Overcoming Barriers and Obstacles to Adopting Diabetes Devices

Type 1 Diabetes Clinical Trial

— ONBOARD  

Official title:

A Pilot of ONBOARD: OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices for Adults With T1D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161131
• Other study ID #: 47667
• Secondary ID: K23DK119470P30DK
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: October 22, 2020

Study information

• Verified date: August 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 22, 2020
• Est. primary completion date: October 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Intervention

Behavioral:
• ONBOARD
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)

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Molly Tanenbaum	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c)	Glycated haemoglobin (HbA1c)	baseline, month 3
Secondary	Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study	The number of participants who withdraw or are lost to followup over the course of the study is used as a measure of attrition	Duration of study participation (up to three months)
Secondary	Number of Eligible Individuals Who Agree to Participate in the Study	Number of eligible individuals who agree to participate in the study out of all those approached during recruitment	During screening visit (up to 50 minutes)
Secondary	Satisfaction With Intervention Survey	Participant-rated Satisfaction Survey: Individual question scores are presented, each was measured on a Likert scale (0-4), higher scores mean more satisfaction.	Month 3
Secondary	Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL	Baseline and 3-month followup continuous glucose monitor values for percent time spent between 70-180mg/dl	two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
Secondary	Diabetes Distress Scale for Type 1 Diabetes	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
Secondary	Glucose Monitoring System Satisfaction Survey (GMSS-T1D)	Scale title "Glucose Monitoring System Satisfaction Survey - Type 1 Diabetes" Min:1 Max:5 Higher mean scores mean worse outcome	baseline, month 3
Secondary	Percentage of CGM Data Downloaded and Available for Analysis	Baseline and 3-month follow-up percentage of continuous glucose monitoring values using data available from device for use in analyses.	two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
Secondary	Mean Glucose Level	Mean glucose level from continuous glucose monitoring data at baseline and month 3	baseline, month 3
Secondary	Barriers to Diabetes Device Use Survey	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
Secondary	Diabetes Technology Attitudes Survey	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
Secondary	Fear of Hypoglycemia - Worry Survey	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
Secondary	Hypoglycemia Confidence Scale	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
Secondary	Technology Use For Diabetes Problem Solving Scale	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
Secondary	INSPIRE Survey	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
Secondary	Frequency of Blood Glucose Monitoring	Frequency will be measured as the number of times a day the participant checks blood glucose level using glucose meter	3 months