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Clinical Trial Summary

The purpose of this study is to test the meal anticipation module on a closed loop algorithm, assessing efficacy and safety.


Clinical Trial Description

This is a pilot study to assess glycemic responses to three different approaches to insulin dosing for carbohydrate ingestion, with different approaches to a closed-loop system in random order; 1. without the meal anticipation module and without carbohydrate announcement (FCL) 2. with the meal anticipation module and without carbohydrate announcement (FCL+) 3. without the meal anticipation module and with carbohydrate announcement (HCL), This study will target completion of up to 36 adults in a randomized cross-over trial, comparing blood glucose time in range 70-180 mg/dL following meals with and without the meal anticipation module in use (FCL+ vs FCL), and comparing to a system with carb announcement instead of a meal anticipation module (HCL). The study will also assess safety when dinner is consumed later than usual and when a lunch is consumed without having been entrained in the meal anticipation module. Each participant will complete each of the 3 modules in random order. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04877730
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase N/A
Start date May 21, 2021
Completion date March 6, 2022

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