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ACTIVE NOT RECRUITING
NCT06041971
NA

Fully Closed Loop At Home (FCL@Home)

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

Summary

Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing a session with up to 6 participants with a lower HbA1c (\<8.0%) in one of 3 age categories (26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with a higher HbA1c (8.0-12.0%) with the same age categories (26-60, 18-25, or 14-17 years). The trial will aim to complete a total of 36 participants: 12 total participants within each age category and 18 participants within each HbA1c category; 12 participants at each site. The study may enroll up to 70 participants to account for dropouts across the study. The study will be performed for 5 days and 4 nights at a local hotel/rental. Following the hotel session, participants will undergo a 7 day/6-night remote monitored at-home use session. The study will also conduct a two-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy. Participants will be randomized 1:1, stratified by age cohort, to either group A (control period prior to AIDANET use) or group B (control period after AIDANET use).

Official title: Safety and Feasibility Testing of a Fully Closed Loop System in Adolescents and Adults with Higher Baseline HbA1c Values

Key Details

Gender

All

Age Range

14 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-11-01

Completion Date

2025-05-05

Last Updated

2024-12-18

Healthy Volunteers

No

Conditions

Interventions

DEVICE

AIDANET system

The study will involve testing a new AID system designed to enable full closed loop control and consisting of the following elements: the diabetes assistant (DiAs) prototyping platform (MAF 2019), connected to a Tandem t:AP research insulin pump and a Dexcom G6 CGM, and implementing the University of Virginia (UVA) AIDANET algorithm.

Locations (3)

University of California San Francisco

San Francisco, California, United States

Barbara Davis Center

Aurora, Colorado, United States

University of Virginia

Charlottesville, Virginia, United States