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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK137803-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Michigan | OTHER |
| San Diego State University |
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This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period.
The objective of REFLECT2D (Real-time Engagement For Learning to Effectively Control Type 2 Diabetes) is to evaluate whether pairing real-time glycemic and health behavior data leads to improved glycemic control among adolescents and young adults with type 2 diabetes. Participants will use a mobile app that integrates continuous glucose monitor data, Fitbit activity tracker data, and diet logging, with the aim of increasing capability to interpret glycemic data (including impacts of physical activity and dietary intake), providing opportunity to plan and implement behavior change, and increasing motivation to engage in health behaviors. After a session with a Registered Dietitian and Diabetes Educator who will support participants in forming diet and activity goals, a 90-day micro-randomized trial (MRT) period will involve once daily randomization of each participant to: 1) physical-activity focused prompt, 2) dietary intake-focused prompt, or 3) no prompt. Prompts will include reviews of glycemic trends in the past 24 hours (e.g., periods of hyperglycemia, max glucose) and will ask participants to use visual summaries of activity or diet and glucose to reflect on and revise their behavioral management goals as needed. After the MRT, a 90-day observation period without prompts but with ongoing availability of continuous glucose monitor data, Fitbit, and Healthmine app will examine persistence of glycemic and behavior changes. In addition to daily micro-randomization, participants will be randomized 1:1 at study start to proactive outreach from the study team in the case of 3 or more days of missing data, versus no outreach for missing data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Focused App Prompt | Experimental | The app prompts will ask participants what went well, or did not go well with their physical activity in the previous 24 hours in relation to their blood glucose numbers. |
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| Diet Focused App Prompt | Experimental | The app prompts will ask participants what went well, or did not go well with their diet in the previous 24 hours in relation to their blood glucose numbers. |
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| No App Prompt | Experimental | No app prompt will be sent to the participant |
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| Outreach for Missing Data | Experimental | Participants will be randomized to receive proactive outreach by the study team in the case of 3 or more days of missing CGM data, versus no proactive outreach |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused App Prompt | Behavioral | Prompts are designed to develop knowledge and self-efficacy in diabetes-related health behaviors (capability). The paired glycemic and behavior data will provide the opportunity to reflect and to plan diet or exercise for the following day (self-reflective motivation). |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose time above 180mg/dL | measured using continuous glucose monitor | daily during micro randomized trial, 90 days |
| Mean daily glucose | measured using continuous glucose monitor; mg/dL | daily during micro randomized trial, 90 days |
| Maximum daily glucose | measured using continuous glucose monitor; mg/dL | daily during micro randomized trial, 90 days |
| Minimum daily glucose | measured using continuous glucose monitor; mg/dL | daily during micro randomized trial, 90 days |
| Glucose coefficient of variability | measured using continuous glucose monitor | daily during micro randomized trial, 90 days |
| Mean amplitude of glycemic excursions | measured using continuous glucose monitor | daily during micro randomized trial, 90 days |
| Hemoglobin A1c | lab-based measure to assess longer-term glycemic control, collected at study visit | through study completion, 6 months average |
| Fasting glucose | lab-based measure to assess glycemic control, collected at study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | weight and height will be combined to report BMI in kg/m^2 | through study completion, 6 months average |
| Diabetes distress | Measured via Problem Areas in Diabetes Scale (PAID-5). Score ranges from 0-20; a total score of 8 or more indicates possible diabetes related emotional distress. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Ellen Vajravelu, MD | Contact | 412-692-6533 | vajravelume@upmc.edu | |
| Margaret Zupa, MD | Contact | zupamf@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary Ellen Vajravelu, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, appendices)
Beginning 3 months and ending 5 years following article publication
proposals should be directed to vajravelume@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| Emory University | OTHER |
Subjects will wear a continuous glucose monitor and activity watch for study duration. Subjects will be micro-randomized once daily for 90 days to receive app prompts regarding nutrition or physical activity.
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| No App Prompt | Behavioral | No app prompts are designed to assess whether health behaviors are affected without being prompted to reflect and change those behaviors related to glycemic control. |
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| Outreach for Missing Data | Behavioral | For participants randomized to proactive outreach, after 3 or more days of missing CGM data, the study team will reach out to participants by phone and/or text message to troubleshoot and support participants in re-connecting with CGM and apps. For participants randomized to not receive proactive outreach, participants will be instructed to reach out to the study team at their discretion when help is needed related to CGM or app connection. |
|
| through study completion, 6 months average |
| Objective physical activity (step count) | step count measured using the Fitbit physical activity tracker | daily during micro randomized trial, 90 days; |
| Objective physical activity (moderate-vigorous physical activity) | moderate-vigorous physical activity (>100 steps per minute) will be measured using Fitbit activity tracker | daily during micro randomized trial, 90 days; |
| Self-reported physical activity | assessed using PACE+ Adolescent Physical Activity Measure (PACE+) questionnaire to determine days with at least 60 minutes of moderate-vigorous physical activity per week. score ranges from 0-14; lower scores indicate less achievement of physical activity guidelines | through study completion, 6 months average |
| Diet quality | 24-hour dietary recall will be collected by study staff, who will use the Automated Self Administered 24 Hour Dietary Recall Assessment Tool (ASA24) to record data for diet quality assessment | through study completion, 6 months average |
| Capability | Assessed via the Diabetes Empowerment Scale (DES), a measure of self-efficacy. Average score ranges from 28-140; higher scores indicate greater diabetes empowerment | through study completion, 6 months average |
| Healthmine app use | Percent of days with app use, per study period will be determined. | during microrandomized trial, observational period |
| Continuous glucose monitor use use | Defined as percent of days with CGM data available, per study period. | during microrandomized trial, observational period |
| Motivation to engage in diabetes self-management | Measured via Treatment Self-Regulation Questionnaire (TSRQ). score ranges from 15-105; scoring is based on and average between subscales of intrinsic vs. extrinsic motivation. | through study completion, 6 months average |
| through study completion; 6 months average |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |