Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation

Type 1 Diabetes Clinical Trial

Official title: Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation

Status Completed

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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

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