Clinical trial NCT04672655: Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
Official title: Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-12-17
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 3 weeks).
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subject is age 18-50 years at time of enrollment
2. Subject must not have been using CGM regularly for past 6 months
3. Subject has a clinical diagnosis of type 1 diabetes
4. Subject comprehends spoken and written English

Exclusion Criteria:

1. Subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol.
2. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.

Primary outcomes:
measure: Change in Hemoglobin A1c (HbA1c) over time
timeFrame: baseline, month 3, month 6, month 12
Secondary outcomes:
measure: Time in glucose target range
timeFrame: baseline, month 3, month 6, month 12
measure: Percent days wearing CGM
timeFrame: baseline, month 3, month 6, month 12
measure: Change in Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS)
timeFrame: baseline, month 3, month 6, month 12
measure: Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)
timeFrame: baseline, month 3, month 6, month 12
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Molly Tanenbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References: