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

NCT04877730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-23

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Sue Brown, MD · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2022-03-04
Completion
2022-03-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877730 on ClinicalTrials.gov