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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

Tracking Information
First Submitted Date  ICMJE December 11, 2020
First Posted Date  ICMJE December 17, 2020
Last Update Posted Date August 30, 2023
Actual Study Start Date  ICMJE February 17, 2021
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2020)		 Change in Hemoglobin A1c (HbA1c) over time [ Time Frame: baseline, month 3, month 6, month 12 ]
Glycemic control
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2020)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2020)
  • Time in glucose target range [ Time Frame: post interventions (3-months) and 6 and 12 months post-baseline ]
    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
  • Percent Days wearing CGM [ Time Frame: post interventions (3-months) and 6 and 12 months post-baseline ]
    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
  • Change in Diabetes Distress Scale-T1D [ Time Frame: baseline, 3, 6, and 12 months post-baseline ]
    Diabetes Distress Scales-T1D is a 28-item survey validated for use in T1D adults. The survey contains 7 subscales: Powerlessness, Management Distress, Hypoglycemia Distress, Negative Social Perceptions, Eating Distress, Physician Distress, and Friend/Family Distress All time points taken together are needed to evaluate this outcome measure
  • Change in Perceived Benefit of CGM [ Time Frame: baseline, 3, 6, and 12 months post-baseline ]
    Glucose Monitoring System Satisfaction Survey (GMSS-T1D) is a 15-item validated survey to assess attitudes towards CGM All time points taken together are needed to evaluate this outcome measure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
Official Title  ICMJE Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: ONBOARD
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2020)		 178
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2024
Estimated Primary Completion Date July 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Molly Tanenbaum, PhD (650) 725-3955 mollyt@stanford.edu
Contact: Lydia Liu, BS (650) 498-7634 onboardstudy@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04672655
Other Study ID Numbers  ICMJE 56922
1K23DK119470-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Molly Tanenbaum, Stanford University
Original Responsible Party Molly Tanenbaum, Stanford University, Instructor
Current Study Sponsor  ICMJE Molly Tanenbaum
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Molly Tanenbaum, PhD Stanford University
PRS Account Stanford University
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP