Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
- Conditions
- Type 1 Diabetes
- Interventions
- Behavioral: ONBOARD
- Registration Number
- NCT04672655
- Lead Sponsor
- Molly Tanenbaum
- Brief Summary
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.
- Detailed Description
The investigators will enroll 178 adults with T1D between 18-50 years of age. Participants must not have been using CGM regularly for past 6 months. Once consented and enrolled, baseline demographic and psychosocial data will be obtained. Participants will receive 12 weeks of CGM supplies at no cost to them and provided with initial standard CGM introduction and education. Participants will then be randomized to receive ONBOARD or CGM-only. Those randomized to the ONBOARD condition will schedule 4 60-minute sessions with study interventionist (every 2 weeks). Hemoglobin A1c values, CGM usage data, and psychosocial data will be collected at baseline, 3-months (post-intervention), and 6- and 12-months post-baseline.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
- Subject is age 18-50 years at time of enrollment
- Subject must not have been using CGM regularly for past 6 months
- Subject has a clinical diagnosis of type 1 diabetes
- Subject comprehends spoken and written English
- Subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol.
- Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONBOARD Intervention Group ONBOARD 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.
- Primary Outcome Measures
Name Time Method Change in Hemoglobin A1c (HbA1c) over time baseline, month 3, month 6, month 12 Glycemic control
- Secondary Outcome Measures
Name Time Method Percent days wearing CGM baseline, month 3, month 6, month 12 We will use date from CGM to calculated % of days while participating in the study that participants wear the device All time points taken together are needed to evaluate this outcome measure
Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) baseline, month 3, month 6, month 12 The GMSS-T1D is a 15-item self-report scale that assesses attitudes towards one's current glucose monitoring system.
Minimum score=1; Maximum score=5; higher scores indicate greater satisfaction (better outcome) All time points taken together are needed to evaluate this outcome measureChange in Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) baseline, month 3, month 6, month 12 The T1-DDS is a 28-item self-report scale that assesses multiple dimensions of diabetes distress.
Minimum score=1; Maximum score=6; higher scores indicate more distress (worse outcome) All time points taken together are needed to evaluate this outcome measureTime in glucose target range baseline, month 3, month 6, month 12 Percent of glucose readings from CGM system between 70-180 mg/dL per unit of time All time points taken together are needed to evaluate this outcome measure
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States