Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD)
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| ClinicalTrials.gov Identifier: NCT04161131 |
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Recruitment Status :
Completed
First Posted : November 13, 2019
Results First Posted : June 8, 2021
Last Update Posted : September 13, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 1 Diabetes | Behavioral: ONBOARD | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 28 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot of ONBOARD: OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices for Adults With T1D |
| Actual Study Start Date : | December 9, 2019 |
| Actual Primary Completion Date : | October 22, 2020 |
| Actual Study Completion Date : | October 22, 2020 |
| Arm | Intervention/treatment |
|---|---|
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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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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) |
- Hemoglobin A1c (HbA1c) [ Time Frame: baseline, month 3 ]Glycated haemoglobin (HbA1c)
- 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
- 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
- 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.
- 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
- 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
- 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
- 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.
- Mean Glucose Level [ Time Frame: baseline, month 3 ]Mean glucose level from continuous glucose monitoring data at baseline and month 3
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161131
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Molly Tanenbaum, PhD | Stanford University |
Documents provided by Molly Tanenbaum, Stanford University:
| Responsible Party: | Molly Tanenbaum, Instructor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT04161131 |
| Other Study ID Numbers: |
47667 K23DK119470 ( U.S. NIH Grant/Contract ) P30DK116074 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 13, 2019 Key Record Dates |
| Results First Posted: | June 8, 2021 |
| Last Update Posted: | September 13, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |