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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pilot study is to determine the utility of an algorithm for better glucose control in diabetic patients communicated via an App to help improve outcomes and reduce urgent care and ER visits as well as improve A1C and quality of life.

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 data supports the effectiveness of the treatment Experimental Group instructions for glucose management via App?

Research shows that using mobile phone apps can help people with diabetes better manage their blood sugar levels. Studies found that these apps improve glycemic control, which means they help keep blood sugar levels in a healthier range. ^{1 2 3 4 5}

Is the Diabetes Management App safe for humans?

The safety of diabetes management apps is not well-regulated, and there is limited evidence on their safety and effectiveness. Issues such as app accuracy, data security, and usability have been identified, but no specific safety concerns for humans have been reported. ^{2 6 7 8 9}

How is the Diabetes Management App treatment different from other diabetes treatments?

The Diabetes Management App is unique because it uses a smartphone application to help manage blood sugar levels, offering interactive features and personalized feedback to support self-management, unlike traditional treatments that may not provide real-time guidance or customization. ^{1 2 6 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Do Mobile Phone Applications Improve Glycemic Control (HbA1c) in the Self-management of Diabetes? A Systematic Review, Meta-analysis, and GRADE of 14 Randomized Trials. [2022]

2. England 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. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Usability and clinical efficacy of diabetes mobile applications for adults with type 2 diabetes: A systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effect of mobile phone intervention for diabetes on glycaemic control: a meta-analysis. [2022]

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

Randomized, Controlled Trial of a Digital Behavioral Therapeutic Application to Improve Glycemic Control in Adults With Type 2 Diabetes. [2023]

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

Rapid Evidence Review of Mobile Applications for Self-management of Diabetes. [2019]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group. [2020]

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

Content Analysis: First-Time Patient User Challenges with Top-Rated Commercial Diabetes Apps. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

The development and feasibility of a web-based intervention with diaries and situational feedback via smartphone to support self-management in patients with diabetes type 2. [2018]

11. Denmark pubmed.ncbi.nlm.nih.gov

[Mobile applications for management of Type 2 diabetes]. [2022]