Clinical trial NCT04161131: Overcoming Barriers and Obstacles to Adopting Diabetes Devices
Official title: A Pilot of ONBOARD: OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices for Adults With T1D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-11-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will create a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with type 1 diabetes (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 proposed research will create and refine the ONBOARD intervention for CGM use. Participants will be tracked using metrics of A1c, time in glucose target range, number of days using CGM, blood glucose (BG) downloads, diabetes problem solving, diabetes distress, and technology attitudes. The investigators will examine whether ONBOARD leads to improved diabetes and psychosocial outcomes and sustained CGM use. At the end of this study, the investigators will have created and refined a comprehensive, multicomponent intervention package to promote increased and sustained uptake of CGM and increase readiness for closed loop adoption.

Eligibility criteria: Inclusion Criteria:

1. Subject is age 18-50 years at time of screening
2. Subject is within first year of continuous glucose monitor use OR has not been using CGM regularly in the 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.

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: baseline, month 3
Secondary outcomes:
measure: Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study
timeFrame: Duration of study participation (up to three months)
measure: Number of Eligible Individuals Who Agree to Participate in the Study
timeFrame: During screening visit (up to 50 minutes)
measure: Satisfaction With Intervention Survey
timeFrame: Month 3
measure: Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL
timeFrame: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
measure: Diabetes Distress Scale for Type 1 Diabetes
timeFrame: baseline, month 3
measure: Glucose Monitoring System Satisfaction Survey (GMSS-T1D)
timeFrame: baseline, month 3
measure: Percentage of CGM Data Downloaded and Available for Analysis
timeFrame: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
measure: Mean Glucose Level
timeFrame: baseline, month 3
measure: Barriers to Diabetes Device Use Survey
timeFrame: baseline, month 3
measure: Diabetes Technology Attitudes Survey
timeFrame: Baseline, Month 3
measure: Fear of Hypoglycemia - Worry Survey
timeFrame: baseline, month 3
measure: Hypoglycemia Confidence Scale
timeFrame: baseline, month 3
measure: Technology Use For Diabetes Problem Solving Scale
timeFrame: baseline, month 3
measure: INSPIRE Survey
timeFrame: baseline, month 3
measure: Frequency of Blood Glucose Monitoring
timeFrame: 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Molly Tanenbaum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.