Type 1 Diabetes Mellitus Clinical Trial
Official title:
Early Feasibility Study of Adaptive Advisory/Automated (AAA) Control of Type 1 Diabetes
The purpose of this study is to use an Advisory/Automated Adaptive (AAA) Control system for insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood glucose levels. This protocol represents a culmination of prior clinical trials in development of this AAA control system and benefits from the synthesis of those components.
Our overall goal is to evaluate the feasibility of the AAA control system by comparing, in a
randomized cross-over study, the three stages of AAA Control (Advice, Automation, and
Adaptation) to state-of-the art Continuous Glucose Monitor (CGM)-augmented insulin pump
therapy in supervised home-like setting. To achieve this goal, the study will take place in
an outpatient setting.
To test the feasibility of "bedside" closed-loop control we will use an approach comprised
of standard sensor-augmented pump therapy during the day using off-the-shelf devices and
overnight closed-loop control using experimental devices in supervised outpatient setting.
We hypothesize that the AAA control system will prevent nocturnal hypoglycemia and will
increase time within target (80-140 mg/dl) overnight for 5 consecutive nights compared to 5
consecutive nights with CGM-augmented pump alone. Additionally we have an exploratory
hypothesis that overnight control will lead to improved time in target during the day.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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