Mobile Health Apps for Type 2 Diabetes

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Must not be taking: Antipsychotics, Antidepressants, Steroids

Disqualifiers: Does not check blood glucose

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

45 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your diabetes medications like insulin, thiazolidinediones, or sulfonylureas. However, if you are on medications that promote weight gain, such as certain antipsychotics, antidepressants, or steroid hormones, you may not be eligible to participate.

What data supports the effectiveness of the treatment Mobile health application for Type 2 Diabetes?

Research suggests that mobile health apps can help people with Type 2 Diabetes improve their self-management behaviors, which may lead to better control of blood sugar levels and weight loss. However, the effectiveness can vary, and more studies are needed to understand how these apps can best support patients. ^{1 2 3 4 5}

Are mobile health apps generally safe for humans?

Mobile health apps have shown potential benefits, but there are safety concerns such as poor privacy practices and inaccurate health recommendations. Ensuring patient safety may require better regulation and transparency in app development. ^{6 7 8 9 10}

How do mobile health apps differ from other treatments for type 2 diabetes?

Mobile health apps for type 2 diabetes are unique because they offer a digital, self-management tool that patients can use on their phones to help control their condition. Unlike traditional treatments that may involve medication or in-person consultations, these apps provide a convenient way for patients to track their health and make lifestyle changes on their own. ^{1 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and the subsequent benefit of improving type II diabetes outcomes in a low socioeconomic Hispanic population. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.

Eligibility Criteria

This trial is for Hispanic individuals aged 18-64 with type II diabetes, a BMI of 27 or higher, and an annual income under $47,520. Participants must regularly monitor their blood glucose levels, have access to a weight scale and own a smartphone they can use to download health apps.

Inclusion Criteria

Hispanic and/or Latinx origin

I have been diagnosed with type II diabetes.

BMI ≥ 27

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use mobile health applications to monitor weight and blood glucose levels daily for 6 months

6 months

Daily self-monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mobile health application

Trial Overview The study tests if using mobile health applications can improve the health outcomes of low-income Hispanics with type II diabetes. Over six months, participants will weigh themselves daily and check blood sugar before and after meals.

Participant Groups

Group I: Weight Watchers (WW) Experimental Treatment 1 Intervention

Group II: Healthi app Experimental Treatment 1 Intervention

Group III: Control Active Control 1 Intervention

Mobile health application is already approved in United States, European Union for the following indications:

Approved in United States as mHealth Apps for:

• Type II Diabetes Management
• Health Monitoring

Approved in European Union as mHealth Apps for:

• Type II Diabetes Management
• Health Monitoring
• Chronic Disease Management

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Findings from Research

The ongoing Qatar Diabetes Mobile Application Trial (QDMAT) is evaluating a new mobile app designed for adults with type 2 diabetes (T2DM) treated with insulin, with 180 participants randomized to use the app or receive standard care over 6 months.

The primary goal is to assess the app's effectiveness in improving glycaemic control, measured by changes in HbA1c levels, while also examining its impact on patient empowerment, self-management, and healthcare interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qatar Diabetes Mobile Application Trial (QDMAT): an open-label randomised controlled trial to examine the impact of using a mobile application to improve diabetes care in type 2 diabetes mellitus-a study protocol. Suleiman, N., Alkasem, M., Al Amer, Z., et al.[2022]

The study involving 71 patients with uncontrolled type 2 diabetes revealed that engagement with the mHealth tool i-Matter was driven by both internal factors, like personal accountability, and external factors, such as reminders for self-management behaviors.

Using i-Matter positively influenced patients' attitudes towards their diabetes and health, leading to increased commitment to self-management, although some technical limitations of the tool were identified that could be improved for better user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opening the Black Box of an mHealth Patient-Reported Outcome Tool for Diabetes Self-Management: Interview Study Among Patients With Type 2 Diabetes. Marini, C., Cruz, J., Payano, L., et al.[2023]

In a study of 171 adults with diabetes and prediabetes, high engagement with the Nutritionist Buddy Diabetes app (≥5 features) was linked to a significant weight loss of 10.6% over 6 months, highlighting the app's potential for effective weight management.

