemia, thereby resolving the contradiction between precision and reliability.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS11839744B2Automated super bolus generation
Publication Date: 2023.12.12 MEDTRONIC MINIMED INC
  • US11839744B2 patent drawing
  • US11839744B2 patent drawing
  • US11839744B2 patent drawing

AI summary

Techniques related to automatically generating a super bolus may include determining an amount of an augmented meal bolus to be delivered to a patient for regulating the patient's glycemic response to a meal. The amount of the augmented meal bolus may exceed a sufficient amount for counteracting a glucose level increase caused by the meal. In some embodiments, the techniques may further include determining a duration of a postprandial reduction period during which basal dosage deliveries to the patient are to be reduced. In some other embodiments, the techniques may further include delivering the augmented meal bolus to the patient prior to determining whether or not to cause reduction of basal dosage deliveries. More specifically, a glucose level of the patient may be obtained after delivery of the augmented meal bolus, and the obtained glucose level may be used to determine whether to reduce basal dosage deliveries.