Wearable Devices for Type 2 Diabetes

(MPowerHub Trial)

Overseen By Ann-Marie Rosland, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ann-Marie Rosland

Must be taking: Non-insulin diabetes

Must not be taking: Insulin, CGM devices

Disqualifiers: Type 1 diabetes, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping individuals with type 2 diabetes manage their condition more effectively using wearable devices. It will test three different setups: a full suite of tools called MPowerHub (a comprehensive management system), a continuous glucose monitor (CGM), or an activity tracker. The goal is to determine how these devices assist individuals in adhering to their medication, monitoring glucose levels, and developing healthy habits, ultimately enhancing their health and quality of life. It is suitable for those with type 2 diabetes who do not use insulin, have a recent glucose level above 7.5%, and are comfortable using a smartphone app. As an unphased trial, this study provides a unique opportunity to explore innovative diabetes management tools and contribute to advancing healthcare solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you are currently prescribed at least one non-insulin diabetes medication.

What prior data suggests that these wearable devices are safe for managing type 2 diabetes?

Research has shown that wearable devices for managing diabetes, such as MPowerHub, are generally safe. Problems like device malfunctions or user mistakes occur rarely. Previous studies focused on improving the MPowerHub app for people with type 2 diabetes did not find any major safety issues. Continuous glucose monitors (CGM) and activity trackers, also part of this trial, have been widely used and are known to be well-tolerated. Overall, evidence suggests these devices are safe to use, with only minor risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MPowerHub because it offers a comprehensive, tech-driven approach to managing Type 2 diabetes. Unlike traditional methods that might rely on medication or periodic glucose monitoring, MPowerHub integrates real-time data from a continuous glucose monitor and an activity tracker. This allows for personalized feedback and adjustments in diabetes management, fostering proactive health decisions. By empowering individuals with immediate insights and tailored coaching, MPowerHub aims to enhance adherence to lifestyle changes and potentially improve long-term health outcomes.

What evidence suggests that this trial's wearable devices could be effective for managing type 2 diabetes?

Research shows that digital tools like MPowerHub, which participants in this trial may use, can help people manage type 2 diabetes more effectively. Studies on similar tools, such as DM4All and DiaWatch, have demonstrated improvements in blood sugar control. This trial will test MPowerHub alongside other devices. Participants in different arms will use either MPowerHub with wearable devices, a continuous glucose monitor (CGM) only, or an activity tracker only. Continuous glucose monitors (CGMs) provide real-time blood sugar information, aiding in diabetes management. Activity trackers encourage physical activity, which is crucial for controlling diabetes. Together, these tools aim to simplify and enhance diabetes management. ^{1 2 6 7 8}

Who Is on the Research Team?

Ann-Marie Rosland, MD, MS

Principal Investigator

University of Pittsburgh

Carissa Low, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who need help managing their condition. Participants should be interested in using wearable devices like glucose and activity monitors to track their health data.

Inclusion Criteria

I have been diagnosed with type 2 diabetes.

I can use a basic smartphone app.

Last Hemoglobin A1c (HbA1c) value obtained in the last 6 months was ≥7.5%

Exclusion Criteria

I have been diagnosed with diabetes during pregnancy only.

I have been diagnosed with type 1 diabetes.

I was diagnosed with type 2 diabetes before I turned 21.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use assigned study devices (MPowerHub, CGM, and/or activity tracker) for 4 months

16 weeks

Initial in-person visit for device training and education

Follow-up

Participants are monitored for changes in self-management behaviors and clinical outcomes

4-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MPowerHub

Trial Overview The study tests the MPowerHub system, which helps participants use data from wearables like Continuous Glucose Monitors (CGM) and Activity Monitors to manage diabetes more effectively.

How Is the Trial Designed?

Group I: MPowerHub Experimental Treatment 3 Interventions

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.

Group II: Continuous Glucose Monitor (CGM) Only Active Control 1 Intervention

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.

Group III: Activity Monitor Only Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ann-Marie Rosland

Lead Sponsor

Trials

1

Recruited

80+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

The Pittsburgh Foundation

Collaborator

Trials

8

Recruited

470+

Published Research Related to This Trial

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but users face significant risks from potential errors in insulin delivery, which can lead to serious health issues like hyperglycemia or hypoglycemia.

Current safety evaluations of insulin pumps are inadequate, with limited transparency in reporting adverse events and insufficient long-term data on real-world usage, highlighting the need for improved regulatory practices and more comprehensive research on pump therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2018]

The Diabesdagboga smartphone app and Diani web portal allow for comprehensive tracking of diabetes-related data, including blood sugar levels, carbohydrate intake, insulin doses, and physical activity, enhancing patient engagement and data analysis.

A case report of a patient using this system for nearly two years showed a significant improvement in metabolic control, with an 18.6 mmol/mol decrease in HbA1c, indicating better long-term blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term use of the telemonitoring system Diani in the therapy of a patient with type 1 diabetes. Brož, J., Holubová, A., Mužík, J., et al.[2022]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

The #WeAreNotWaiting movement has led to the development of do-it-yourself artificial pancreas systems (DIYAPS) by motivated individuals in the diabetes community, which integrate continuous glucose monitoring and insulin pumps to improve glycemic control and quality of life for people with type 1 diabetes.

