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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of mobile health apps in improving health for people with type 2 diabetes, particularly in a low-income Hispanic community. Participants will use a mobile health application to track their weight and blood sugar levels over six months. The study will compare results from two different apps and a control group without an app. Suitable candidates have type 2 diabetes, monitor their blood sugar daily, are Hispanic or Latinx, have a BMI over 27, earn less than $47,520 a year, and own a smartphone. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance diabetes management in the community.

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 prior data suggests that these mobile health applications are safe for use in managing type 2 diabetes?

Research has shown that mobile health apps, like the Healthi app, might help people manage diabetes better by improving blood sugar tracking. However, limited evidence exists regarding the safety and effectiveness of these apps specifically for diabetes. Some concerns include untested apps potentially providing inaccurate results, causing stress or leading to extra doctor visits.

Weight Watchers (WW) offers a plan for people with diabetes to track blood sugar, food, and activities. This app aims to assist with weight loss and lower A1c levels, which reflect the average blood sugar level over 2-3 months, potentially reducing diabetes-related complications. The WW app integrates with trusted blood sugar monitoring systems, suggesting it is safe and reliable.

In summary, while both apps aim to help manage diabetes, the WW app is more supported by established systems. However, safety information for both apps in managing diabetes is still developing, so participants should stay informed and consult their healthcare providers as needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using mobile health apps for managing Type 2 diabetes because they offer a novel approach to treatment. Unlike traditional methods like medication and in-person consultations, these apps provide real-time, personalized feedback and support. The Healthi app and Weight Watchers (WW) app both aim to empower users to manage their condition more effectively through tracking and lifestyle modifications. This tech-savvy approach can potentially increase patient engagement and adherence, leading to better health outcomes.

What evidence suggests that mobile health applications could be effective for type 2 diabetes?

Research shows that mobile health apps can help manage type 2 diabetes by improving blood sugar control. One study found that these apps significantly lowered HbA1c levels, an important measure of blood sugar control. Another study suggests that using mobile apps for diabetes management aids in better glucose monitoring and self-care.

In this trial, participants will use either the Healthi app or the Weight Watchers app. Studies indicate that the Weight Watchers app helps people with diabetes lose weight and lower their HbA1c levels. One report noted that users of the Weight Watchers Diabetes Program achieved better weight loss and health outcomes. Overall, both apps appear promising for managing diabetes by helping track and control blood sugar levels. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12214694/

Evaluating Effectiveness of mHealth Apps for Older Adults ...

The meta-analysis revealed a significant reduction in HbA1c levels (Hedges g –0.40, 95% CI –0.75 to –0.06) among older adults using mHealth apps. Limited data ...

2.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-21056-w

Exploring mHealth app utilization for diabetes self-management

Mobile health applications (mHealth apps) offer potential benefits for improving diabetes management, such as better glucose monitoring and ...

3.

diabetes.jmir.org

diabetes.jmir.org/2023/1/e41076/

Mobile Health Apps for the Control and Self-management of ...

Conclusions: The research showed that mobile health apps provide support for diabetes control and self-management in patients with T2DM.

4.

ajpmonline.org

ajpmonline.org/article/S0749-3797(24)00021-7/fulltext

Smartphone Applications to Prevent Type 2 Diabetes

The aim of this systematic review was to determine the acceptability and effectiveness of smartphone applications (apps) for the prevention of type 2 diabetes.

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1751991821001212

Effectiveness of mobile applications in diabetic patients ...

Managing the lifestyle of patients with diabetes using mobile applications improves short-term glycemic control, but the long-term results are not conclusive.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11660773/

Exploring mHealth app utilization for diabetes self-management

Mobile health applications (mHealth apps) offer potential benefits for improving diabetes management, such as better glucose monitoring and ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5541938/

Evidence-based Mobile Medical Applications in Diabetes - PMC

Mobile medical apps have been shown to positively affect outcomes, including A1C level. More long-term studies are needed to identify best practices.

8.

diabetesjournals.org

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

Diabetes Digital App Technology: Benefits, Challenges, and ...

The available evidence on the safety and effectiveness of mobile health apps, especially for diabetes, remains limited. The European Association for the ...

9.

researchprotocols.org

researchprotocols.org/2024/1/e48781/

Compliance of Type 2 Diabetes Applications to ...

The aims of this study are to develop the Analysis of Diabetes Apps (ADA) checklist to evaluate apps' compliance to guidelines set by the International ...

10.

academic.oup.com

academic.oup.com/jamia/article/27/2/330/5585394

Safety concerns with consumer-facing mobile health ...

A review of apps for type 2 diabetes risk assessment reported that false positives generated by unvalidated risk scores could overwhelm services ...