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

NCT04672655 | Completed Results

• 2 other identifiers: 569221K23DK119470-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (HbA1c) Over Time

  Glycated hemoglobin

  baseline, month 3, month 6, month 12

Secondary Outcomes (4)

• Change in Time in Glucose Target Range

  baseline, month 3, month 6, month 12

• Change in Percent CGM Wear Time

  baseline, month 3, month 6, month 12

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

  baseline, month 3, month 6, month 12

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

  baseline, month 3, month 6, month 12

Study Arms (2)

ONBOARD Intervention Group

EXPERIMENTAL

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

CGM Only Group

NO INTERVENTION

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.

Interventions

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

ONBOARD Intervention Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Molly Tanenbaum: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Molly Tanenbaum, PhD
• Organization: Stanford University

mollyt@stanford.edu

(650) 725-3955

Study Officials

• Molly Tanenbaum, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: February 17, 2021
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)