CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Fully Closed Loop (FCL) +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04877730
NCT04877730N/ACompleted
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Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation

University of Virginia·interventional·Posted May 7, 2021·Updated May 23, 2024

In Brief

A clinical study evaluating Fully Closed Loop (FCL), Fully Closed Loop with meal anticipation module (FCL+), and 1 other intervention for Type 1 Diabetes. Completed, enrolled 50 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 7, 2021
Enrollment StartMay 21, 2021
Primary CompletionMar 4, 2022
Study CompletionMar 6, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.2 years ago

Interventions

Fully Closed Loop (FCL)device

Closed loop without a meal anticipation module without announced carbohydrate

Fully Closed Loop with meal anticipation module (FCL+)device

Closed loop with a meal anticipation module and without announced carbohydrate

Hybrid Closed Loop (HCL)device

Closed loop without a meal anticipation module with announced carbohydrate