Type 2 Diabetes Mellitus (T2DM)MPowerHubNCT06848361
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
A study testing MPowerHub, Continuous Glucose Monitor (CGM) and Activity Monitor in people with Type 2 Diabetes Mellitus (T2DM), run by Ann-Marie Rosland at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- MPowerHub, Continuous Glucose Monitor (CGM) and Activity Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Empowering Adults With Diabetes: Achieving Self-management Success Through Data-Driven Behavior Change, Pilot Randomized Control Trial
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.
Read the detailed description
MPowerHub trial protocol feasibility will be assessed by randomizing 80 adults with type 2 diabetes and glycemic levels above clinical goals to MPowerHub (MPowerHub platform + continuous glucose monitoring \& activity monitoring), continuous glucose monitor alone, or activity monitor alone for four months. Mixed quantitative and qualitative assessments will examine recruitment, engagement, and retention metrics and feedback. Finally, changes in self-management behaviors (measured using semi-structured interview) and clinic glycemic levels (obtained from participants' electronic health record or finger-stick by study research staff) from pre- to post-monitoring will be compared between arms.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- MPowerHub, Continuous Glucose Monitor (CGM), Activity Monitor
- Keywords
- Type 2 Diabetes Mellitus, Adult, Glucose Monitoring, Mobile Application, Diabetes Self-Management, Activity Tracker, Continuous Glucose Monitoring, Empowerment
- Medical subject headings
- Diabetes Mellitus, Type 2, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPowerHubDevice
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 MonitorDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Activity Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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%.
Measured: From 0 to 4 months
Secondary outcomes (21)
Percent of individuals contacted who enroll in the study
Percent among all individuals approached/contacted who enroll in the study. The goal benchmark is >/=20%.
Measured: Pre-baseline
Percent of days self-report data is collected
Percent of days self-report data is collected from participants in MPowerHub study arm. The goal benchmark is >/=75%.
Measured: From 0 to 4 months
Percent of weeks participant responds to goal-setting prompts
Percent of weeks participants in MPowerHub study arm respond to goal-setting prompts. The goal benchmark is >/=65%.
Measured: From 0 to 4 months
Participant satisfaction with intervention
Study specific Likert-scaled survey item will be used to assess overall intervention satisfaction by participants. Response options range from 1=highly unsatisfied to 5=highly satisfied. Satisfaction will be defined as a rating of 4=satisfied or 5=highly satisfied. The goal benchmark is >/=80% satisfaction for the MPowerHub arm. The results for MPowerHub arm will also be compared to the two other arms.
Measured: 4 months
Change in hemoglobin A1c
Hemoglobin A1c (HbA1c) data will be obtained from participant's electronic health record. The most recent HbA1c value recorded within 0-6 months prior to enrollment will be used for the baseline measure, and the most recent value recorded at 4-6 months post-enrollment will be used for the outcome measure. If no results from routine HbA1c have been recorded during the relevant time period, the outcome HbA1c data will be collected with a National Glycohemoglobin Standardization Program-certified point of care instrument.
Measured: Baseline vs 4-6 Months
Change in diabetes medication regimen
Prescribed diabetes medications will be obtained from the participant's electronic health record. A change in diabetes medication regimen assessed by calculating the change in diabetes medication class, e.g., adding or subtracting a class or classes. The range could be negative to positive (e.g., -2, -1, 0, +1, +2) depending on if and how many classes changes occurred.
Measured: From baseline to 4-6 months
Started on insulin
Prescribed insulin during the course of the intervention will be obtained from the participant's electronic health record and documented as yes/no.
Measured: From baseline to 4-6 months
Change in medication adherence
Medication adherence will be assessed using the self-report Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) scale, which is comprised of 3 items assessing the extent to which participants missed, skipped, or did not take their medication as prescribed during the past 7 days. Possible scores range from 1=none of the time to 5=every time with a lower score indicating a greater degree of adherence. Items are summed and scores are averaged. The higher the score, the greater the nonadherence.
Measured: Baseline vs. 4 Months
Change in healthy eating
Healthy eating will be assessed using the "overall health eating" Summary of Diabetes Self-Care Activities (SDSCA) scale. Participants will be asked how many of the last 7 days have they followed a healthy eating plan (0=no days and 7=all the days). The higher the score, the healthier the eating plan.
Measured: Baseline vs 4 Months
Change in fruit and vegetable intake per day
Change in fruit and vegetable intake will be assessed using the 6-item Behavioral Risk Factor Surveillance System (BRFSS) 2017 Fruit and Vegetable Module. Change in daily frequency of fruit and vegetable intake will be calculated using the BRFSS scoring algorithm.
