Diabetes Management App for Diabetes

(GEMApp Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marshall University

Disqualifiers: Pregnancy, Cognitive impairment

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app designed to help people with diabetes manage their blood sugar levels more effectively. The goal is to determine if the app can improve health outcomes, reduce emergency visits, and enhance quality of life. Participants will either use a fully functional app with a special algorithm for glucose management or a basic version without it. Individuals with type 1 or type 2 diabetes who are under treatment, own a smartphone, and have at least a sixth-grade education may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatment since the study involves using an app to help manage diabetes.

What prior data suggests that this app is safe for diabetes management?

Research has shown that diabetes management apps can help lower HbA1c levels, a measure of long-term blood sugar control. This indicates their usefulness in managing diabetes. A review of several diabetes apps found many to be "safe and secure" for managing the condition. Some healthcare providers have observed that patients adhere better to their treatment plans and improve blood sugar control when using these apps. Although more high-quality research is needed, current evidence suggests that using an app for diabetes management is generally safe and well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this diabetes management app because it uses an advanced algorithm to provide personalized glucose management instructions via a smartphone. Unlike traditional diabetes treatments that primarily involve medication and routine doctor visits, this app allows for real-time data analysis and feedback, making it more convenient for users to manage their condition on the go. The functioning app offers a user-friendly interface that adapts to individual needs, potentially increasing adherence to diabetes management plans and improving overall outcomes. This innovative approach could transform how people with diabetes monitor and manage their blood sugar levels, offering a more tailored and efficient solution.

What evidence suggests that this app is effective for diabetes management?

Research has shown that diabetes management apps can help control blood sugar levels. In this trial, participants will divide into two groups: one will use a functioning app with a complete algorithm for glucose management, while the other will use a non-functioning app that provides routine instructions. One study found that using a smartphone app significantly lowered blood sugar and reduced HbA1c by 10.63%. Another study showed that digital tools for managing diabetes improved both blood sugar levels and body weight in people with type 2 diabetes. Users of these apps also lost weight and maintained more consistent blood sugar levels within a healthy range. Overall, these findings suggest that diabetes apps can effectively manage the condition. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with type 1 or type 2 diabetes who are under treatment by the Marshall Internal Medicine Department. Participants must have a smartphone and at least a sixth-grade education level. Pregnant women and those with cognitive impairments cannot join.

Inclusion Criteria

I am being treated for diabetes with medication, not just diet or exercise.

Treatment by Marshall Internal Medicine Department

At least 6th grade education level

Exclusion Criteria

You are pregnant.

I have difficulty with memory or thinking clearly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the GEM app to manage glycemic emergencies and improve glucose control

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Experimental Group instructions for glucose management via App
• Placebo Comparator general instructions

Trial Overview The study tests an app that gives instructions for managing blood sugar levels to see if it can improve diabetic care, reduce emergency room visits, better A1C levels (a measure of blood sugar control), and enhance quality of life compared to general advice.

How Is the Trial Designed?

Group I: Functioning App Experimental Treatment 1 Intervention

These subjects have the complete algorithm functioning and communicated via the App.

Group II: Non-functioning App Placebo Group 1 Intervention

These subjects receive routine instructions via the App but not the complete algorithm.

Who Is Running the Clinical Trial?

Marshall University

Lead Sponsor

Trials

21

Recruited

3,900+

Published Research Related to This Trial

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]

Using the Diahome smartphone app for diabetes management led to a significant reduction in fasting blood glucose levels among users, from 156 mg/dl to 129 mg/dl, compared to conventional treatment.

App users also showed a greater percentage improvement in HbA1c levels (15.8%) compared to non-app users (10.4%), indicating that the app may enhance glycaemic control in patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in glycaemic control in patients with type 2 diabetes with treatment using an interactive mobile application - A pilot study from India. Raghavan, A., Nanditha, A., Satheesh, K., et al.[2022]

A systematic review of diabetes mobile applications found that while usability ratings from users and experts ranged from 38% to 80%, significant usability issues such as complex navigation and limited functionality were common.

Despite these usability challenges, diabetes apps showed some clinical effectiveness, with reductions in HbA1c levels between 0.15% and 1.9%, indicating potential for improving glycemic control in adults with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. Fu, H., McMahon, SK., Gross, CR., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39489882/

Mobile apps for diabetes self-management: An updated ... Although higher-quality research is needed, current reviews suggest that many diabetes apps are effective in lowering HbA1c.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11914849/

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

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751991825000427

Diabetes self-management smartphone application Using smartphone app yielded a significant reduction in mean BG level (-17.64 %, p = 0.012) that decreased HbA1c ( −10.63 %, p = 0.000). Increase of SMBG ...

4. nature.com nature.com/articles/s41746-025-01430-7

Impact of digital health interventions on glycemic control ... Higher app engagement correlated with greater TIR improvements. Users also experienced an average weight reduction of 3.3 lbs over 33 days.

5. link.springer.com link.springer.com/article/10.1007/s13300-025-01768-x

Evaluating the Impact of mySugr® Mobile Health ... The study concluded that the mySugr® app, when used with the Accu-Chek® Instant glucose meter, effectively improves blood sugar control and is ...

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

Diabetes Digital App Technology: Benefits, Challenges, and ... The NHS has so far listed 13 apps that are “safe and secure” for the management of diabetes: Changing Health, GDm-Health, Liva UK, Low Carb Program, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317943/

Evaluating the Impact of mySugr® Mobile Health ... Providers reported improved adherence, better glucose control, and more effective treatment adjustments based on app-generated data. The ...

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

Understanding Device Integrations Within Diabetes Apps Background: Diabetes management involves a large degree of data collection and self-care in order to accurately administer insulin.

9. mysugr.com mysugr.com/

Welcome to mySugr US - simplifying life with diabetes | mySugr The mySugr app stores all your diabetes data from devices, integrations, and manual entries in one place—simple, smart, and convenient.