Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
NCT ID: NCT06848361
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
80 participants
INTERVENTIONAL
2025-04-28
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
MPowerHub
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)
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
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.
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.
Continuous Glucose Monitor (CGM)
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 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.
Activity Monitor
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.
Interventions
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MPowerHub
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)
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
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.
Eligibility Criteria
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Inclusion Criteria
* Has a diagnosis of type 2 diabetes mellitus (ICD10 codes E08.xx, E09.xx, E11.xx, E13.xx,O24.1x , O24.3x, O24.8x, O24.9x)
* Last Hemoglobin A1c (HbA1c) value obtained in the last 6 months was ≥7.5%
* Currently prescribed at least one non-insulin diabetes medication
* Able to provide informed consent
* Able to interact with a simple smartphone application
* Owns or has access to a smartphone that is able to access an internet website
* Did not participate a prior study related to this protocol
Exclusion Criteria
* Has a diagnosis of type 1 diabetes mellitus
* Has a diagnosis of gestational diabetes without any other diabetes diagnoses
* Is currently prescribed insulin
* Currently is using a CGM device
* Has a diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder
* Has a life-limiting severe illness (e.g., chronic obstructive pulmonary disease requiring oxygen)
* Is pregnant or planning to become pregnant within the next 6 months
* Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)
* Currently is enrolled in another diabetes management intervention study
25 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The Pittsburgh Foundation
OTHER
Ann-Marie Rosland
OTHER
Responsible Party
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Ann-Marie Rosland
Associate Professor of Medicine
Principal Investigators
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Ann-Marie Rosland, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Carissa Low, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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STUDY23080053
Identifier Type: -
Identifier Source: org_study_id
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