Automated Insulin Delivery Sleep Mode Transition
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Solution Overview
Problem
Ambulatory insulin pumps face challenges in safely and quickly transitioning to a lower glucose target range during sleep mode to prevent hypoglycemia, as existing systems risk too rapid a switch due to recent bolus delivery and insulin activity.
Innovation Solution
The system determines the transition speed to sleep mode based on the time since the last bolus delivery, estimated insulin on board, and patient-specific glucose data, allowing for immediate or gradual transition to the lower target range to ensure safety and reduce the risk of hypoglycemia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If the system transitions quickly to the lower glucose target range during sleep mode, then time in range is improved and effectiveness is enhanced, but the risk of hypoglycemia increases due to recent bolus delivery and insulin activity
Solution Approach 1:
The system dynamically adjusts the transition speed to sleep mode target range based on real-time conditions. Instead of using a fixed transition rate, the system varies the transition speed according to the time since last bolus, current glucose levels, and insulin activity, allowing faster transitions when safe and slower transitions when risk of hypoglycemia is present
Solution Approach 2:
The system continuously monitors glucose levels, bolus timing, and insulin activity to provide feedback that controls the transition process. This feedback mechanism allows the system to adjust the transition rate to the sleep mode target range in real-time, preventing hypoglycemia while still achieving the desired time in range improvements
2Reliability
If the system uses a gradual transition to the sleep mode target range, then the risk of hypoglycemia is reduced, but the time to achieve the lower target range increases
Solution Approach 1:
The transition rate is made dynamic rather than static. The system adjusts the speed of transition based on multiple factors including time since last bolus, current glucose levels, and predicted insulin activity. This allows the system to transition quickly when conditions permit and slow down when safety concerns arise, optimizing both time efficiency and safety
3Productivity
If the system immediately transitions to the lower glucose target range, then time in range is maximized, but hypoglycemia risk increases due to recent bolus effects
Solution Approach 1:
The system performs preliminary assessment of safety conditions before initiating or accelerating the transition to the sleep mode target range. By evaluating the time since last bolus, current insulin activity, and glucose levels in advance, the system determines whether an immediate or aggressive transition is safe, or if a more gradual approach is required
Solution Approach 2:
Continuous monitoring of glucose levels and bolus timing provides feedback that prevents immediate transition when hypoglycemia risk is present. The system uses this feedback to modulate the transition speed, ensuring that aggressive transitions only occur when safety conditions are met
Data Source
AI summary
Apparatuses and methods for transitioning to sleep mode or otherwise modified glucose target range in automated insulin delivery systems. For example, sleep mode can include a lower glucose target and/or lower and narrower glucose target range because of fewer variables that affect glucose values during sleep such as eating and exercise. Due to increased stability provided by the sleep mode target range, it is desirable to transition to the sleep mode target range as quickly as possible, while ensuring the transition is done safely and does not risk low glucose or hypoglycemia by too quickly switching to the lower and narrower target range. Systems and methods disclosed herein therefore provide various approaches for safely and quickly transitioning to sleep mode or other modified target ranges in order to improve time in range by being more aggressive to get to the lower sleep mode or other target faster without risking hypoglycemia.