NCT04877730

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Fully Closed Loop (FCL)	Closed loop without a meal anticipation module without announced carbohydrate
DEVICE	Fully Closed Loop with meal anticipation module (FCL+)	Closed loop with a meal anticipation module and without announced carbohydrate
DEVICE	Hybrid Closed Loop (HCL)	Closed loop without a meal anticipation module with announced carbohydrate

Timeline

• Start date: 2021-05-21
• Primary completion: 2022-03-04
• Completion: 2022-03-06
• First posted: 2021-05-07
• Last updated: 2024-05-23
• Results posted: 2023-05-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study