Type 1 Diabetes
Conditions
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALONBOARD
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)
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Molly Tanenbaum
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 screening 2. Subject is within first year of continuous glucose monitor use OR has not been using CGM regularly in the 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 |
|---|---|---|
| Hemoglobin A1c (HbA1c) | baseline, month 3 | Glycated haemoglobin (HbA1c) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Eligible Individuals Who Agree to Participate in the Study | During screening visit (up to 50 minutes) | Number of eligible individuals who agree to participate in the study out of all those approached during recruitment |
| Satisfaction With Intervention Survey | Month 3 | Participant-rated Satisfaction Survey: Individual question scores are presented, each was measured on a Likert scale (0-4), higher scores mean more satisfaction. |
| Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL | two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months) | Baseline and 3-month followup continuous glucose monitor values for percent time spent between 70-180mg/dl |
| Diabetes Distress Scale for Type 1 Diabetes | baseline, month 3 | 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 |
| Glucose Monitoring System Satisfaction Survey (GMSS-T1D) | baseline, month 3 | Scale title Glucose Monitoring System Satisfaction Survey - Type 1 Diabetes Min:1 Max:5 Higher mean scores mean worse outcome |
| Percentage of CGM Data Downloaded and Available for Analysis | two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months) | Baseline and 3-month follow-up percentage of continuous glucose monitoring values using data available from device for use in analyses. |
| Mean Glucose Level | baseline, month 3 | Mean glucose level from continuous glucose monitoring data at baseline and month 3 |
| Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study | Duration of study participation (up to three months) | The number of participants who withdraw or are lost to followup over the course of the study is used as a measure of attrition |
| Diabetes Technology Attitudes Survey | Baseline, Month 3 | 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 |
| Fear of Hypoglycemia - Worry Survey | baseline, month 3 | 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 |
| Hypoglycemia Confidence Scale | baseline, month 3 | 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 |
| Technology Use For Diabetes Problem Solving Scale | baseline, month 3 | 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 |
| INSPIRE Survey | baseline, month 3 | 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 |
| Frequency of Blood Glucose Monitoring | 3 months | Frequency will be measured as the number of times a day the participant checks blood glucose level using glucose meter |
| Barriers to Diabetes Device Use Survey | baseline, month 3 | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 2 |
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | ONBOARD Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 31.48 years STANDARD_DEVIATION 8.34 |
| Annual Family Income $101,000 - 125,000 | 5 Participants |
| Annual Family Income $126,000 -150,000 | 1 Participants |
| Annual Family Income $151,000 -175,000 | 3 Participants |
| Annual Family Income >$175,000 | 2 Participants |
| Annual Family Income <$25,000 | 3 Participants |
| Annual Family Income $25,000-50,000 | 2 Participants |
| Annual Family Income $51,000 - 75,000 | 5 Participants |
| Annual Family Income $76,000 - 100,000 | 4 Participants |
| Annual Family Income Unknown/Declined to state | 1 Participants |
| CGM brand Abbott (Freestyle) | 3 Participants |
| CGM brand Dexcom | 19 Participants |
| CGM brand Medtronic | 1 Participants |
| Chronic conditions other than diabetes No | 17 Participants |
| Chronic conditions other than diabetes Yes | 9 Participants |
| Currently using CGM No | 3 Participants |
| Currently using CGM Yes | 23 Participants |
| Currently Using Insulin (%) No | 6 Participants |
| Currently Using Insulin (%) Yes | 20 Participants |
| Education College graduate | 11 Participants |
| Education Graduate degree | 9 Participants |
| Education Some College | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Frequency of CGM use in the past month (per participant) 14 days | 1 participants |
| Frequency of CGM use in the past month (per participant) 15 days | 1 participants |
| Frequency of CGM use in the past month (per participant) 19 days | 1 participants |
| Frequency of CGM use in the past month (per participant) 1 day | 1 participants |
| Frequency of CGM use in the past month (per participant) 21 days | 2 participants |
| Frequency of CGM use in the past month (per participant) 25 days | 1 participants |
| Frequency of CGM use in the past month (per participant) 29 days | 1 participants |
| Frequency of CGM use in the past month (per participant) 30 days | 14 participants |
| Frequency of CGM use in the past month (per participant) 5 days | 1 participants |
| Length of CGM use 0.5-1 year | 10 Participants |
| Length of CGM use <0.5 years | 10 Participants |
| Length of CGM use 1-2 years | 1 Participants |
| Length of CGM use >5 years | 2 Participants |
| Length of insulin pump use 0.5-<1 year | 1 Participants |
| Length of insulin pump use <0.5 year | 3 Participants |
| Length of insulin pump use 1-<2 years | 0 Participants |
| Length of insulin pump use 2-<5 years | 1 Participants |
| Length of insulin pump use >5 years | 15 Participants |
| Marital Status Living with someone | 5 Participants |
| Marital Status Married | 9 Participants |
| Marital Status Separated | 1 Participants |
| Marital Status Single | 11 Participants |
| Pump Brand Insulet | 4 Participants |
| Pump Brand Medtronic | 9 Participants |
| Pump Brand Tandem | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 2 / 28 |
Outcome results
Primary
Hemoglobin A1c (HbA1c)
Glycated haemoglobin (HbA1c)
Time frame: baseline, month 3
Population: Participants with measurement at baseline and month 3 are included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Hemoglobin A1c (HbA1c) | baseline | 7.27 percentage of HbA1c | Standard Deviation 2.18 |
| ONBOARD Intervention | Hemoglobin A1c (HbA1c) | month 3 | 6.73 percentage of HbA1c | Standard Deviation 2 |
