Overcoming Barriers and Obstacles to Adopting Diabetes Devices

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: ONBOARD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ONBOARD Intervention<br>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. | Behavioral: ONBOARD<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) | Glycated haemoglobin (HbA1c) | baseline, month 3 | 

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 | 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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) | 
| Mean Glucose Level | Mean glucose level from continuous glucose monitoring data at baseline and month 3 | baseline, month 3 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |