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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK119470 | U.S. NIH Grant/Contract | View source | |
| P30DK116074 | 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 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.
The proposed research will create and refine the ONBOARD intervention for CGM use. Participants will be tracked using metrics of A1c, time in glucose target range, number of days using CGM, blood glucose (BG) downloads, diabetes problem solving, diabetes distress, and technology attitudes. The investigators will examine whether ONBOARD leads to improved diabetes and psychosocial outcomes and sustained CGM use. At the end of this study, the investigators will have created and refined a comprehensive, multicomponent intervention package to promote increased and sustained uptake of CGM and increase readiness for closed loop adoption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONBOARD Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONBOARD | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) | Glycated haemoglobin (HbA1c) | baseline, month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study | The number of participants who withdraw or are lost to followup over the course of the study is used as a measure of attrition | Duration of study participation (up to three months) |
| Number of Eligible Individuals Who Agree to Participate in the Study |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34270351 | Result | Tanenbaum ML, Ngo J, Hanes SJ, Basina M, Buckingham BA, Hessler D, Maahs DM, Mulvaney S, Hood KK. ONBOARD: A Feasibility Study of a Telehealth-Based Continuous Glucose Monitoring Adoption Intervention for Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Dec;23(12):818-827. doi: 10.1089/dia.2021.0198. | |
| 34534592 | Result | Tanenbaum ML, Messer LH, Wu CA, Basina M, Buckingham BA, Hessler D, Mulvaney SA, Maahs DM, Hood KK. Help when you need it: Perspectives of adults with T1D on the support and training they would have wanted when starting CGM. Diabetes Res Clin Pract. 2021 Oct;180:109048. doi: 10.1016/j.diabres.2021.109048. Epub 2021 Sep 14. |
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Participants were recruited through the Stanford Research Database, at the Stanford Endocrinology Clinic, and through online type 1 diabetes social media platforms. 81 participants were screened for eligibility.
Participation was online. Once the participants provided their consent they were prompted to complete baseline surveys and then scheduled to receive the four intervention sessions.
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| ID | Title | Description |
|---|---|---|
| FG000 | ONBOARD Intervention | ONBOARD consists of four 60-minute sessions over 3 months. Each session will target a key barrier to Continuous Glucose Monitor (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. 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the baseline survey and met all eligibility criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Hemoglobin A1c (HbA1c) | Glycated haemoglobin (HbA1c) | Participants with measurement at baseline and month 3 are included in the analysis | Posted | Mean | Standard Deviation | percentage of HbA1c | baseline, month 3 |
|
Up to 5 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 | 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. 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diabetic ketoacidosis (DKA) | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Molly Tanenbaum | 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 | Yes | No | No | Study Protocol | Dec 11, 2019 | May 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2020 | Nov 17, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2020 | Nov 17, 2020 | ICF_002.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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Number of eligible individuals who agree to participate in the study out of all those approached during recruitment |
| During screening visit (up to 50 minutes) |
| Satisfaction With Intervention Survey | Participant-rated Satisfaction Survey: Individual question scores are presented, each was measured on a Likert scale (0-4), higher scores mean more satisfaction. | Month 3 |
| Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL | Baseline and 3-month followup continuous glucose monitor values for percent time spent between 70-180mg/dl | two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months) |
| Diabetes Distress Scale for Type 1 Diabetes | 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 | baseline, month 3 |
| Glucose Monitoring System Satisfaction Survey (GMSS-T1D) | Scale title "Glucose Monitoring System Satisfaction Survey - Type 1 Diabetes" Min:1 Max:5 Higher mean scores mean worse outcome | baseline, month 3 |
| Percentage of CGM Data Downloaded and Available for Analysis | Baseline and 3-month follow-up percentage of continuous glucose monitoring values using data available from device for use in analyses. | two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months) |
| Mean Glucose Level | Mean glucose level from continuous glucose monitoring data at baseline and month 3 | baseline, month 3 |
| Barriers to Diabetes Device Use Survey | 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 | baseline, month 3 |
| Diabetes Technology Attitudes Survey | 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 | Baseline, Month 3 |
| Fear of Hypoglycemia - Worry Survey | 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 | baseline, month 3 |
| Hypoglycemia Confidence Scale | 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 | baseline, month 3 |
