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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: ONBOARD

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ONBOARD Intervention Group; 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; Session 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM & social situations; Session 4: Building trust with your CGM
No Intervention: CGM Only Group; Those randomized to the CGM Only group will not receive the ONBOARD intervention during their 12-month participation in the study. They 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?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c (HbA1c) Over Time	Glycated hemoglobin	baseline, month 3, month 6, month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time in Glucose Target Range	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.	baseline, month 3, month 6, month 12
Change in Percent CGM Wear Time	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.	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. 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	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. 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	baseline, month 3, month 6, month 12

Collaborators and Investigators

• Sponsor: Molly Tanenbaum
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Molly Tanenbaum, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Actual): September 16, 2024
• Study Completion (Actual): September 16, 2024

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 56922; 1K23DK119470-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No