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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    178
  • sponsor
    Molly Tanenbaum
Updated on 7 October 2022
diabetes
continuous glucose monitoring

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.

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.

Details
Condition Type 1 Diabetes
Treatment ONBOARD
Clinical Study IdentifierNCT04672655
SponsorMolly Tanenbaum
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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