Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
Part of paid clinical trials in Stanford, California.
- Sponsor
- Molly Tanenbaum
- Study ID
- NCT04672655
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- ONBOARD — BEHAVIORALSession 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM \& social situations; Session 4: Building trust with your CGM
Study Details
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.
Key Dates
- Start date
- Feb 17, 2021
- Status verified
- Aug 2025
- Primary completion
- Sep 16, 2024
- Completion
- Sep 16, 2024
Study Design
- Enrollment
- 150 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ONBOARD Intervention GroupThose 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.
- No Intervention: CGM Only GroupThose randomized to the CGM Only group will not receive the ONBOARD intervention during their 12-month participation in the study. They 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.
Primary Outcome Measure
Change in Hemoglobin A1c (HbA1c) Over Time [ Time Frame: baseline, month 3, month 6, month 12 ]
Locations (1)
| Facility | City | State | ZIP |
|---|---|---|---|
| Stanford University | Stanford | California | 94305 |
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