N/A
Completed N=28
Overcoming Barriers and Obstacles to Adopting Diabetes Devices
Source: ClinicalTrials.gov NCT04161131 ↗Enrolled (actual)
28
Serious AEs
7.1%
Results posted
Jun 2021
Primary outcomePrimary: Hemoglobin A1c (HbA1c) — 7.27; 6.73 percentage of HbA1c
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hemoglobin A1c (HbA1c) |
7.27; 6.73 | — |
| SECONDARY Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study |
6 | — |
| SECONDARY Number of Eligible Individuals Who Agree to Participate in the Study |
28 | — |
| SECONDARY Satisfaction With Intervention Survey |
2.95; 3.5; 3.55; 3.5; 3.32; 3.32 | — |
| SECONDARY Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL |
71.4; 75.1 | — |
| SECONDARY Diabetes Distress Scale for Type 1 Diabetes |
2.27; 2.02 | — |
| SECONDARY Glucose Monitoring System Satisfaction Survey (GMSS-T1D) |
3.88; 3.93 | — |
| SECONDARY Percentage of CGM Data Downloaded and Available for Analysis |
76.4; 81.3 | — |
| SECONDARY Mean Glucose Level |
149.04; 147.03 | — |
| SECONDARY Barriers to Diabetes Device Use Survey |
5.45; 5.5 | — |
| SECONDARY Diabetes Technology Attitudes Survey |
3.97; 4.23 | — |
| SECONDARY Fear of Hypoglycemia - Worry Survey |
.87; .89 | — |
| SECONDARY Hypoglycemia Confidence Scale |
3.43; 3.44 | — |
| SECONDARY Technology Use For Diabetes Problem Solving Scale |
2.36; 2.35 | — |
| SECONDARY INSPIRE Survey |
1.96; 1.92 | — |
| SECONDARY Frequency of Blood Glucose Monitoring |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04161131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.