Type 1 Diabetes
Conditions
Brief summary
This study is a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with 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
The investigators will enroll 178 adults with T1D between 18-50 years of age. Participants must not have been using CGM regularly for past 6 months. Once consented and enrolled, baseline demographic and psychosocial data will be obtained. Participants will receive 12 weeks of CGM supplies at no cost to them and provided with initial standard CGM introduction and education. Participants will then be randomized to receive ONBOARD or CGM-only. Those randomized to the ONBOARD condition will schedule 4 60-minute sessions with study interventionist (every 2 weeks). Hemoglobin A1c values, CGM usage data, and psychosocial data will be collected at baseline, 3-months (post-intervention), and 6- and 12-months post-baseline.
Interventions
BEHAVIORALONBOARD
Session 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM & social situations; Session 4: Building trust with your CGM
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Molly Tanenbaum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will then be randomized to receive ONBOARD or CGM-only. Those randomized to the ONBOARD condition will schedule 4 60-minute sessions with study interventionist (every 3 weeks).
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is age 18-50 years at time of enrollment 2. Subject must not have been using CGM regularly for past 6 months 3. Subject has a clinical diagnosis of type 1 diabetes 4. Subject comprehends spoken and written English
Exclusion criteria
1. Subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol. 2. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) Over Time | baseline, month 3, month 6, month 12 | Glycated hemoglobin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in Glucose Target Range | baseline, month 3, month 6, month 12 | 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. |
| Change in Percent CGM Wear Time | baseline, month 3, month 6, month 12 | 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. |
| Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) | baseline, month 3, month 6, month 12 | 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 |
| Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) | baseline, month 3, month 6, month 12 | 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 |
Countries
United States
Participant flow
Pre-assignment details
150 patients signed informed consent; of these, 138 completed the baseline survey, and 135 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| ONBOARD Intervention Group 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. | 67 |
| 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. | 67 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 17 |
| Overall Study | Withdrawal by Study | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | ONBOARD Intervention Group | CGM Only Group |
|---|---|---|---|
| Age, Continuous | 34.68 years STANDARD_DEVIATION 8.38 | 34.50 years STANDARD_DEVIATION 8.87 | 34.86 years STANDARD_DEVIATION 7.92 |
| Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) | 2.49 Score on a scale STANDARD_DEVIATION 0.84 | 2.5 Score on a scale STANDARD_DEVIATION 0.87 | 2.48 Score on a scale STANDARD_DEVIATION 0.82 |
| Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) | 3.25 Score on a scale STANDARD_DEVIATION 0.63 | 3.31 Score on a scale STANDARD_DEVIATION 0.63 | 3.19 Score on a scale STANDARD_DEVIATION 0.62 |
| Hemoglobin A1c (HbA1c) | 8.03 Percentage of Glycated Hemoglobin STANDARD_DEVIATION 1.87 | 8.20 Percentage of Glycated Hemoglobin STANDARD_DEVIATION 1.78 | 7.85 Percentage of Glycated Hemoglobin STANDARD_DEVIATION 1.96 |
| Percent CGM Wear Time | 12.23 Percentage of time STANDARD_DEVIATION 2.04 | 12.28 Percentage of time STANDARD_DEVIATION 2.09 | 12.18 Percentage of time STANDARD_DEVIATION 2.01 |
| Percent Time in Glucose Target Range | 0.59 Percentage of time STANDARD_DEVIATION 0.19 | 0.58 Percentage of time STANDARD_DEVIATION 0.19 | 0.61 Percentage of time STANDARD_DEVIATION 0.2 |
| Race/Ethnicity, Customized Asian | 9 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic/Latinx | 6 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized More than one | 10 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 101 Participants | 49 Participants | 52 Participants |
| Region of Enrollment United States | 134 Participants | 67 Participants | 67 Participants |
| Sex/Gender, Customized Female | 103 Participants | 54 Participants | 49 Participants |
| Sex/Gender, Customized Male | 30 Participants | 13 Participants | 17 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 67 |
| other Total, other adverse events | 0 / 68 | 0 / 67 |
| serious Total, serious adverse events | 4 / 68 | 1 / 67 |
Outcome results
Primary
Change in Hemoglobin A1c (HbA1c) Over Time
Glycated hemoglobin
Time frame: baseline, month 3, month 6, month 12
Population: Participants with data at each respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| ONBOARD Intervention Group | Change in Hemoglobin A1c (HbA1c) Over Time | Change at Month 3 | -0.34 percentage of glycated hemoglobin |
| ONBOARD Intervention Group | Change in Hemoglobin A1c (HbA1c) Over Time | Change at Month 6 | -0.34 percentage of glycated hemoglobin |
