Fully Closed Loop System for Type 1 Diabetes

Recruiting at 2 trial locations

Overseen By Lindsey Towers

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Insulin

Must not be taking: SGLT-2 inhibitors

Disqualifiers: Seizure disorder, Heart condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

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

Living with one or more parent/guardian or supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff

Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial

Willingness to participate in all study procedures including the house/hotel session, exercise challenges (e.g., one hour per day during hotel), and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session

Exclusion Criteria

Participant does not have a direct supervisor involved in the conduct of the trial

I am currently taking medication for diabetes that could increase my risk of a specific type of ketoacidosis.

I have a bleeding disorder such as hemophilia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Two-week control period gathering data on glycemic control and insulin administration with the participants' usual care therapy

2 weeks

Hotel Session

Participants stay at a local hotel/rental for 5 days and 4 nights for initial testing

5 days

Remote Monitored At-Home Use

Participants undergo a 7 day/6-night remote monitored at-home use session

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AIDANET system

Trial Overview The AIDANET system is being tested in this trial. Participants will either start with their usual care before switching to AIDANET or vice versa. The study includes a stay at a facility followed by home monitoring to compare glycemic control between usual care and the new system.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 1 Intervention

Two-week control period after the use of the AIDANET system.

Group II: Group A Experimental Treatment 1 Intervention

Two-week control period before the use of the AIDANET system.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Gregory Forlenza

Lead Sponsor

Trials

1

Recruited

40+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+