Real-time Engagement for Learning to Effectively Control Type 2 Diabetes

NCT06375460 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY240201411R01DK137803-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Lifestyle; Hyperglycemia; Physical Inactivity

Outcome Measures

Primary Outcomes (16)

• 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

  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

Secondary Outcomes (2)

• Body Mass Index (BMI)

  through study completion, 6 months average

• Diabetes distress

  through study completion; 6 months average

Study Arms (4)

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.

Behavioral: Focused App Prompt

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.

Behavioral: Focused App Prompt

No App Prompt

EXPERIMENTAL

No app prompt will be sent to the participant

Behavioral: No App Prompt

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

Behavioral: Outreach for Missing Data

Interventions

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).

Diet Focused App Prompt; Physical Activity Focused App Prompt

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.

No App Prompt

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.

Outreach for Missing Data

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
• HbA1c ≥7.0%, stable medication use
• HbA1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use
• English-speaking (app in English)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Dartmouth College: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Michigan: collaborator
• San Diego State University: collaborator
• Emory University: collaborator

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Sedentary Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Mary Ellen Vajravelu, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Ellen Vajravelu, MD

CONTACT

412-692-6533; vajravelume@upmc.edu

Margaret Zupa, MD

CONTACT

zupamf@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 19, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: 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

Locations

US (1)