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Completed

NCT Number: NCT04672655

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ONBOARD

Behavioral

Session 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM & social situations; Session 4: Building trust with your CGM

Primary outcomes

  1. Change in Hemoglobin A1c (HbA1c) Over Time

    Time frame: baseline, month 3, month 6, month 12

    Glycated hemoglobin

Secondary outcomes

  1. Change in Time in Glucose Target Range

    Time frame: baseline, month 3, month 6, month 12

    14 days of CGM data were used to calculate the change in the percentage glucose readings from CGM system between 70-180 mg/dL per unit of time at each time point. All time points taken together are needed to evaluate this outcome measure.

  2. Change in Percent CGM Wear Time

    Time frame: baseline, month 3, month 6, month 12

    14 days of CGM data were used to calculate the change in percentage of time wearing CGM at each time point. All time points taken together are needed to evaluate this outcome measure.

  3. Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)

    Time frame: baseline, month 3, month 6, month 12

    The T1-DDS is a 28-item self-report scale that assesses multiple dimensions of diabetes distress. Each item is scored from 1 to 6, then items scores are summed and average to calculate a total score (1 to 6): higher item and total scores indicate more distress (worse outcome). All time points taken together are needed to evaluate this outcome measure

  4. Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)

    Time frame: 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. Overall score range is 1 to 5: higher total scores indicate greater satisfaction (better outcome). All time points taken together are needed to evaluate this outcome measure

Sponsors and collaborators

Lead sponsor

Molly Tanenbaum

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: ONBOARD

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2020
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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