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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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).
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.
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.
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Glucose time above 180mg/dL
measured using continuous glucose monitor
Time frame: daily during micro randomized trial, 90 days
Mean daily glucose
measured using continuous glucose monitor; mg/dL
Time frame: daily during micro randomized trial, 90 days
Maximum daily glucose
measured using continuous glucose monitor; mg/dL
Time frame: daily during micro randomized trial, 90 days
Minimum daily glucose
measured using continuous glucose monitor; mg/dL
Time frame: daily during micro randomized trial, 90 days
Glucose coefficient of variability
measured using continuous glucose monitor
Time frame: daily during micro randomized trial, 90 days
Mean amplitude of glycemic excursions
measured using continuous glucose monitor
Time frame: daily during micro randomized trial, 90 days
Hemoglobin A1c
lab-based measure to assess longer-term glycemic control, collected at study visit
Time frame: through study completion, 6 months average
Fasting glucose
lab-based measure to assess glycemic control, collected at study visit
Time frame: through study completion, 6 months average
Objective physical activity (step count)
step count measured using the Fitbit physical activity tracker
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, 6 months average
Healthmine app use
Percent of days with app use, per study period will be determined.
Time frame: during microrandomized trial, observational period
Continuous glucose monitor use use
Defined as percent of days with CGM data available, per study period.
Time frame: 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.
Time frame: through study completion, 6 months average
Body Mass Index (BMI)
weight and height will be combined to report BMI in kg/m\^2
Time frame: 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.
Time frame: through study completion; 6 months average
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