Fully Closed Loop at Home (FCL@Home)

Type 1 Diabetes Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

• NCT number: NCT06041971
• Study type: Interventional
• Source: University of Colorado, Denver
• Contact: Lindsey Towers
• Phone: 303-724-8620
• Email: Lindsey.Towers@cuanschutz.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Completion date: October 31, 2024