| Technology Use For Diabetes Problem Solving Scale | 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 | baseline, month 3 |
| INSPIRE Survey | 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 | baseline, month 3 |
| Frequency of Blood Glucose Monitoring | Frequency will be measured as the number of times a day the participant checks blood glucose level using glucose meter | 3 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Annual Family Income | Count of Participants | Participants |
|
| Currently Using Insulin (%) | Count of Participants | Participants |
|
| Length of insulin pump use | Only 20 participants in the study are insulin pump users | Count of Participants | Participants |
|
| Pump Brand | Only 20 participants in the study are insulin pump users | Count of Participants | Participants |
|
| Currently using CGM | Count of Participants | Participants |
|
| Length of CGM use | Only 23 participants in the study were using a CGM at baseline | Count of Participants | Participants |
|
| CGM brand | Only 23 participants in the study were using a CGM at baseline | Count of Participants | Participants |
|
| Chronic conditions other than diabetes | Participants were ask if they had any other condition(s) (yes/no) besides type 1 diabetes | Count of Participants | Participants |
|
| Frequency of CGM use in the past month (per participant) | Only 23 participants in the study were using a CGM at baseline | Number | participants |
|
|
|
| Secondary | Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study | The number of participants who withdraw or are lost to followup over the course of the study is used as a measure of attrition | Posted | Count of Participants | Participants | Duration of study participation (up to three months) |
|
|
|
| Secondary | Number of Eligible Individuals Who Agree to Participate in the Study | Number of eligible individuals who agree to participate in the study out of all those approached during recruitment | 81 individuals were assessed for eligibility | Posted | Count of Participants | Participants | During screening visit (up to 50 minutes) |
|
|
|
| Secondary | Satisfaction With Intervention Survey | Participant-rated Satisfaction Survey: Individual question scores are presented, each was measured on a Likert scale (0-4), higher scores mean more satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
|
|
|
| Secondary | Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL | Baseline and 3-month followup continuous glucose monitor values for percent time spent between 70-180mg/dl | 19 participants had CGM data available for both measurements | Posted | Mean | Standard Deviation | percentage of time in range | two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months) |
|
|
|
| Secondary | Diabetes Distress Scale for Type 1 Diabetes | 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 | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline, month 3 |
|
|
|
| Secondary | Glucose Monitoring System Satisfaction Survey (GMSS-T1D) | Scale title "Glucose Monitoring System Satisfaction Survey - Type 1 Diabetes" Min:1 Max:5 Higher mean scores mean worse outcome | Participants who completed the protocol and with data for the respective timepoints are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline, month 3 |
|
|
|
| Secondary | Percentage of CGM Data Downloaded and Available for Analysis | Baseline and 3-month follow-up percentage of continuous glucose monitoring values using data available from device for use in analyses. | 19 participants provided CGM data for both measurements | Posted | Mean | Standard Deviation | percentage of CGM wear data available | two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months) |
|
|
|
| Secondary | Mean Glucose Level | Mean glucose level from continuous glucose monitoring data at baseline and month 3 | 20 participants provided mean glucose values at baseline and month 3 | Posted | Mean | Standard Deviation | mg/dL | baseline, month 3 |
|
|
|
| Secondary | Barriers to Diabetes Device Use Survey | 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 | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline, month 3 |
|
|
|
| Secondary | Diabetes Technology Attitudes Survey | 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 | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 3 |
|
|
|
| Secondary | Fear of Hypoglycemia - Worry Survey | 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 | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline, month 3 |
|
|
|
| Secondary | Hypoglycemia Confidence Scale | 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 | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline, month 3 |
|
|
|
| Secondary | Technology Use For Diabetes Problem Solving Scale | 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 | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline, month 3 |
|
|
|
| Secondary | INSPIRE Survey | 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 | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | baseline, month 3 |
|
|
|
| Secondary | Frequency of Blood Glucose Monitoring | Frequency will be measured as the number of times a day the participant checks blood glucose level using glucose meter | Data were not collected for this outcome measure | Posted | 3 months |
|
|
| 0 |
| 28 |
| 2 |
| 28 |
| 0 |
| 28 |
| Ascites | Infections and infestations | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
|
| Q4. I would recommend the ONBOARD program |
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| Q5. Overall, how satisfied were you with the number of sessions? |
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| Q6. Overall, how satisfied were you with the length of the sessions? |
|