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Completed

NCT Number: NCT04161131

Overcoming Barriers and Obstacles to Adopting Diabetes Devices

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ONBOARD

Behavioral

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)

Primary outcomes

  1. Hemoglobin A1c (HbA1c)

    Time frame: baseline, month 3

    Glycated haemoglobin (HbA1c)

Secondary outcomes

  1. 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)

    The number of participants who withdraw or are lost to followup over the course of the study is used as a measure of attrition

  2. Number of Eligible Individuals Who Agree to Participate in the Study

    Time frame: During screening visit (up to 50 minutes)

    Number of eligible individuals who agree to participate in the study out of all those approached during recruitment

  3. Satisfaction With Intervention Survey

    Time frame: Month 3

    Participant-rated Satisfaction Survey: Individual question scores are presented, each was measured on a Likert scale (0-4), higher scores mean more satisfaction.

  4. 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)

    Baseline and 3-month followup continuous glucose monitor values for percent time spent between 70-180mg/dl

  5. Diabetes Distress Scale for Type 1 Diabetes

    Time frame: baseline, month 3

    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

  6. Glucose Monitoring System Satisfaction Survey (GMSS-T1D)

    Time frame: baseline, month 3

    Scale title "Glucose Monitoring System Satisfaction Survey - Type 1 Diabetes" Min:1 Max:5 Higher mean scores mean worse outcome

  7. 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)

    Baseline and 3-month follow-up percentage of continuous glucose monitoring values using data available from device for use in analyses.

  8. Mean Glucose Level

    Time frame: baseline, month 3

    Mean glucose level from continuous glucose monitoring data at baseline and month 3

  9. Barriers to Diabetes Device Use Survey

    Time frame: baseline, month 3

    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

  10. Diabetes Technology Attitudes Survey

    Time frame: Baseline, Month 3

    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

  11. Fear of Hypoglycemia - Worry Survey

    Time frame: baseline, month 3

    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

  12. Hypoglycemia Confidence Scale

    Time frame: baseline, month 3

    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

  13. Technology Use For Diabetes Problem Solving Scale

    Time frame: baseline, month 3

    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

  14. INSPIRE Survey

    Time frame: baseline, month 3

    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

  15. Frequency of Blood Glucose Monitoring

    Time frame: 3 months

    Frequency will be measured as the number of times a day the participant checks blood glucose level using glucose meter

Sponsors and collaborators

Lead sponsor

Molly Tanenbaum

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: ONBOARD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 13, 2019
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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