NCT06041971

Fully Closed Loop At Home (FCL@Home)

Active, enrolled NA Last updated 18 December 2024

What this trial tests

NA trial testing AIDANET system in Type 1 Diabetes in 36 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 November 2023

Primary endpoint
20 October 2024

5 May 2025

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	36
Start date	1 November 2023
Primary completion	20 October 2024
Estimated completion	5 May 2025
Sites	3 locations across United States

Drugs / interventions tested

• AIDANET system

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

University of Colorado, Denver

Who can join

Adults 14 to 60, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Performance-Based Adaptation Index for Automated Insulin Delivery Systems.
   Diaz C JL, Colmegna P, Pryor E, Breton MD. · · 2026 · cited 3× · PMID 39910927 · DOI 10.1177/19322968251315499
2. Research Gaps, Challenges, and Opportunities in Automated Insulin Delivery Systems.
   Jacobs PG, Levy CJ, Brown SA, Riddell MC, et al · · 2025 · cited 2× · PMID 40590464 · DOI 10.1177/19322968251338754
3. Miniaturized Neural Networks for Deploying Fully Closed Loop Insulin Delivery Systems: A Pilot Study Featuring Flexible Meal Announcement Options.
   Pryor EC, Moscoso-Vasquez M, Fulkerson D, Holmes V, et al · · 2025 · cited 1× · PMID 40781999 · DOI 10.1177/19322968251364283