Measured: Baseline vs 4 months
Change in physical activity
Change in physical activity will be assessed using the International Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF asks respondents to report their frequency and duration of walking, moderate-intensity activity, and vigorous-intensity activity in minutes or hours per day. Our study will score results within each domain separately. Responses will be converted into metabolic equivalent of task (MET) minutes; the higher the MET minutes, the higher the degree of physical activity.
Measured: Baseline vs 4 Months
Change in goal setting
Change in goal setting will be assessed using the Patient Assessment of Chronic Illness Care (PACIC) survey. The PACIC includes three questions about thoughts and actions around setting diabetes goals with 5-point Likert scales (almost never to almost always). Scores will be summed from 3 (all almost never) to 15 (all almost always) and averaged with higher scores reflecting better goal setting.
Measured: Baseline vs 4 months
Change in intrinsic motivation
Change in intrinsic motivation will be assessed using the Treatment Self-Regulation Questionnaire (TSRQ) Concerning Diabetes Scale A. The scale includes 3 questions related to autonomous regulation questions measured through a 7-point Likert scale, where 1 is "not at all true", 4 is "somewhat true", and 7 is "very true". Scores will be summed and divided by the total number of items. The higher the score, the higher the level of autonomous regulation.
Measured: Baseline vs 4 months
Change in extrinsic motivation
Change in extrinsic motivation will be assessed using the Treatment Self-Regulation Questionnaire (TSRQ) Concerning Diabetes Scale A. The scale includes 5 questions related to controlled regulation questions measured through a 7-point Likert scale, where 1 is "not at all true", 4 is "somewhat true", and 7 is "very true". Scores will be summed and divided by the total number of items. The higher the score, the higher the level of controlled regulation.
Measured: Baseline vs 4 months
Change in empowerment
Change in empowerment will be assessed using the Diabetes Empowerment Scale-Short Form (DES-SF). Participants will be asked to respond to 8 questions measured through a 5-point Likert scale (strongly disagree to strongly agree). Scores will be summed and divided by the total number of items. The higher the score indicates a higher level of empowerment.
Measured: Baseline vs 4 months
Change in diabetes distress - overall
Change in overall diabetes distress will be assessed using the Diabetes Distress Scale - 17 (DDS17), which yields a total diabetes distress score. To score, participant's responses to the appropriate items are summed and divided by the number of items in the scale (possible range 1-6). The higher the score indicates a higher level of distress.
Measured: Baseline vs 4 months
Change in diabetes distress - emotional burden
Change in emotional burden will be assessed using the Diabetes Distress Scale - 17 (DDS17), which yields a subscale score addressing emotional burden. To score, participant's responses to the appropriate items are summed and divided by the number of items in the emotional burden subscale, possible range 1-6). The higher the score indicates a higher level of distress.
Measured: Baseline vs 4 months
Change in diabetes distress - regimen distress
Change in regimen distress will be assessed using the Diabetes Distress Scale - 17 (DDS17), which yields a subscale score addressing regimen distress. To score, participant's responses to the appropriate items are summed and divided by the number of items in the regimen distress subscale, possible range 1-6). The higher the score indicates a higher level of distress.
Measured: Baseline vs 4 months
Participant rating of intervention usability
Intervention usability will be assessed using the System Usability Scale. Participants will be asked to respond to 10 questions measured through a 5-point Likert scale (strongly disagree to strongly agree). To score, values are converted to 0 to 4 by subtracting one from odd item scale positions and subtracting the scale position from five for even-numbered items. Converted responses are summed and the total is multiplied by 2.5; the converted range of possible values is from 0 to 100 (with 100 being the most positive response).
Measured: 4 months
Participant perceptions of the benefit of continuous glucose monitoring systems
Perceptions about the benefits of continuous glucose monitoring (CGM) systems will be assessed using the Perceived Benefits of CGM (BenCGM) scale. Participants in the MPowerHub and CGM study arms will be asked 8 questions measured with a 5-point Likert scale (strongly disagree to strongly agree). Item scores are summed and range from 8 (all strongly disagree) to 40 (all strongly agree).
Measured: 4 months
Participant perceptions of the barriers of continuous glucose monitoring systems
Perceptions about the barriers of continuous glucose monitoring (CGM) systems will be assessed using the Perceived Barriers of CGM (BurCGM) scale. Participants in the MPowerHub and CGM study arms will be asked 8 questions measured with a 5-point Likert scale (strongly disagree to strongly agree). Item scores are summed and range from 8 (all strongly disagree) to 40 (all strongly agree).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start28 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann-Marie Rosland
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Pittsburgh Foundation
- Responsible party
- Sponsor-investigator, Ann-Marie Rosland, University of Pittsburgh
- Investigators
- Ann-Marie Rosland, MD, MS, Principal investigator, University of PittsburghCarissa Low, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848361
- Sponsor's protocol ID
- STUDY23080053
- Other IDs
- 1R01DK136788-01A1
- Acronym
- MPowerHub
- Status last verified
- Oct 2026
- First submitted
- 21 Feb 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data derived from the trial will be eligible to be shared. Data sets will include only "limited access data" (i.e., no records with personal identifiers). Data sets will be de-identified prior to distribution, and wearable sensor data will be aggregated at a level that is determined to preserve individual confidentiality. Data sharing will follow the NIDDK Policy for Data Sharing (https://niddk.nih.gov/research-funding/research-resources/data-management-sharing).
