Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: ONBOARD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONBOARD Intervention Group<br>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. | Behavioral: ONBOARD<br>* Session 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM & social situations; Session 4: Building trust with your CGM<br>|
| No Intervention: CGM Only Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c (HbA1c) over time | Glycemic control | baseline, month 3, month 6, month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in glucose target range | 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 | baseline, month 3, month 6, month 12 | 
| Percent days wearing CGM | 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 | baseline, month 3, month 6, month 12 | 
| Change in Diabetes Distress Scale for Adults with Type 1 Diabetes (T1-DDS) | 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 measure | baseline, month 3, month 6, month 12 | 
| Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) | 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 measure | baseline, month 3, month 6, month 12 |