While DIYAPS show promising improvements in diabetes management based on anecdotal evidence and observational studies, their unregulated nature raises safety concerns, and there are significant barriers to acceptance among healthcare professionals and regulatory bodies due to ethical, legal, and funding issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Do-It-Yourself Artificial Pancreas: A Comprehensive Review. Kesavadev, J., Srinivasan, S., Saboo, B., et al.[2021]

Wearable health devices, like activity trackers and mobile ECGs, have proven effective in various prevention strategies, helping to promote fitness, detect heart issues, and manage diabetes.

The future of mHealth looks promising with advancements in integrating diverse data and using AI-driven health coaches, which could enhance both individual health management and overall public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health and Preventive Medicine. Waalen, J.[2023]

A study involving 549 participants from the TuDiabetes.org online community found that 75 reported device-related adverse events, with nearly half requiring intervention, highlighting the potential for online networks to capture real-world device issues.

Only 4% of these adverse events were reported to the FDA, suggesting that online participatory surveillance can provide more comprehensive outcome data compared to traditional reporting methods, which often lack detailed information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. Mandl, KD., McNabb, M., Marks, N., et al.[2021]

The use of digital self-management solutions for Type 2 diabetes, such as DM4All and DiaWatch, led to significant improvements in metabolic outcomes, including reductions in HbA1c, body weight, blood pressure, and cholesterol levels over an average follow-up of 8 months in 100 patients.

Compared to a control group, the ProEmpower participants showed significantly better improvements in cardiovascular risk factors, highlighting the efficacy of digital technologies in enhancing diabetes management and promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus. De Luca, V., Bozzetto, L., Giglio, C., et al.[2023]

The continuous glucose monitoring system (CGMS) demonstrated high test-retest reliability in measuring glucose levels in individuals with type 2 diabetes, with relative reliability scores ranging from 0.77 to 0.95 for various glycemic measures.

Specific measures of glycemic variability, such as standard deviation (SD(w)) and mean amplitude of glycemic excursions (MAGE), showed significant reliability, indicating that CGMS can be effectively used in clinical trials for monitoring glucose levels over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test-retest reliability of a continuous glucose monitoring system in individuals with type 2 diabetes. Terada, T., Loehr, S., Guigard, E., et al.[2022]

In a study involving 27 participants with type 1 diabetes, an automated insulin delivery (AID) system that used real-time exercise data (exMPC) showed a significant reduction in mean glucose levels during exercise compared to a standard AID system (exAPD), indicating improved glucose management during physical activity.

Both AID systems effectively reduced the time spent in hypoglycemia and maintained glucose levels within the target range, demonstrating that integrating wearable fitness data into insulin dosing can enhance safety and efficacy for individuals with type 1 diabetes during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating metabolic expenditure information from wearable fitness sensors into an AI-augmented automated insulin delivery system: a randomised clinical trial. Jacobs, PG., Resalat, N., Hilts, W., et al.[2023]

In a 6-month study involving 100 adults with type 1 diabetes, the use of the iBGStar® glucose meter combined with an iPhone led to a significant reduction in A1c levels compared to traditional self-monitoring methods (-0.51 vs. -0.16, p = 0.04).

Both groups showed improvements in hypoglycemia fear scores, but the iBGStar® group did not experience an increased risk of hypoglycemia, indicating that this mobile technology can enhance glycemic control without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management. Garg, SK., Shah, VN., Akturk, HK., et al.[2020]

Citations

1. reporter.nih.gov reporter.nih.gov/search/EaC3BhVN6USBfOMuTswDVQ/project-details/11061089

Project Details The goal of this project is to optimize the MPower Hub intervention protocol for adults with type 2 diabetes in preparation for a future multi-site efficacy ...

2. withpower.com withpower.com/trial/phase-diabetes-mellitus-3-2025-33268

Wearable Devices for Type 2 Diabetes (MPowerHub Trial) The use of digital self-management solutions for Type 2 diabetes, such as DM4All and DiaWatch, led to significant improvements in metabolic outcomes, including ...

3. clinconnect.io clinconnect.io/trials/NCT06848361

Helping Adults With Type 2 Diabetes Use Their Health - ClinConnect The MPowerHub trial is a research study designed to help adults with type 2 diabetes manage their health better by using information from wearable devices ...

4. complexcaring.pitt.edu complexcaring.pitt.edu/research-overview/studies

Core Projects In 2024, we conducted a study to optimize the MPowerHub app and intervention protocol for adults with type 2 diabetes. This year, we have ...

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07097415

Continuous blood glucose monitoring assisted blood glucose ... This study investigates the effectiveness and implementation of continuous glucose monitoring (CGM) technology for type 2 diabetes management in Chinese ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39951268/

Automated Insulin Delivery in Adults With Type 2 Diabetes In this nonrandomized clinical trial, HbA1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation.

7. complexcaring.pitt.edu complexcaring.pitt.edu/

Home | Caring for Complex Chronic Conditions Research ... Our work addresses care for diabetes, heart disease, and other similar and multiple chronic conditions, through innovations in healthcare delivery.

8. ichgcp.net ichgcp.net/clinical-trials-registry/research/list?page=297&spons=Vitamix%2BFoundation

Search results for Vitamix Foundation - Clinical Trials Registry Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management (MPowerHub). Type 2 Diabetes Mellitus (T2DM).