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Adults With Diabetes: Achieving Self-management Success Through Data-Driven Behavior Change, Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06848361
- Acronym / sponsor ID
- MPowerHub / STUDY23080053
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ann-Marie RoslandUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Pittsburgh Foundation
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MPowerHub trial protocol feasibility will be assessed by randomizing 80 adults with type 2 diabetes and glycemic levels above clinical goals to MPowerHub (MPowerHub platform + continuous glucose monitoring \& activity monitoring), continuous glucose monitor alone, or activity monitor alone for four months. Mixed quantitative and qualitative assessments will examine recruitment, engagement, and retention metrics and feedback. Finally, changes in self-management behaviors (measured using semi-structured interview) and clinic glycemic levels (obtained from participants' electronic health record or finger-stick by study research staff) from pre- to post-monitoring will be compared between arms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MPowerHub | Experimental | Device: MPowerHub, Device: Continuous Glucose Monitor (CGM), Device: Activity MonitorParticipants 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. |
| Continuous Glucose Monitor (CGM) Only | Active comparator | Device: Continuous Glucose Monitor (CGM)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. |
| Activity Monitor Only | Active comparator | Device: Activity MonitorParticipants 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPowerHubThe 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. | Device | MPowerHub |
| 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. | Device | Continuous Glucose Monitor (CGM) Only, MPowerHub |
| Activity MonitorA 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. | Device | Activity Monitor Only, MPowerHub |
Primary outcome
Percent of eligible individuals who enroll in the study
Time frame: Pre-baseline
Percent of individuals contacted and found eligible who enroll in the study. The goal benchmark is >/=60%.
Percent of days wearable device data is collected
Time frame: From 0 to 4 months
Percent of days adequate wearable device data is collected during the 4-month intervention. The goal benchmark is >/=75%.
Percent participants retained in study to the 4-month outcome assessment
Time frame: From 0 to 4 months
Percent of participants retained in the study through the 4-month outcome assessment. The goal benchmark is >/=85%.
21 secondary outcomes
Percent of individuals contacted who enroll in the study
Time frame: Pre-baseline
Percent of days self-report data is collected
Time frame: From 0 to 4 months
Percent of weeks participant responds to goal-setting prompts
Time frame: From 0 to 4 months
Participant satisfaction with intervention
Time frame: 4 months
Change in hemoglobin A1c
Time frame: Baseline vs 4-6 Months
Change in diabetes medication regimen
Time frame: From baseline to 4-6 months
Started on insulin
Time frame: From baseline to 4-6 months
Change in medication adherence
Time frame: Baseline vs. 4 Months
Change in healthy eating
Time frame: Baseline vs 4 Months
Change in fruit and vegetable intake per day
Time frame: Baseline vs 4 months
Change in physical activity
Time frame: Baseline vs 4 Months
Change in goal setting
Time frame: Baseline vs 4 months
Change in intrinsic motivation
Time frame: Baseline vs 4 months
Change in extrinsic motivation
Time frame: Baseline vs 4 months
Change in empowerment
Time frame: Baseline vs 4 months
Change in diabetes distress - overall
Time frame: Baseline vs 4 months
Change in diabetes distress - emotional burden
Time frame: Baseline vs 4 months
Change in diabetes distress - regimen distress
Time frame: Baseline vs 4 months
Participant rating of intervention usability
Time frame: 4 months
Participant perceptions of the benefit of continuous glucose monitoring systems
Time frame: 4 months
Participant perceptions of the barriers of continuous glucose monitoring systems
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. Data derived from the trial will be eligible to be shared. Data sets will include only "limited access data" (i.e., no records with personal identifiers). Data sets will be de-identified prior to distribution, and wearable sensor data will be aggregated at a level that is determined to preserve individual confidentiality. Data sharing will follow the NIDDK Policy for Data Sharing (https://niddk.nih.gov/research-funding/research-resources/data-management-sharing).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Marie Rosland, MD, MS principal investigator
University of Pittsburgh
Carissa Low, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPowerHub, Continuous Glucose Monitor (CGM) and Activity Monitor in people with Type 2 Diabetes Mellitus (T2DM), run by Ann-Marie Rosland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of eligible individuals who enroll in the study (time frame: Pre-baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.