Participants who adhered to dietary guidelines, such as maintaining carbohydrate limits and logging meals, experienced notable reductions in HbA1c levels, with those logging meals for more than 5 days achieving a 1.2% reduction, indicating improved glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Mobile Health App Engagement and Weight Loss and Glycemic Control in Adults With Type 2 Diabetes and Prediabetes (D'LITE Study): Prospective Cohort Study. Lim, SL., Tay, MHJ., Ong, KW., et al.[2022]

A systematic review of 453 health apps for chronic conditions found that the average quality score was 3.48 out of 5, indicating that while the apps are of acceptable quality, there is room for improvement.

The potential for these apps to promote behavior change was moderate, with an average score of 8.07 out of 21, suggesting that features like self-monitoring and stress management are common but may not be fully effective in encouraging lasting lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Quality of Health Apps and Their Potential to Promote Behavior Change in Patients With a Chronic Condition or Multimorbidity: Systematic Search in App Store and Google Play. Bricca, A., Pellegrini, A., Zangger, G., et al.[2022]

Mobile health care applications, like the Healthy-note app, can enhance adherence to self-management activities in diabetes patients, showing promise in improving diabetes management.

However, the effectiveness of these mobile apps may vary among patients, indicating a need for further research to boost patient engagement and optimize the use of mobile interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Management via a Mobile Application: a Case Report. Jo, IY., Yoo, SH., Lee, DY., et al.[2020]

The study presents a new architecture for integrating mobile health applications (mHealth Apps) with electronic health records (EHRs), enabling bi-directional data exchange to improve patient engagement in healthcare management.

Using a case study for congestive heart failure patients, the architecture allows clinicians to prescribe monitoring procedures through EHRs, which are then communicated to mHealth Apps, facilitating real-time patient monitoring and reporting without local data storage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Standards-Based Architecture Proposal for Integrating Patient mHealth Apps to Electronic Health Record Systems. Marceglia, S., Fontelo, P., Rossi, E., et al.[2018]

A survey of 274 patients at a Primary Care Center revealed that 68% use mobile health (mHealth) apps, primarily for physical exercise and nutrition, but many have concerns about the reliability and quality of these apps.

There is a strong interest among both users (89%) and non-users (70%) in receiving guidance from health professionals regarding mHealth apps, highlighting the need for healthcare providers to help patients choose reliable and effective applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of Mobile Health Applications in Primary Care Users]. Dolado Martín, C., Berlanga Fernández, S., Fabrellas Padres, N.[2018]

Many mobile health apps, including insulin dose calculators and asthma management tools, have significant methodological weaknesses, such as poor user input validation and inappropriate recommendations, which can compromise patient safety.

A review of health apps revealed serious privacy and security issues, with 28% lacking a privacy policy and some transmitting personal data, highlighting the need for better regulation and transparency in app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Trust but verify'--five approaches to ensure safe medical apps. Wicks, P., Chiauzzi, E.[2022]

Mobile health (mHealth) apps are categorized by their functions, such as behavior change and self-management, but there is limited clinical guidance on their effective use in patient care, highlighting a gap in evidence-based recommendations.

Data security and patient privacy are major concerns when using mHealth apps, and there is a need for better involvement of patients in the development of guidelines to ensure that these apps meet their needs and improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the clinical value of mHealth for patients? Rowland, SP., Fitzgerald, JE., Holme, T., et al.[2023]

mHealth systems can automatically collect and analyze glucose data, providing real-time decision support for both patients and healthcare professionals, which can lead to timely and personalized treatment decisions.

While mHealth shows promise for diabetes management, rigorous testing and regulatory approval are necessary to ensure safety, effectiveness, and to address privacy, clinical, and economic concerns for widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current status of mHealth for diabetes: will it be the next big thing? Klonoff, DC.[2022]

A review of 32 studies on mobile health applications for diabetes revealed that most evaluations used established usability methods, such as expert assessments or validated questionnaires, to ensure the apps function effectively for users.

