Healthmine App for Type 2 Diabetes

(REFLECT2DPilot Trial)

Overseen By Mary Ellen Vajravelu, MD, MSHP

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Cognitive impairment, Severe psychiatric conditions

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

Compensation: Varies

Number of Visits: 1

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app called the Healthmine app, designed to help manage type 2 diabetes. Participants will use the app alongside a continuous glucose monitor (a device that tracks blood sugar levels) and a Fitbit for 30 days. The goal is to determine how these tools can support healthy habits like staying active and eating well. Suitable candidates are 16-24 years old, speak English, were diagnosed with type 2 diabetes before age 18, and have a smartphone compatible with the FreeStyle Libre app.

As an unphased trial, this study offers a unique opportunity to explore innovative ways to manage diabetes and improve health habits.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a smartphone app and using a glucose monitor, so you may not need to change your medications.

What prior data suggests that the Healthmine app and devices are safe for use in this study?

Research has shown that mobile health apps can be safe and helpful for managing type 2 diabetes. For example, the FDA has approved apps like WellDoc's BlueStar Rx, confirming their safety and effectiveness. Another app, Una for Diabetes, is certified as a Digital Health Application, meeting safety standards.

This trial will test the Healthmine app alongside a continuous glucose monitor (CGM) and a Fitbit device. These tools are commonly used in diabetes care and are generally well-received. No specific reports of safety issues have emerged with similar apps or devices. Participants in these studies often find them helpful and easy to use.

Overall, research supports the safety of using diabetes management apps and related devices like CGMs and Fitbits for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthmine app for Type 2 Diabetes because it offers a unique approach to managing the condition. Unlike traditional treatments that primarily focus on medication and dietary adjustments, this app supports health behavior change by integrating technology with continuous glucose monitoring and physical activity tracking through a Fitbit. This innovative combination allows for real-time feedback and personalized insights, empowering users to make informed lifestyle decisions. Additionally, the app's ability to gather participant experiences via questionnaires and interviews provides valuable data that could enhance future diabetes management strategies.

What evidence suggests that the Healthmine app is effective for type 2 diabetes?

Research shows that mobile health apps designed for diabetes can significantly help people with type 2 diabetes manage their blood sugar levels. These apps have been found to lower HbA1c levels, an important indicator of long-term blood sugar control. Other studies indicate that using these apps can also lead to a lower BMI and weight loss. These tools function effectively at home, providing a convenient and helpful way to manage diabetes daily. Overall, digital apps for diabetes management hold promise in empowering people to take charge of their health. Participants in this trial will pilot-test the Healthmine app, a novel smartphone app supporting health behavior change, while wearing a continuous glucose monitoring device and a Fitbit physical activity tracker for 30 days. ^{6 7 8 9 10}

Who Is on the Research Team?

Mary Ellen Vajravelu, MD, MSHP

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 16-24 who were diagnosed with type 2 diabetes before age 18. They should be willing to use a smartphone app, wear a continuous glucose monitor (CGM) and Fitbit device, and complete surveys about their health behaviors.

Inclusion Criteria

I am between 16 and 24 years old.

I was diagnosed with type 2 diabetes before I turned 18.

Possession of personal smartphone that is compatible with FreeStyle Libre app

Exclusion Criteria

I do not have severe mental health issues that would stop me from managing my diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in pilot-testing a novel smartphone app and wear a continuous glucose monitoring device and Fitbit for 30 days

30 days

1 visit (in-person) at the start, 1 visit (in-person) at the end

Follow-up

Participants are monitored for feedback on the app and devices, including surveys and interviews

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthmine app

Trial Overview The study tests a new smartphone app called Healthmine designed to help manage type 2 diabetes. Participants will use the app alongside wearing a CGM and Fitbit for 30 days to track blood sugar levels, physical activity, and receive health behavior messages.

How Is the Trial Designed?

Group I: Single-arm pilot study Experimental Treatment 1 Intervention

Participants will engage in pilot-testing a novel smartphone app supporting health behavior change and wear a continuous glucose monitoring device and Fitbit physical activity tracker for 30 days. Questionnaires and interviews will be used to gather participant experiences with the app and device wear.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

San Diego State University

Collaborator

Trials

182

Recruited

119,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7920757/

Effectiveness of Disease-Specific mHealth Apps in Patients ... DM-specific mHealth apps improved the glycemic control by significantly reducing HbA 1c values in patients with T1DM and T2DM patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666970625000277

Efficacy of a mobile application for glycemic control in type ... The intervention group showed a significant reduction in BMI (−0.47 kg/m², p = 0.048), and trends toward lower weight (−1.47 kg, p = 0.054) and systolic blood ...

3. jmir.org jmir.org/2025/1/e66441/

Effectiveness of Digital Diabetes Management Technology ... Digital diabetes management has been shown to effectively improve blood glucose levels and BMI in individuals with T2DM in home settings.

4. bmjopen.bmj.com bmjopen.bmj.com/content/12/11/e060108

Effectiveness of self-management applications in ... Our objective is to identify the effectiveness of mHealth applications in managing blood glucose levels of individuals with T2DM

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12182558/

Enhancing Mobile App Adoption for Type 2 Diabetes ... This study aimed to explore strategies to increase the adoption of mobile apps for medication adherence and T2DM self-management.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9947812/

Mobile Health Apps for the Control and Self-management of ... The research showed that mobile health apps provide support for diabetes control and self-management in patients with T2DM.

7. diabetesjournals.org diabetesjournals.org/care/article/43/1/250/35864/Diabetes-Digital-App-Technology-Benefits

Diabetes Digital App Technology: Benefits, Challenges, and ... An example is WellDoc's BlueStar Rx mobile app, which was cleared by the FDA as a prescription-only app to support the management of type 2 diabetes.

8. diabetes.jmir.org diabetes.jmir.org/2025/1/e62926

Understanding Device Integrations Within Diabetes Apps We systematically identified 21 diabetes apps that offer integrations. We conducted a detailed analysis of 602 user reviews.

9. play.google.com play.google.com/store/apps/details?id=io.unahealth.uh_app&hl=en_AU

Una for Diabetes – Apps on Google Play Una for Diabetes is an app for people with Type 2 Diabetes and has been certified as a Digital Health Application (DiGA) since 2024. The app ...

10. nature.com nature.com/articles/s41598-025-24172-8

My diabetes care: an AI-based mobile app with ... This study evaluates the effectiveness of My Diabetes Care, a mobile application featuring an animated conversational agent, Dia-vera, designed ...