Diabetes Mellitus, Type 2, Hyperglycemia, Lifestyle, Physical Inactivity
Conditions
Brief summary
The goal of this clinical trial is to learn if a new smartphone app that pairs glucose and exercise data will help adolescents and young adults with type 2 diabetes improve glycemic control. It will also study how changes in glycemic control are maintained over time. The main questions it aims to answer are: * Does using the app help with short-term glycemic control? * Does using the app help with longer-term glycemic control? * Does using the app help increase physical activity? Participants will: * Wear a continuous glucose monitoring device for 6 months * Wear a physical activity tracker for 6 months * Use the study smartphone app for 6 months * Complete 3 in-person study visits with fasting blood draws * Report dietary intake intermittently throughout the study
Detailed description
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 an initial educational session and run-in period, 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. 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.
Interventions
BEHAVIORALFocused App Prompt
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).
BEHAVIORALNo App Prompt
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.
Sponsors
University of Pittsburgh
Dartmouth College
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
San Diego State University
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 26 Years
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes * English-speaking (app in English)
Exclusion criteria
* Current pregnancy * Hydroxyurea use (CGM sensor inaccuracies) * Cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management * Current or previously diagnosed eating disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose time above 180mg/dL | daily during micro randomized trial, 90 days | measured using continuous glucose monitor |
| Mean daily glucose | daily during micro randomized trial, 90 days | measured using continuous glucose monitor; mg/dL |
| Maximum daily glucose | daily during micro randomized trial, 90 days | measured using continuous glucose monitor; mg/dL |
| Minimum daily glucose | daily during micro randomized trial, 90 days | measured using continuous glucose monitor; mg/dL |
| Glucose coefficient of variability | daily during micro randomized trial, 90 days | measured using continuous glucose monitor |
| Mean amplitude of glycemic excursions | daily during micro randomized trial, 90 days | measured using continuous glucose monitor |
| Hemoglobin A1c | through study completion, 6 months average | lab-based measure to assess longer-term glycemic control, collected at study visit |
| Fasting glucose | through study completion, 6 months average | lab-based measure to assess glycemic control, collected at study visit |
| Objective physical activity (step count) | daily during micro randomized trial, 90 days; | step count measured using the Fitbit physical activity tracker |
| Objective physical activity (moderate-vigorous physical activity) | daily during micro randomized trial, 90 days; | moderate-vigorous physical activity (\>100 steps per minute) will be measured using Fitbit activity tracker |
| Self-reported physical activity | through study completion, 6 months average | 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 |
| Diet quality | through study completion, 6 months average | 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 |
| Capability | through study completion, 6 months average | Assessed via the Diabetes Empowerment Scale (DES), a measure of self-efficacy. Average score ranges from 28-140; higher scores indicate greater diabetes empowerment |
| Healthmine app use | during microrandomized trial, observational period | Percent of days with app use, per study period will be determined. |
| Continuous glucose monitor use use | during microrandomized trial, observational period | Defined as percent of days with CGM data available, per study period. |
| Motivation to engage in diabetes self-management | through study completion, 6 months average | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | through study completion, 6 months average | weight and height will be combined to report BMI in kg/m\^2 |
| Diabetes distress | through study completion; 6 months average | 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. |
Countries
United States
Contacts
CONTACTMary Ellen Vajravelu, MD
CONTACTMargaret Zupa, MD
PRINCIPAL_INVESTIGATORMary Ellen Vajravelu, MD
University of Pittsburgh
Outcome results
None listed