Trial Outcomes & Findings for Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial (NCT NCT04672655)
NCT ID: NCT04672655
Last Updated: 2025-09-05
Results Overview
Glycated hemoglobin
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
baseline, month 3, month 6, month 12
Results posted on
2025-09-05
Participant Flow
150 patients signed informed consent; of these, 138 completed the baseline survey, and 135 were randomized.
Participant milestones
| Measure |
ONBOARD Intervention Group
Those randomized to the ONBOARD group receive 12 weeks of continuous glucose monitor (CGM) supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.
|
CGM Only Group
Those randomized to the CGM Only group do not receive the ONBOARD intervention during their 12-month participation in the study. They only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
|
Overall Study
Met Eligibility Criteria
|
67
|
67
|
|
Overall Study
Completed 3 Months
|
61
|
60
|
|
Overall Study
Completed 6 Months
|
57
|
54
|
|
Overall Study
COMPLETED
|
54
|
50
|
|
Overall Study
NOT COMPLETED
|
14
|
17
|
Reasons for withdrawal
| Measure |
ONBOARD Intervention Group
Those randomized to the ONBOARD group receive 12 weeks of continuous glucose monitor (CGM) supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.
|
CGM Only Group
Those randomized to the CGM Only group do not receive the ONBOARD intervention during their 12-month participation in the study. They only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
17
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Withdrawal by Study
|
1
|
0
|
Baseline Characteristics
Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
Baseline characteristics by cohort
| Measure |
ONBOARD Intervention Group
n=67 Participants
Those randomized to the ONBOARD group receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.
|
CGM Only Group
n=67 Participants
Those randomized to the CGM Only group do not receive the ONBOARD intervention during their 12-month participation in the study. They only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.50 years
STANDARD_DEVIATION 8.87 • n=5 Participants
|
34.86 years
STANDARD_DEVIATION 7.92 • n=7 Participants
|
34.68 years
STANDARD_DEVIATION 8.38 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-binary
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Hemoglobin A1c (HbA1c)
|
8.20 Percentage of Glycated Hemoglobin
STANDARD_DEVIATION 1.78 • n=5 Participants
|
7.85 Percentage of Glycated Hemoglobin
STANDARD_DEVIATION 1.96 • n=7 Participants
|
8.03 Percentage of Glycated Hemoglobin
STANDARD_DEVIATION 1.87 • n=5 Participants
|
|
Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)
|
2.5 Score on a scale
STANDARD_DEVIATION 0.87 • n=5 Participants
|
2.48 Score on a scale
STANDARD_DEVIATION 0.82 • n=7 Participants
|
2.49 Score on a scale
STANDARD_DEVIATION 0.84 • n=5 Participants
|
|
Percent Time in Glucose Target Range
|
0.58 Percentage of time
STANDARD_DEVIATION 0.19 • n=5 Participants
|
0.61 Percentage of time
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.59 Percentage of time
STANDARD_DEVIATION 0.19 • n=5 Participants
|
|
Percent CGM Wear Time
|
12.28 Percentage of time
STANDARD_DEVIATION 2.09 • n=5 Participants
|
12.18 Percentage of time
STANDARD_DEVIATION 2.01 • n=7 Participants
|
12.23 Percentage of time
STANDARD_DEVIATION 2.04 • n=5 Participants
|
|
Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)
|
3.31 Score on a scale
STANDARD_DEVIATION 0.63 • n=5 Participants
|
3.19 Score on a scale
STANDARD_DEVIATION 0.62 • n=7 Participants
|
3.25 Score on a scale
STANDARD_DEVIATION 0.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, month 3, month 6, month 12Population: Participants with data at each respective time point
Glycated hemoglobin
Outcome measures
| Measure |
ONBOARD Intervention Group
n=53 Participants
Those randomized to the ONBOARD group receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.
|
CGM Only Group
n=57 Participants
Those randomized to the CGM Only group do not receive the ONBOARD intervention during their 12-month participation in the study. They only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.
|
|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) Over Time
Change at Month 3
|
-0.34 percentage of glycated hemoglobin
Interval -0.61 to -0.06
|
-0.53 percentage of glycated hemoglobin
Interval -0.8 to -0.26
|
|
Change in Hemoglobin A1c (HbA1c) Over Time
Change at Month 6
|
-0.34 percentage of glycated hemoglobin
Interval -0.61 to -0.06
|
-0.51 percentage of glycated hemoglobin
Interval -0.79 to -0.23
|
|
Change in Hemoglobin A1c (HbA1c) Over Time
Change at Month 12
|
-0.21 percentage of glycated hemoglobin
Interval -0.49 to -0.07
|
-0.48 percentage of glycated hemoglobin
Interval -0.76 to -0.19
|
SECONDARY outcome
Timeframe: baseline, month 3, month 6, month 12Population: Participants with data at each respective time point
14 days of CGM data were used to calculate the change in the percentage glucose readings from CGM system between 70-180 mg/dL per unit of time at each time point. All time points taken together are needed to evaluate this outcome measure.
Outcome measures
| Measure |
ONBOARD Intervention Group
n=51 Participants
Those randomized to the ONBOARD group receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.
|
CGM Only Group
n=57 Participants
Those randomized to the CGM Only group do not receive the ONBOARD intervention during their 12-month participation in the study. They only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.
|
|---|---|---|
|
Change in Time in Glucose Target Range
Change at month 3
|
-0.03 percentage of time in range
Interval -0.07 to 0.01
|
-0.02 percentage of time in range
Interval -0.05 to -0.02
|
|
Change in Time in Glucose Target Range
Change at month 6
|
-0.04 percentage of time in range
Interval -0.08 to 0.0
|
-0.01 percentage of time in range
Interval -0.05 to 0.04
|
|
Change in Time in Glucose Target Range
Change at month 12
|
-0.03 percentage of time in range
Interval -0.07 to -0.01
|
0.00 percentage of time in range
Interval -0.04 to 0.05
|
SECONDARY outcome
Timeframe: baseline, month 3, month 6, month 12Population: Participants with data at each respective time point
14 days of CGM data were used to calculate the change in percentage of time wearing CGM at each time point. All time points taken together are needed to evaluate this outcome measure.
Outcome measures
| Measure |
ONBOARD Intervention Group
n=51 Participants
Those randomized to the ONBOARD group receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.
|
CGM Only Group
n=57 Participants
Those randomized to the CGM Only group do not receive the ONBOARD intervention during their 12-month participation in the study. They only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.
|
|---|---|---|
|
Change in Percent CGM Wear Time
Change at Month 3
|
-0.08 percentage of days wearing CGM
Interval -0.14 to -0.03
|
-0.11 percentage of days wearing CGM
Interval -0.16 to -0.05
|
|
Change in Percent CGM Wear Time
Change at Month 6
|
-0.04 percentage of days wearing CGM
Interval -0.11 to 0.02
|
-0.07 percentage of days wearing CGM
Interval -0.14 to 0.0
|
|
Change in Percent CGM Wear Time
Change at Month 12
|
-0.01 percentage of days wearing CGM
Interval -0.08 to 0.06
|
-0.07 percentage of days wearing CGM
Interval -0.14 to 0.0
|
SECONDARY outcome
Timeframe: baseline, month 3, month 6, month 12Population: Participants with data at each respective time point
The T1-DDS is a 28-item self-report scale that assesses multiple dimensions of diabetes distress. Each item is scored from 1 to 6, then items scores are summed and average to calculate a total score (1 to 6): higher item and total scores indicate more distress (worse outcome). All time points taken together are needed to evaluate this outcome measure
Outcome measures
| Measure |
ONBOARD Intervention Group
n=67 Participants
Those randomized to the ONBOARD group receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.
|
CGM Only Group
n=67 Participants
Those randomized to the CGM Only group do not receive the ONBOARD intervention during their 12-month participation in the study. They only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.
|
|---|---|---|
|
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)
Change at Month 3
|
-0.24 score on a scale
Interval -0.39 to -0.1
|
-0.48 score on a scale
Interval -0.63 to -0.34
|
|
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)
Change at Month 12
|
-0.38 score on a scale
Interval -0.53 to -0.23
|
-0.38 score on a scale
Interval -0.53 to -0.23
|
|
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)
Change at Month 6
|
-0.32 score on a scale
Interval -0.47 to -0.17
|
-0.39 score on a scale
Interval -0.54 to -0.24
|
SECONDARY outcome
Timeframe: baseline, month 3, month 6, month 12Population: Participants with data at each respective time point
The GMSS-T1D is a 15-item self-report scale that assesses attitudes towards one's current glucose monitoring system. Overall score range is 1 to 5: higher total scores indicate greater satisfaction (better outcome). All time points taken together are needed to evaluate this outcome measure
Outcome measures
| Measure |
ONBOARD Intervention Group
n=58 Participants
Those randomized to the ONBOARD group receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.
|
CGM Only Group
n=58 Participants
Those randomized to the CGM Only group do not receive the ONBOARD intervention during their 12-month participation in the study. They only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.
|
|---|---|---|
|
Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)
Change at Month 6
|
0.5 score on a scale
Interval 0.34 to 0.66
|
0.47 score on a scale
Interval 0.32 to 0.63
|
|
Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)
Change at Month 12
|
0.47 score on a scale
Interval 0.32 to 0.63
|
0.41 score on a scale
Interval 0.25 to 0.57
|
|
Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)
Change at Month 3
|
0.61 score on a scale
Interval 0.46 to 0.76
|
0.53 score on a scale
Interval 0.38 to 0.69
|
Adverse Events
ONBOARD Intervention Group
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
CGM Only Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ONBOARD Intervention Group
n=68 participants at risk
Those randomized to the ONBOARD group receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart.
|
CGM Only Group
n=67 participants at risk
Those randomized to the CGM Only group do not receive the ONBOARD intervention during their 12-month participation in the study. They only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/68 • Up to 12 months
|
0.00%
0/67 • Up to 12 months
|
|
Surgical and medical procedures
Appendicitis
|
1.5%
1/68 • Up to 12 months
|
0.00%
0/67 • Up to 12 months
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
1.5%
1/68 • Up to 12 months
|
1.5%
1/67 • Up to 12 months
|
|
Endocrine disorders
Hypoglycemic Episode
|
1.5%
1/68 • Up to 12 months
|
0.00%
0/67 • Up to 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place