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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 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 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06041971
The ClinicalTrials.gov registry entry for NCT06041971 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (96% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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