Pilot-Testing Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes

Browse trials for

• Diabetes Mellitus, Type 2 10,371
• Hyperglycemia 800
• Sedentary Behavior 1,273
• Motor Activity 9,798

Keywords

• adolescent
• young adult
• type 2 diabetes
• CGM

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Study arms

• Experimental
  Single-arm pilot study

  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.

  Other: Healthmine app

Interventions

• OtherHealthmine app

  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.

Primary outcomes

1. 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.

   Time frame: 15 days and 30 days after starting study-provided CGM and Healthmine app use

Secondary outcomes

1. 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.

   Time frame: 30-day CGM wear period

2. Days with Fitbit data

   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.

   Time frame: 30-day Fitbit wear period

3. Mean CGM glucose

   Mean glucose obtained from study-provided CGM

   Time frame: 30-day CGM wear period

4. Step count

   Step count data will be obtained via study-provided Fitbit.

   Time frame: 30-day Fitbit wear period

5. 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.

   Time frame: Baseline and 30 days (change from baseline to 30 days)

6. 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.

   Time frame: Baseline and 30 days (change from baseline to 30 days)

7. 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.

   Time frame: Baseline and 30 days (change from baseline to 30 days)

8. 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.

   Time frame: Baseline and 30 days (change from baseline to 30 days)

9. 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.

   Time frame: 30 days (following CGM wear period)

10. 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.

    Time frame: 30-day CGM wear period

11. Glucose time below range

    Percent of time with CGM glucose less than 70 mg/dL

    Time frame: 30-day CGM wear period

12. Glucose time in range

    Percent of time with CGM glucose 70-180 mg/dL

    Time frame: 30-day CGM wear period

13. Glucose time above range

    Percent of time with CGM glucose above 180 mg/dL

    Time frame: 30-day CGM wear period

14. 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.

    Time frame: 30-day CGM wear period

Individual participant data

Plan to share: No