Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK137803-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| San Diego State University | OTHER |
| Emory University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Michigan |
Not provided
Not provided
Not provided
Not provided
The goal of this study is to pilot test features of a new smartphone app and to gather feedback related to wearing a continuous glucose monitor (CGM) and a Fitbit device, as well as to obtain input on health behavior-focused messages delivered through the app. The study will enroll English-speaking participants aged 16-24 years who were diagnosed with type 2 diabetes before age 18. Participants will be asked to fill out surveys about diabetes, physical activity, and diet before and after wearing a CGM for 30 days. At the end of wearing the CGM, participants will complete an interview about their experience.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm pilot study | Experimental | Participants will engage in pilot-testing a novel smartphone app supporting health behavior change and wear a continuous glucose monitoring device and Fitbit physical activity tracker for 30 days. Questionnaires and interviews will be used to gather participant experiences with the app and device wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthmine app | Other | Participants will wear study-provided continuous glucose monitoring device and Fitbit physical activity tracker for 30 consecutive days. During the same period, they will use an investigator-developed smartphone app (Healthmine), which is being developed to pair CGM and Fitbit data. Participants will receive up to one message about health behavior change (e.g., physical activity, nutrition) daily and will be able to use Healthmine to log exercise and dietary intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of Healthmine app | Assessed via the System Usability Scale (SUS), a 10-item questionnaire measuring perceived usability of a system or technology. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The total SUS score is calculated by summing the score contributions from each item (for odd-numbered items, subtract 1 from the user response; for even-numbered items, subtract the user response from 5), multiplying the sum by 2.5, resulting in a score ranging from 0 to 100. Higher scores indicate better perceived usability, with scores above 68 considered above average usability. | 15 days and 30 days after starting study-provided CGM and Healthmine app use |
| Measure | Description | Time Frame |
|---|---|---|
| Days with CGM data | The number of days with continuous glucose monitoring data available will be divided by the total number of requested days of wear (30) to obtain percentage of days with data. | 30-day CGM wear period |
| Days with Fitbit data |
Not provided
Inclusion criteria:
Exclusion Criteria:
• Cognitive impairment or severe psychiatric conditions that could interfere with participation in behavioral intervention for diabetes self-management
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Ellen Vajravelu, MD, MSHP | Contact | 4126926533 | maryellen.vajravelu@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary Ellen Vajravelu, MD, MSHP | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Dartmouth College | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
The number of days with Fitbit data available will be divided by the total number of requested days of wear (30) to obtain percentage of days with data.
| 30-day Fitbit wear period |
| Mean CGM glucose | Mean glucose obtained from study-provided CGM | 30-day CGM wear period |
| Step count | Step count data will be obtained via study-provided Fitbit. | 30-day Fitbit wear period |
| Diabetes Self-Management | Assessed via the Diabetes Self-Management Questionnaire (DSMQ), a 16-item self-report questionnaire measuring diabetes self-care activities associated with glycemic control. Each item is rated on a 4-point Likert scale (0 = "does not apply to me" to 3 = "applies to me very much"). Items are summed (after reverse-coding negatively worded items) and transformed to a 0-10 scale, where higher scores indicate better self-management. | Baseline and 30 days (change from baseline to 30 days) |
| Treatment Self-Regulation | Assessed via the Treatment Self-Regulation Questionnaire (TSRQ), a questionnaire measuring the degree to which a person's motivation for health behaviors is relatively autonomous (self-determined) versus controlled (motivated by external factors). Items are rated on a 7-point Likert scale (1 = "not at all true" to 7 = "very true"). The TSRQ yields subscale scores for autonomous regulation, controlled regulation, and amotivation, with higher scores on each subscale indicating greater levels of that type of motivation. | Baseline and 30 days (change from baseline to 30 days) |
| Self-Reported Physical Activity | Assessed via the PACE+ Physical Activity Measure, a brief self-report questionnaire measuring physical activity levels. Participants report the number of days per week they engage in moderate or vigorous physical activity for at least 30 minutes (or 60 minutes for adolescents). The measure yields separate scores for moderate and vigorous activity (each ranging from 0-7 days per week), with higher scores indicating greater physical activity frequency. | Baseline and 30 days (change from baseline to 30 days) |
| Diet Quality | Assessed via the Prime Diet Quality Score (PDQS), a food-based dietary assessment tool that evaluates diet quality across 15 food group components. The PDQS includes 10 adequacy components (dark green leafy vegetables, cruciferous vegetables, carrots, other vegetables, citrus fruits, other fruits, fish/seafood, eggs, whole grains, and low-fat dairy) and 5 moderation components (red meat as main dish, processed meat, refined grains and baked goods, sugar-sweetened beverages, and fried foods). Each component is scored based on consumption frequency, with higher scores indicating greater intake of health-promoting foods and lower intake of foods that should be consumed in moderation. The total PDQS ranges from 0-30, with higher scores indicating better overall diet quality. | Baseline and 30 days (change from baseline to 30 days) |
| Glucose monitoring satisfaction | Assessed via the Glucose Monitoring Satisfaction Survey (GMSS) for Type 2 Diabetes, a 15-item questionnaire measuring patient satisfaction with their glucose monitoring device. Items are rated on a 5-point Likert scale (1 = "strongly disagree" to 5 = "strongly agree"). The GMSS yields four subscale scores: Openness (items 1, 8, 10, 14), Emotional Burden (items 2, 5, 9, 13), Behavioral Burden (items 3, 6, 11, 15), and Worthwhileness (items 4, 7 [reverse coded], 12). Subscale scores are calculated as the mean of item responses, with higher scores indicating greater openness, greater burden (for burden subscales), and greater worthwhileness, respectively. A total satisfaction score is calculated as the mean of all items after reverse-coding items 2, 3, 5, 6, 7, 9, 11, 13, and 15, with higher total scores indicating greater overall satisfaction with glucose monitoring. | 30 days (following CGM wear period) |
| Glucose coefficient of variation | Based on CGM glucoses, coefficient of variation will be calculated by dividing the standard deviation of glucose readings by the mean glucose level, then multiplying by 100 to get a percentage. | 30-day CGM wear period |
| Glucose time below range | Percent of time with CGM glucose less than 70 mg/dL | 30-day CGM wear period |
| Glucose time in range | Percent of time with CGM glucose 70-180 mg/dL | 30-day CGM wear period |
| Glucose time above range | Percent of time with CGM glucose above 180 mg/dL | 30-day CGM wear period |
| Mean amplitude of glycemic excursions | A measure of glucose variability calculated from CGM data, calculated by dividing the standard deviation of glucose readings by the mean glucose level, then multiplying by 100 to get a percentage. | 30-day CGM wear period |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
Not provided
Not provided