Fully Closed Loop System for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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).
Who Is on the Research Team?
Gregory P Forlenza, MD
Principal Investigator
University of Colorado Anschutz - Barbara Davis Center
Are You a Good Fit for This Trial?
This trial is for people aged 14-60 with Type 1 Diabetes, using an insulin pump and a Dexcom G6 CGM. They must have been diagnosed at least a year ago, not be pregnant or planning pregnancy, willing to use the study's FCL system and follow the protocol including hotel stays and remote monitoring.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Control Period
Two-week control period gathering data on glycemic control and insulin administration with the participants' usual care therapy
Hotel Session
Participants stay at a local hotel/rental for 5 days and 4 nights for initial testing
Remote Monitored At-Home Use
Participants undergo a 7 day/6-night remote monitored at-home use session
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AIDANET system
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Gregory Forlenza
Lead Sponsor
University of Virginia
Collaborator
University of California, San Francisco
Collaborator