Clinical trial NCT06375460: Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
Official title: Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lifestyle
Hyperglycemia
Physical Inactivity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Dartmouth College
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of Michigan
name: San Diego State University
First posted: 2024-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
* HbA1c ≥7.0%, stable medication use (≥3 months)
* HbA1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use (≥3 months)
* 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

Primary outcomes:
measure: Glucose time above 180mg/dL
timeFrame: daily during micro randomized trial, 90 days
measure: Mean daily glucose
timeFrame: daily during micro randomized trial, 90 days
measure: Maximum daily glucose
timeFrame: daily during micro randomized trial, 90 days
measure: Minimum daily glucose
timeFrame: daily during micro randomized trial, 90 days
measure: Glucose coefficient of variability
timeFrame: daily during micro randomized trial, 90 days
measure: Mean amplitude of glycemic excursions
timeFrame: daily during micro randomized trial, 90 days
measure: Hemoglobin A1c
timeFrame: through study completion, 6 months average
measure: Fasting glucose
timeFrame: through study completion, 6 months average
measure: Objective physical activity (step count)
timeFrame: daily during micro randomized trial, 90 days;
measure: Objective physical activity (moderate-vigorous physical activity)
timeFrame: daily during micro randomized trial, 90 days;
measure: Self-reported physical activity
timeFrame: through study completion, 6 months average
measure: Diet quality
timeFrame: through study completion, 6 months average
measure: Capability
timeFrame: through study completion, 6 months average
measure: Healthmine app use
timeFrame: during microrandomized trial, observational period
measure: Continuous glucose monitor use use
timeFrame: during microrandomized trial, observational period
measure: Motivation to engage in diabetes self-management
timeFrame: through study completion, 6 months average
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: through study completion, 6 months average
measure: Diabetes distress
timeFrame: through study completion; 6 months average
measure: Diabetes family support and conflict
timeFrame: through study completion; 6 months average
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Mary Ellen Vajravelu, MD
role: PRINCIPAL_INVESTIGATOR
References: