Automated Insulin Delivery With Pramlintide for Post-Meal Glucose Control

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Solution Overview

Problem

Conventional automatic drug delivery systems struggle to effectively manage glucose levels during the post-prandial period due to the limited aggressiveness in responding to minor glucose deviations, often requiring user interaction to compensate for meal ingestion, leading to extended periods of hyperglycemia.

Innovation Solution

The integration of Pramlintide with insulin delivery systems, either through separate reservoirs or a co-formulation, allows for a less aggressive insulin delivery algorithm to 'catch up' with meal-induced glucose excursions by delaying gastric emptying, reducing the need for user intervention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a less aggressive insulin delivery algorithm is used, then the system can compensate for meal-induced glucose excursions without requiring user interaction, but the system responds more slowly to glucose deviations

Engineering Contradiction:

Improveuser interaction requirementVSAvoidresponse speed to glucose deviations

Core Design Contradiction:

Ease of operationVSSpeed

Solution Approach 1:

The system performs preliminary action by detecting meal ingestion events and administering Pramlintide before significant glucose excursions occur. This preliminary intervention delays gastric emptying and prevents the need for aggressive insulin responses, allowing the less aggressive algorithm to catch up and compensate effectively without requiring user interaction.

Inventive Principle:

Principle #10Preliminary action

2Object-affected harmful factors

If Pramlintide is administered to delay gastric emptying, then the peak post-prandial hyperglycemia is reduced, but the duration of hyperglycemia is extended

Engineering Contradiction:

Improvepeak hyperglycemiaVSAvoidhyperglycemia duration

Core Design Contradiction:

Object-affected harmful factorsVSDuration of action of stationary object

Solution Approach 1:

The system administers Pramlintide in advance of meal ingestion to delay gastric emptying and reduce peak hyperglycemia. By timing the intervention beforehand, the system manages the glucose excursions more effectively throughout the extended post-prandial period.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system uses continuous glucose monitoring feedback to adjust insulin delivery dynamically. The closed-loop algorithm responds to real-time glucose readings and adjusts insulin administration based on the actual glucose trajectory, compensating for the extended duration of hyperglycemia caused by Pramlintide's gastric emptying delay.

Inventive Principle:

Principle #23Feedback

3Reliability

If the insulin delivery system acts more aggressively against minor glucose deviations, then glucose control is improved, but the risk of hypoglycemia increases

Engineering Contradiction:

Improveglucose controlVSAvoidhypoglycemia risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

Pramlintide acts as an intermediary substance that modulates the relationship between meal ingestion and glucose excursions. By delaying gastric emptying and reducing peak hyperglycemia, it allows the insulin delivery system to use less aggressive algorithms while maintaining effective glucose control and reducing hypoglycemia risk.

Inventive Principle:

Principle #24Intermediary (Mediator)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach enhances glucose control during the post-prandial period by allowing the insulin delivery system to respond more effectively to meal-induced glucose fluctuations without causing extended hyperglycemia, thereby improving user convenience and reducing weight gain.

Implementation Method 1

Pramlintide is an analog to the naturally occurring human hormone Amylin, whose primary effect is reduced gastric emptying, and thus decreased acute impact of long-term insulin needs

Methodology Applied

Scientific EffectGastric emptying delay:

Data Source

PatentUS12551619B2Automated insulin delivery system using pramlintide

Publication Date: 2026.02.17 INSULET CORP

AI summary

Disclosed herein are systems and methods for the delivery of insulin and pramlintide using an automated insulin delivery system. In a first embodiment, a drug delivery system is configured to deliver independent doses of insulin and pramlintide. The system monitors the user's blood glucose level and determines when a meal is been ingested and, in response, delivers the dose of pramlintide which, in turn alters the required delivery of insulin. In the second embodiment, the drug delivery system is configured to deliver a co-formulation of insulin and pramlintide as basal doses. The total amount of pramlintide delivered in a most recent pre-determine period of time, for example, 24 hours, is used to alter the aggressiveness of the algorithm which determines the basal doses of the co-formulation.