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

Recruiting
18 - 50 years of age
Both
Phase N/A

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Overview

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.

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

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.

Study details

Type 1 Diabetes

NCT04672655

Molly Tanenbaum

25 January 2024

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