- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04161131
Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD)
A Pilot of ONBOARD: OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices for Adults With T1D
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is age 18-50 years at time of screening
- Subject is within first year of continuous glucose monitor use OR has not been using CGM regularly in the 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ONBOARD Intervention
ONBOARD consists of four 60-minute sessions over 3 months.
Each session will target a key barrier to CGM use: physical, data, social, and trust.
Sessions will be delivered individually to participants by a doctoral level psychologist with diabetes expertise.
Each session will include relevant first-person digital stories told adults to with T1D, recounting how they managed relevant CGM barriers.
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Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin A1c (HbA1c)
Time Frame: baseline, month 3
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Glycated haemoglobin (HbA1c)
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baseline, month 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study
Time Frame: Duration of study participation (up to three months)
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The number of participants who withdraw or are lost to followup over the course of the study is used as a measure of attrition
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Duration of study participation (up to three months)
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Number of Eligible Individuals Who Agree to Participate in the Study
Time Frame: During screening visit (up to 50 minutes)
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Number of eligible individuals who agree to participate in the study out of all those approached during recruitment
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During screening visit (up to 50 minutes)
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Satisfaction With Intervention Survey
Time Frame: Month 3
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Participant-rated Satisfaction Survey: Individual question scores are presented, each was measured on a Likert scale (0-4), higher scores mean more satisfaction.
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Month 3
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Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL
Time Frame: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
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Baseline and 3-month followup continuous glucose monitor values for percent time spent between 70-180mg/dl
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two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
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Diabetes Distress Scale for Type 1 Diabetes
Time Frame: baseline, month 3
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Unabbreviated Scale Title: Diabetes Distress Scale for Type 1 Diabetes (T1-DDS) is a 28-item self-report scale that highlights seven critical dimensions of distress: powerlessness, management distress, hypoglycemia distress, negative social perceptions, eating distress, physician distress, and friends/family distress. A total score is calculated using the mean of all item scores. Subscale scores are calculated using the means of specific items for each subscale. Min Value: 1 Max Value: 6 Higher scores mean worse outcome/more distress |
baseline, month 3
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Glucose Monitoring System Satisfaction Survey (GMSS-T1D)
Time Frame: baseline, month 3
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Scale title "Glucose Monitoring System Satisfaction Survey - Type 1 Diabetes" Min:1 Max:5 Higher mean scores mean worse outcome
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baseline, month 3
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Percentage of CGM Data Downloaded and Available for Analysis
Time Frame: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
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Baseline and 3-month follow-up percentage of continuous glucose monitoring values using data available from device for use in analyses.
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two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
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Mean Glucose Level
Time Frame: baseline, month 3
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Mean glucose level from continuous glucose monitoring data at baseline and month 3
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baseline, month 3
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Barriers to Diabetes Device Use Survey
Time Frame: baseline, month 3
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Title: Barriers to Diabetes Device Use is a 19-item list of barriers to diabetes device use. Participants can select between 0 and 19 barriers. Examples of barriers are: cost, insurance, lack of family support, lack of support from the diabetes care team, and not liking devices on the body. Min: 0 Max: 19 higher scores mean a worse outcome |
baseline, month 3
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Diabetes Technology Attitudes Survey
Time Frame: Baseline, Month 3
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Title: Diabetes Technology Attitudes Survey, a 6-item survey that asks about general attitudes about the role diabetes technology in one's life and the extent to which someone finds technology helpful for managing diabetes. Min: 1 Max: 5 Mean Score, higher score means better outcome |
Baseline, Month 3
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Fear of Hypoglycemia - Worry Survey
Time Frame: baseline, month 3
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Scale Title: Hypoglycemia Fear Survey II - Worry Subscale is an 18-item subscale that presents a list of concerns people with diabetes sometimes have about low blood sugar. Respondents answer based on their level of worry about each item for the past 6 months. A total score is calculated by summing individual item scores. Min: 0 Max: 4 Higher score indicates worse outcome |
baseline, month 3
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Hypoglycemia Confidence Scale
Time Frame: baseline, month 3
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Title: Hypoglycemia Confidence Scale is a 9-item scale that asks about how confident the respondent is in managing problems with hypoglycemia in a range of situations. A total score is calculated using the mean of all item scores. Min: 1 Max: 4 Higher score means better outcome/more confidence |
baseline, month 3
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Technology Use For Diabetes Problem Solving Scale
Time Frame: baseline, month 3
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Scale: Technology Use For Diabetes Problem Solving Scale is a 9-item scale that asks participants to rate how often they use different types of technology (eg phone, websites, looking at graphs of their glucose data) in managing their diabetes, solving problems and finding answers to questions that arise in managing diabetes. A total score is calculated by summing all items. Min: 0 Max: 5 Higher score means a better outcome |
baseline, month 3
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INSPIRE Survey
Time Frame: baseline, month 3
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Title: INsulin Dosing Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE) is a 31-item survey that assesses perceived benefits and burdens of automated insulin delivery systems. A total score is calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100. Min: 1 Max: 5 High score means more positive outcome |
baseline, month 3
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Frequency of Blood Glucose Monitoring
Time Frame: 3 months
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Frequency will be measured as the number of times a day the participant checks blood glucose level using glucose meter
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3 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Tanenbaum ML, Ngo J, Hanes SJ, Basina M, Buckingham BA, Hessler D, Maahs DM, Mulvaney S, Hood KK. ONBOARD: A Feasibility Study of a Telehealth-Based Continuous Glucose Monitoring Adoption Intervention for Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Dec;23(12):818-827. doi: 10.1089/dia.2021.0198.
- Tanenbaum ML, Messer LH, Wu CA, Basina M, Buckingham BA, Hessler D, Mulvaney SA, Maahs DM, Hood KK. Help when you need it: Perspectives of adults with T1D on the support and training they would have wanted when starting CGM. Diabetes Res Clin Pract. 2021 Oct;180:109048. doi: 10.1016/j.diabres.2021.109048. Epub 2021 Sep 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 47667
- P30DK116074 (U.S. NIH Grant/Contract)
- K23DK119470 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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