ONBOARD Program for Type 1 Diabetes (ONBOARD Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByMolly Tanenbaum, PhD

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Molly Tanenbaum

No Placebo Group

Trial Summary

What is the purpose of this trial?This study is a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with T1D the skills to maximize benefit and minimize daily interference from barriers associated with Continuous Glucose Monitoring (CGM) and increase readiness for closed loop.

Eligibility Criteria

The ONBOARD trial is for English-speaking adults aged 18-50 with type 1 diabetes who haven't been using Continuous Glucose Monitoring (CGM) regularly in the past 6 months. It's not suitable for those with medical or neurological disorders that could affect their participation as judged by the study team.

Inclusion Criteria

I am between 18 and 50 years old.

I have been diagnosed with type 1 diabetes.

Participant Groups

ONBOARD is a behavioral intervention designed to help adults with type 1 diabetes overcome barriers to using CGM devices and prepare them for closed loop systems, which automate insulin delivery based on glucose levels.

2Treatment groups

Experimental Treatment

Active Control

Group I: ONBOARD Intervention GroupExperimental Treatment1 Intervention

Those randomized to the ONBOARD group will receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They will also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.

Group II: CGM Only GroupActive Control1 Intervention

Those randomized to the CGM Only group will not receive the ONBOARD intervention during their 12-month participation in the study. There will only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.