NCT06041971

Fully Closed Loop At Home (FCL@Home)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-10-20
• Completion: 2025-05-05
• First posted: 2023-09-18
• Last updated: 2024-12-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study