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NCT06041971 · ClinicalTrials.gov registry record · NA
Fully Closed Loop At Home (FCL@Home)
A NA study of Type 1 Diabetes, sponsored by University of Colorado, Denver.
- Active
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 3
- Study locations
NCT06041971: Active NA study of Type 1 Diabetes, sponsored by University of Colorado, Denver.
NCT06041971 is a NA study of Type 1 Diabetes that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 36 participants, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06041971, a NA study of Type 1 Diabetes, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 3
- Study locations
Study 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).
Primary Outcome
The primary metric for analysis will be change in mean sensor glucose value between the second week of the control usual-care period and the one-week remote monitored at-home FCL period.
Conditions Studied
Interventions
- DEVICE AIDANET system
Study Locations (3)
California
- University of California San Francisco - San Francisco
Colorado
- Barbara Davis Center - Aurora
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2025-05-05 |
| Phase | NA |
What the registry record for NCT06041971 still lists
NCT06041971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which AIDANET system is the first listed.
NCT06041971 reports a single indexed study location in California, Colorado, Virginia.
Frequently Asked Questions
What is clinical trial NCT06041971 about?
NCT06041971 is a clinical study titled "Fully Closed Loop At Home (FCL@Home)". 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...
What is the current status of trial NCT06041971?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2023-11-01. Estimated completion is 2025-05-05.
What conditions does trial NCT06041971 study?
This clinical trial studies the following conditions: Type 1 Diabetes.
What interventions are being tested in trial NCT06041971?
The interventions under investigation include: AIDANET system (DEVICE).
Who is sponsoring clinical trial NCT06041971?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06041971 being conducted?
This trial has 3 study locations across California, Colorado, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 1 Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06041971's enrollment target sits among peer trials
36 114th of 198 higher than 83 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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