Combining different usability evaluation methods, including user feedback through interviews and custom questionnaires, can enhance the quality of evidence in assessing these applications, highlighting the importance of rigorous evaluation in mobile health technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Usability Methods Used in the Evaluation of Mobile Health Applications for Diabetes. Georgsson, M.[2020]

The Few Touch application, developed for people with type 2 diabetes, effectively integrates a blood glucose meter, step counter, and food tracking software, demonstrating good usability and motivating users to adjust their medication and lifestyle habits over a 6-month period.

User feedback indicated that the blood glucose sensor was the most valued feature, highlighting the importance of real-time health monitoring in encouraging self-management and lifestyle changes in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone-based self-management tools for type 2 diabetes: the few touch application. Arsand, E., Tatara, N., Østengen, G., et al.[2021]

Mobile health apps can effectively support diabetes control and self-management in patients with type 2 diabetes mellitus (T2DM), as shown by a study involving 25 participants who tested various apps and provided feedback on their experiences.

Despite the potential benefits, participants found the initial effort to learn how to use the apps to be higher than expected, highlighting the need for better integration of these tools into routine care and support from healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Apps for the Control and Self-management of Type 2 Diabetes Mellitus: Qualitative Study on Users' Acceptability and Acceptance. Bults, M., van Leersum, CM., Olthuis, TJJ., et al.[2023]

The Lilly Connected Care Program (LCCP) significantly improved glycemic control in patients with type 2 diabetes mellitus (T2DM) in China, showing a greater reduction in HbA1c levels compared to a non-LCCP group (2.21% vs 1.65%) over a 4-month period.

Participation in the LCCP was associated with a higher likelihood of achieving meaningful HbA1c reductions, with 69% of participants reducing their HbA1c by ≥1%, compared to 57.4% in the non-LCCP group, indicating its effectiveness as a mobile health management tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the Lilly Connected Care Program in Improving Glycemic Management Among Patients With Type 2 Diabetes in China: Retrospective Real-world Study. Su, B., Chen, Y., Shen, X., et al.[2023]

References

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

Qatar Diabetes Mobile Application Trial (QDMAT): an open-label randomised controlled trial to examine the impact of using a mobile application to improve diabetes care in type 2 diabetes mellitus-a study protocol. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Opening the Black Box of an mHealth Patient-Reported Outcome Tool for Diabetes Self-Management: Interview Study Among Patients With Type 2 Diabetes. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Association Between Mobile Health App Engagement and Weight Loss and Glycemic Control in Adults With Type 2 Diabetes and Prediabetes (D'LITE Study): Prospective Cohort Study. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

The Quality of Health Apps and Their Potential to Promote Behavior Change in Patients With a Chronic Condition or Multimorbidity: Systematic Search in App Store and Google Play. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Diabetes Management via a Mobile Application: a Case Report. [2020]

6. Germany pubmed.ncbi.nlm.nih.gov

A Standards-Based Architecture Proposal for Integrating Patient mHealth Apps to Electronic Health Record Systems. [2018]

7. Spain pubmed.ncbi.nlm.nih.gov

[Use of Mobile Health Applications in Primary Care Users]. [2018]

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

'Trust but verify'--five approaches to ensure safe medical apps. [2022]

9. England pubmed.ncbi.nlm.nih.gov

What is the clinical value of mHealth for patients? [2023]

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

The current status of mHealth for diabetes: will it be the next big thing? [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A Review of Usability Methods Used in the Evaluation of Mobile Health Applications for Diabetes. [2020]

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

Mobile phone-based self-management tools for type 2 diabetes: the few touch application. [2021]

13. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Apps for the Control and Self-management of Type 2 Diabetes Mellitus: Qualitative Study on Users' Acceptability and Acceptance. [2023]

14. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of the Lilly Connected Care Program in Improving Glycemic Management Among Patients With Type 2 Diabetes in China: Retrospective Real-world Study. [2023]