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

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

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.

Is the wearable device for Type 2 Diabetes, also known as MPowerHub, safe for humans?

The safety of wearable devices for diabetes management, like insulin pumps, can be affected by device malfunctions or user errors, which may lead to serious issues like high or low blood sugar. However, specific safety data for MPowerHub is not available, and more research is needed to ensure long-term safety in real-world use. ^{1 2 3 4 5}

How is the treatment MPowerHub for type 2 diabetes different from other treatments?

MPowerHub is unique because it integrates wearable devices to provide real-time data for personalized diabetes management, potentially improving self-management and glycemic control by using technology to deliver targeted feedback and educational interventions. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment MPowerHub for Type 2 Diabetes?

Research shows that digital tools and wearable devices can help people with diabetes manage their condition better. For example, the Diabesdagboga app and Diani web portal improved blood sugar control in a patient with Type 1 diabetes, and the MyDiabetesMyWay platform in Scotland has positively impacted self-management for diabetes patients. ^{8 11 12 13 14}

Who Is on the Research Team?

Carissa Low, PhD

Principal Investigator

University of Pittsburgh

Ann-Marie Rosland, MD, MS

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

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]

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]

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]

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]

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]

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 #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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The New Zealand Diabetes Passport Study: a randomized controlled trial of the impact of a diabetes passport on risk factors for diabetes-related complications. [2022]

2. Czech Republic pubmed.ncbi.nlm.nih.gov

Long term use of the telemonitoring system Diani in the therapy of a patient with type 1 diabetes. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus. [2023]

4. United States 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

MyDiabetesMyWay: An Evolving National Data Driven Diabetes Self-Management Platform. [2023]

6. United States 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. [2022]

7. Germany 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. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

First Real-World Experience With Bigfoot Unity: A 6-Month Retrospective Analysis. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The Do-It-Yourself Artificial Pancreas: A Comprehensive Review. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

EMPOWERing Patients With Diabetes Using Profiling and Targeted Feedbacks Delivered Through Smartphone App and Wearable (EMPOWER): Protocol for a Randomized Controlled Trial on Effectiveness and Implementation. [2022]

12. England 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. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Test-retest reliability of a continuous glucose monitoring system in individuals with type 2 diabetes. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Mobile Health and Preventive Medicine. [2023]