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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK119470-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONBOARD Intervention Group | Experimental | Those randomized to the ONBOARD group will receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. They will also receive the intervention which consists of four 60-minute sessions with study interventionist, held 2 weeks apart. |
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| CGM Only Group | No Intervention | Those randomized to the CGM Only group will not receive the ONBOARD intervention during their 12-month participation in the study. They will only receive 12 weeks of CGM supplies and provide hemoglobin A1c values, data downloads, and survey responses during various time points in the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONBOARD | Behavioral | Session 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM & social situations; Session 4: Building trust with your CGM |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) Over Time | Glycated hemoglobin | baseline, month 3, month 6, month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, month 3, month 6, month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Molly Tanenbaum, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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150 patients signed informed consent; of these, 138 completed the baseline survey, and 135 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who met eligibility criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hemoglobin A1c (HbA1c) Over Time | Glycated hemoglobin | Participants with data at each respective time point | Posted | Least Squares Mean | 95% Confidence Interval | percentage of glycated hemoglobin | baseline, month 3, month 6, month 12 |
|
Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | Unrelated to study participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Molly Tanenbaum, PhD | Stanford University | (650) 725-3955 | mollyt@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 11, 2020 | May 12, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2024 | Jan 15, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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).
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| 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. |
| baseline, month 3, month 6, month 12 |
| 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 | baseline, month 3, month 6, month 12 |
| 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 | baseline, month 3, month 6, month 12 |
| Withdrawal by Study |
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| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | Percentage of Glycated Hemoglobin |
|
| 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). | Mean | Standard Deviation | Score on a scale |
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| Percent Time in Glucose Target Range | This characteristic was assessed for 2 weeks prior to the baseline visit. | Mean | Standard Deviation | Percentage of time |
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| Percent CGM Wear Time | This characteristic was assessed for 2 weeks prior to the baseline visit. | Mean | Standard Deviation | Percentage of time |
|
| 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. Each item is scored from 1 to 5, then items scores are summed and average to calculate a total score (1 to 5). Higher item and total scores indicate greater satisfaction (better outcome). | Median | Standard Deviation | Score on a scale |
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| 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. | Participants with data at each respective time point | Posted | Least Squares Mean | 95% Confidence Interval | percentage of time in range | baseline, month 3, month 6, month 12 |
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| 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. | Participants with data at each respective time point | Posted | Least Squares Mean | 95% Confidence Interval | percentage of days wearing CGM | baseline, month 3, month 6, month 12 |
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| 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 | Participants with data at each respective time point | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, month 3, month 6, month 12 |
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|
|
| 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 | Participants with data at each respective time point | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | baseline, month 3, month 6, month 12 |
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|
|
| 0 |
| 68 |
| 4 |
| 68 |
| 0 |
| 68 |
| EG001 | 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. | 0 | 67 | 1 | 67 | 0 | 67 |
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| Appendicitis | Surgical and medical procedures | Non-systematic Assessment | Unrelated to study participation. |
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| Diabetic Ketoacidosis | Endocrine disorders | Non-systematic Assessment | Unrelated to study participation. |
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| Hypoglycemic Episode | Endocrine disorders | Non-systematic Assessment |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Change at month 6 |
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| Change at month 12 |
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| Change at Month 6 |
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| Change at Month 12 |
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| Change at Month 6 |
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| Change at Month 12 |
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| Change at Month 6 |
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| Change at Month 12 |
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