| ONBOARD Intervention Group | Change in Hemoglobin A1c (HbA1c) Over Time | Change at Month 12 | -0.21 percentage of glycated hemoglobin |
| CGM Only Group | Change in Hemoglobin A1c (HbA1c) Over Time | Change at Month 3 | -0.53 percentage of glycated hemoglobin |
| CGM Only Group | Change in Hemoglobin A1c (HbA1c) Over Time | Change at Month 6 | -0.51 percentage of glycated hemoglobin |
| CGM Only Group | Change in Hemoglobin A1c (HbA1c) Over Time | Change at Month 12 | -0.48 percentage of glycated hemoglobin |
Comparison: A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.p-value: 0.8875linear mixed effects models
Secondary
Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)
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
Time frame: baseline, month 3, month 6, month 12
Population: Participants with data at each respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| ONBOARD Intervention Group | Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) | Change at Month 3 | -0.24 score on a scale |
| ONBOARD Intervention Group | Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) | Change at Month 6 | -0.32 score on a scale |
| ONBOARD Intervention Group | Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) | Change at Month 12 | -0.38 score on a scale |
| CGM Only Group | Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) | Change at Month 3 | -0.48 score on a scale |
| CGM Only Group | Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) | Change at Month 6 | -0.39 score on a scale |
| CGM Only Group | Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS) | Change at Month 12 | -0.38 score on a scale |
Comparison: A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.p-value: 0.0406linear mixed effects models
Secondary
Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)
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
Time frame: baseline, month 3, month 6, month 12
Population: Participants with data at each respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| ONBOARD Intervention Group | Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) | Change at Month 3 | 0.61 score on a scale |
| ONBOARD Intervention Group | Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) | Change at Month 6 | 0.5 score on a scale |
| ONBOARD Intervention Group | Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) | Change at Month 12 | 0.47 score on a scale |
| CGM Only Group | Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) | Change at Month 3 | 0.53 score on a scale |
| CGM Only Group | Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) | Change at Month 6 | 0.47 score on a scale |
| CGM Only Group | Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D) | Change at Month 12 | 0.41 score on a scale |
Comparison: A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.p-value: 0.9032linear mixed effects models
Secondary
Change in Percent CGM Wear Time
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.
Time frame: baseline, month 3, month 6, month 12
Population: Participants with data at each respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| ONBOARD Intervention Group | Change in Percent CGM Wear Time | Change at Month 3 | -0.08 percentage of days wearing CGM |
| ONBOARD Intervention Group | Change in Percent CGM Wear Time | Change at Month 6 | -0.04 percentage of days wearing CGM |
| ONBOARD Intervention Group | Change in Percent CGM Wear Time | Change at Month 12 | -0.01 percentage of days wearing CGM |
| CGM Only Group | Change in Percent CGM Wear Time | Change at Month 3 | -0.11 percentage of days wearing CGM |
| CGM Only Group | Change in Percent CGM Wear Time | Change at Month 6 | -0.07 percentage of days wearing CGM |
| CGM Only Group | Change in Percent CGM Wear Time | Change at Month 12 | -0.07 percentage of days wearing CGM |
Comparison: A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.p-value: 0.754linear mixed effects models
Secondary
Change in Time in Glucose Target Range
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.
Time frame: baseline, month 3, month 6, month 12
Population: Participants with data at each respective time point
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| ONBOARD Intervention Group | Change in Time in Glucose Target Range | Change at month 3 | -0.03 percentage of time in range |
| ONBOARD Intervention Group | Change in Time in Glucose Target Range | Change at month 6 | -0.04 percentage of time in range |
| ONBOARD Intervention Group | Change in Time in Glucose Target Range | Change at month 12 | -0.03 percentage of time in range |
| CGM Only Group | Change in Time in Glucose Target Range | Change at month 3 | -0.02 percentage of time in range |
| CGM Only Group | Change in Time in Glucose Target Range | Change at month 6 | -0.01 percentage of time in range |
| CGM Only Group | Change in Time in Glucose Target Range | Change at month 12 | 0.00 percentage of time in range |
Comparison: A linear mixed effects model (LMM) was used to examine outcomes measured at 3, 6, and 12 months. An unstructured covariance matrix was specified to model within-subject correlations across repeated measurements. To address missing data, the LMM utilized a likelihood-based approach under the missing-at-random (MAR) assumption, which incorporates all available data, thereby minimizing bias from incomplete follow-up measurements.p-value: 0.4811linear mixed effects models