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

NCT06848361 | Enrolling By Invitation FDA Device

• 2 other identifiers: STUDY230800531R01DK136788-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 Diabetes Mellitus; Adult; Glucose Monitoring; Mobile Application; Diabetes Self-Management; Activity Tracker; Continuous Glucose Monitoring; Empowerment

Outcome Measures

Primary Outcomes (3)

• Percent of eligible individuals who enroll in the study

  Percent of individuals contacted and found eligible who enroll in the study. The goal benchmark is \>/=60%.

  Pre-baseline

• Percent of days wearable device data is collected

  Percent of days adequate wearable device data is collected during the 4-month intervention. The goal benchmark is \>/=75%.

  From 0 to 4 months

• Percent participants retained in study to the 4-month outcome assessment

  Percent of participants retained in the study through the 4-month outcome assessment. The goal benchmark is \>/=85%.

  From 0 to 4 months

Secondary Outcomes (21)

• Percent of individuals contacted who enroll in the study

  Pre-baseline

• Percent of days self-report data is collected

  From 0 to 4 months

• Percent of weeks participant responds to goal-setting prompts

  From 0 to 4 months

• Participant satisfaction with intervention

  4 months

• Change in hemoglobin A1c

  Baseline vs 4-6 Months

Study Arms (3)

MPowerHub

EXPERIMENTAL

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.

Device: MPowerHub; Device: Continuous Glucose Monitor (CGM); Device: Activity Monitor

Continuous Glucose Monitor (CGM) Only

ACTIVE COMPARATOR

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.

Device: Continuous Glucose Monitor (CGM)

Activity Monitor Only

ACTIVE COMPARATOR

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.

Device: Activity Monitor

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.

MPowerHub

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.

Continuous Glucose Monitor (CGM) Only; MPowerHub

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.

Activity Monitor Only; MPowerHub

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received outpatient care in the participating health system in the last 12 months
• 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

You may not qualify if:

• Originally was diagnosed with type 2 diabetes before the age of 21 years
• 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

Sponsors & Collaborators

• Ann-Marie Rosland: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• The Pittsburgh Foundation: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Empowerment

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Ann-Marie Rosland, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Carissa Low, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 27, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data underlying publication will be made available on the study publication date. Data not used in publications will be prepared for sharing by the completion of the award and will remain available for at least five years.
• Access Criteria: Data requests must be submitted in writing using a structured data request form. All data requests will be reviewed by the Multiple PIs (MPIs) and subject to the join approval of the MPIs and co-investigators prior to sharing. Requesters will be required to sign a data use agreement prior to receiving access to the data. The requesting institution's IRB or equivalent body must approve the requested use. All data sharing will follow institutional policies and local IRB rules, as well as local, state, and Federal laws and regulations including the HIPAA Privacy Rule.

Locations

US (1)