Mobile Health Applications 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 glucose, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mobile health app can help people with type 2 diabetes manage their condition more effectively. Participants will use the app to track their weight and blood sugar levels daily for six months. The goal is to determine if the app improves health outcomes for those with type 2 diabetes. This trial suits individuals who have had type 2 diabetes for at least three months, check their blood sugar daily, and are comfortable using a smartphone app. As an unphased trial, this study provides an opportunity to explore innovative ways to manage diabetes effectively.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on medications that promote weight gain, like antipsychotics, antidepressants, or steroid hormones. Diabetes medications like insulin, thiazolidinediones, or sulfonylureas are okay.

What prior data suggests that mobile health applications are safe for type 2 diabetes management?

Research shows that mobile health apps can help people manage diabetes by supporting better control of blood sugar levels. Studies have found that users of these apps often achieve improved blood sugar readings, such as lower HbA1c levels, which measure long-term blood sugar control. Although major safety issues have not been reported, evidence on safety remains limited, and further research is needed. Overall, mobile health apps are generally considered safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile health application, Healthi, for managing Type 2 Diabetes because it offers a unique approach compared to traditional methods like medication, insulin therapy, and lifestyle changes. Unlike standard treatments that often require frequent doctor visits and strict regimens, Healthi leverages digital technology to provide personalized, real-time support and feedback directly to users' smartphones. This approach not only enhances patient engagement and convenience but also empowers individuals to manage their condition more effectively on a daily basis. By integrating technology with health management, Healthi has the potential to revolutionize how patients interact with their diabetes care.

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

Research has shown that mobile health apps can help people with type 2 diabetes improve their health. In this trial, participants will either use the "Healthi" mobile health app or join a control group with no intervention. Studies have found that these apps can lower HbA1c levels, an important measure of blood sugar control. Specifically, one study found that apps designed for managing diabetes helped reduce these levels in patients. Another study showed that these apps improve diabetes management, which is crucial for maintaining health. Additionally, mobile health tools have improved blood sugar levels in various groups, including African American and Latinx communities. Overall, this evidence suggests that using a mobile health app can be an effective way to manage type 2 diabetes. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 with type 2 diabetes who regularly monitor their blood glucose, have a BMI of 25 or higher, and own a smartphone. They must be willing to use a mobile health app daily and have been diagnosed with diabetes for at least three months. People using certain weight gain-promoting medications cannot join.

Inclusion Criteria

BMI ≥ 25

Monitors blood glucose regularly (at least once per day)

Owns or has access to a bathroom weight scale

Exclusion Criteria

Does not check blood glucose at least once per day

I am taking medications that can cause weight gain, like antipsychotics or steroids.

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

6 months

Daily self-monitoring

Follow-up

Participants are monitored for long-term changes in diabetes management and quality of life

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 people with type 2 diabetes over six months. Participants will weigh themselves and check their blood sugar levels before and after meals every day using the app.

How Is the Trial Designed?

Group I: Healthi Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

A review of 12 popular mHealth apps for diabetes management revealed that while all apps included blood glucose tracking, they varied significantly in other key features, highlighting the inconsistency in app quality and functionality.

The study emphasizes the need for regulation and standardization in the development of mHealth apps to ensure effective chronic disease management, as current consumer preferences are based on popularity rather than clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Internet Technology for Chronic Conditions: Review of Diabetes Management Apps. Sneha, S., Thalla, S., Rischie, I., et al.[2021]

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]

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 656 diabetes apps revealed that most (54.1%) offer only one function, with a majority being free (53.7%) and an average user rating of 3.6 stars, indicating a need for more diverse and higher-quality app functionalities.

Usability evaluations showed that while apps were generally comprehensible (average rating of 4.0), those with multiple functions had significantly lower usability scores, particularly when including documentation or analysis features, suggesting that simpler apps may better serve older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications for diabetics: a systematic review and expert-based usability evaluation considering the special requirements of diabetes patients age 50 years or older. Arnhold, M., Quade, M., Kirch, W.[2022]

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]

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]

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