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
Time frame: baseline, month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Barriers to Diabetes Device Use Survey | baseline | 5.45 score on a scale | Standard Deviation 2.28 |
| ONBOARD Intervention | Barriers to Diabetes Device Use Survey | month 3 | 5.5 score on a scale | Standard Deviation 2.58 |
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
Time frame: baseline, month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Diabetes Distress Scale for Type 1 Diabetes | baseline | 2.27 score on a scale | Standard Deviation 0.66 |
| ONBOARD Intervention | Diabetes Distress Scale for Type 1 Diabetes | month 3 | 2.02 score on a scale | Standard Deviation 0.6 |
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
Time frame: Baseline, Month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Diabetes Technology Attitudes Survey | baseline | 3.97 score on a scale | Standard Deviation 0.3 |
| ONBOARD Intervention | Diabetes Technology Attitudes Survey | month 3 | 4.23 score on a scale | Standard Deviation 0.61 |
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
Time frame: baseline, month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Fear of Hypoglycemia - Worry Survey | baseline | .87 score on a scale | Standard Deviation 0.47 |
| ONBOARD Intervention | Fear of Hypoglycemia - Worry Survey | month 3 | .89 score on a scale | Standard Deviation 0.49 |
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
Time frame: 3 months
Population: Data were not collected for this outcome measure
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
Time frame: baseline, month 3
Population: Participants who completed the protocol and with data for the respective timepoints are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Glucose Monitoring System Satisfaction Survey (GMSS-T1D) | baseline | 3.88 score on a scale | Standard Deviation 0.56 |
| ONBOARD Intervention | Glucose Monitoring System Satisfaction Survey (GMSS-T1D) | month 3 | 3.93 score on a scale | Standard Deviation 0.44 |
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
Time frame: baseline, month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Hypoglycemia Confidence Scale | baseline | 3.43 score on a scale | Standard Deviation 0.47 |
| ONBOARD Intervention | Hypoglycemia Confidence Scale | month 3 | 3.44 score on a scale | Standard Deviation 0.51 |
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
Time frame: baseline, month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | INSPIRE Survey | baseline | 1.96 score on a scale | Standard Deviation 0.66 |
| ONBOARD Intervention | INSPIRE Survey | month 3 | 1.92 score on a scale | Standard Deviation 0.68 |
Secondary
Mean Glucose Level
Mean glucose level from continuous glucose monitoring data at baseline and month 3
Time frame: baseline, month 3
Population: 20 participants provided mean glucose values at baseline and month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Mean Glucose Level | Baseline | 149.04 mg/dL | Standard Deviation 33.02 |
| ONBOARD Intervention | Mean Glucose Level | month 3 | 147.03 mg/dL | Standard Deviation 35.26 |
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
Time frame: During screening visit (up to 50 minutes)
Population: 81 individuals were assessed for eligibility
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ONBOARD Intervention | Number of Eligible Individuals Who Agree to Participate in the Study | 28 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
Time frame: Duration of study participation (up to three months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ONBOARD Intervention | Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study | 6 Participants |
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.
Time frame: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
Population: 19 participants provided CGM data for both measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Percentage of CGM Data Downloaded and Available for Analysis | Pre-Intervention | 76.4 percentage of CGM wear data available | Standard Deviation 29.6 |
| ONBOARD Intervention | Percentage of CGM Data Downloaded and Available for Analysis | Post-Intervention | 81.3 percentage of CGM wear data available | Standard Deviation 23.4 |
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
Time frame: two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months)
Population: 19 participants had CGM data available for both measurements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL | Pre-intervention | 71.4 percentage of time in range | Standard Deviation 19.4 |
| ONBOARD Intervention | Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL | Post-intervention | 75.1 percentage of time in range | Standard Deviation 20 |
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.
Time frame: Month 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Satisfaction With Intervention Survey | Q1. Overall, how helpful was the ONBOARD program for you? | 2.95 score on a scale | Standard Deviation 0.84 |
| ONBOARD Intervention | Satisfaction With Intervention Survey | Q2.Overall, how satisfied were you with the ONBOARD program? | 3.5 score on a scale | Standard Deviation 0.86 |
| ONBOARD Intervention | Satisfaction With Intervention Survey | Q3.Overall, how satisfied were you with receiving the ONBOARD program online? | 3.55 score on a scale | Standard Deviation 0.86 |
| ONBOARD Intervention | Satisfaction With Intervention Survey | Q4. I would recommend the ONBOARD program | 3.5 score on a scale | Standard Deviation 0.51 |
| ONBOARD Intervention | Satisfaction With Intervention Survey | Q5. Overall, how satisfied were you with the number of sessions? | 3.32 score on a scale | Standard Deviation 0.72 |
| ONBOARD Intervention | Satisfaction With Intervention Survey | Q6. Overall, how satisfied were you with the length of the sessions? | 3.32 score on a scale | Standard Deviation 0.89 |
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
Time frame: baseline, month 3
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONBOARD Intervention | Technology Use For Diabetes Problem Solving Scale | baseline | 2.36 score on a scale | Standard Deviation 0.71 |
| ONBOARD Intervention | Technology Use For Diabetes Problem Solving Scale | month 3 | 2.35 score on a scale | Standard Deviation 0.8 |