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

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ClinicalTrials.gov Identifier: NCT04672655
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : August 30, 2023
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Molly Tanenbaum, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: ONBOARD Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
Actual Study Start Date : February 17, 2021
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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. There 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Hemoglobin A1c (HbA1c) over time [ Time Frame: baseline, month 3, month 6, month 12 ]
    Glycemic control


Secondary Outcome Measures :
  1. Time in glucose target range [ Time Frame: baseline, month 3, month 6, month 12 ]
    Percent of glucose readings from CGM system between 70-180 mg/dL per unit of time All time points taken together are needed to evaluate this outcome measure

  2. Percent days wearing CGM [ Time Frame: baseline, month 3, month 6, month 12 ]
    We will use date from CGM to calculated % of days while participating in the study that participants wear the device 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.

    Minimum score=1; Maximum score=6; higher 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.

    Minimum score=1; Maximum score=5; higher scores indicate greater satisfaction (better outcome) All time points taken together are needed to evaluate this outcome measure



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672655


Contacts
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Contact: Molly Tanenbaum, PhD (650) 725-3955 mollyt@stanford.edu
Contact: Lydia Liu, BS (650) 498-7634 onboardstudy@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Molly Tanenbaum, PhD    650-725-3955    mollyt@stanford.edu   
Contact: Lydia Liu    650-498-7634    onboardstudy@stanford.edu   
Sub-Investigator: Korey Hood, PhD         
Sub-Investigator: Marina Basina, MD         
Sponsors and Collaborators
Molly Tanenbaum
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Molly Tanenbaum, PhD Stanford University
More Information
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Responsible Party: Molly Tanenbaum, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04672655    
Other Study ID Numbers: 56922
1K23DK119470-01 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: August 30, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases