Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Ann-Marie Rosland
Study ID
NCT06848361
Status
Enrolling By Invitation

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
25 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MPowerHub — DEVICE
    The MPowerHub app allows participants to visualize combined trends from a continuous glucose monitor (CGM) and activity monitor as well as daily self-reports in a display that the participant can customize to overlay the behavioral data they would like to compare to intraday and daily glucose data. Summary data will be displayed over time to allow users to identify potential associations between activity, sleep, stress, diet, and medication adherence and time-in-range and blood glucose variability. Participants receive daily prompts to complete five brief questions about daily health behaviors and two weekly goals/action plans and reflections based on motivational interviewing principles.
  • Continuous Glucose Monitor (CGM) — DEVICE
    A CGM is a wearable device that collects frequent data on glucose levels. It includes an integrated sensor that is inserted under the skin and is connected to a small transmitter that automatically sends information to a smart device, allowing the user to track changes in glucose levels.
  • Activity Monitor — DEVICE
    A wearable activity monitor will be used to track activity (e.g., steps) and sleep levels. Data can be viewed on the activity monitor or a smart device.

Study Details

Day-to-day self-management by adults with type 2 diabetes, including glucose monitoring, taking medications, and healthy habits, is essential to avoid diabetes complications, yet, despite the rapidly expanding availability of wearable glucose and activity monitors, successful self-management remains challenging for many. This research aims to develop and test an approach to help adults use their personal diabetes information from wearable devices to achieve and sustain health diabetes self-management, which will reduce diabetes complications, and improve health and quality of life for people with type 2 diabetes.

Key Dates

Start date
Apr 28, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: MPowerHub
    Participants will: 1. Meet with a Diabetes Care and Education Specialist for an initial diabetes self-management education session that will include individualized assessment, education, and coaching on how to set personal diabetes self-management behavior goals and action plans, and follow-up education as needed. 2. Be trained on how to use assigned study devices (MPowerHub, continuous glucose monitor (CGM), and activity tracker). 3. Be asked to use assigned study devices (MPowerHub, CGM, and activity tracker) for 4 months.
  • Active Comparator: Continuous Glucose Monitor (CGM) Only
    Participants will: 1. Meet with a Diabetes Care and Education Specialist for an initial diabetes self-management education session that will include individualized assessment, education, and coaching on how to set personal diabetes self-management behavior goals and action plans, and follow-up education as needed. 2. Be trained on how to use assigned study device (CGM). 3. Be asked to use assigned study device (CGM) for 4 months.
  • Active Comparator: Activity Monitor Only
    Participants will: 1. Meet with a Diabetes Care and Education Specialist for an initial diabetes self-management education session that will include individualized assessment, education, and coaching on how to set personal diabetes self-management behavior goals and action plans, and follow-up education as needed. 2. Be trained on how to use assigned study device (activity tracker). 3. Be asked to use assigned study device (activity tracker) for 4 months.

Primary Outcome Measure

Percent of eligible individuals who enroll in the study [ Time Frame: Pre-baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213-

Find similar trials in Pittsburgh, PA

By research site
University of Pittsburgh· Pittsburgh, PA

Related Studies