30 Participants Needed

Mobile Health Applications for Type 2 Diabetes

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: San Diego State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

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 type II diabetes outcomes in type 2 diabetics. 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.

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 safety data exists for mobile health apps for diabetes?

The safety data for mobile health apps for diabetes is limited. Many apps have not been rigorously tested, and there are concerns about their methodological weaknesses, such as lack of user input validation and inappropriate recommendations. Privacy and security issues are also prevalent, with some apps lacking privacy policies or transmitting personal data. Regulatory approval will require demonstration of safety and effectiveness, especially for apps making treatment recommendations. More high-quality studies are needed to establish their safety and clinical benefits.12345

Is the treatment Mobile Health Application a promising treatment for Type 2 Diabetes?

Yes, Mobile Health Applications are promising for Type 2 Diabetes because they help patients manage their health better, support lifestyle changes, and improve blood sugar control.678910

What data supports the idea that Mobile Health Applications for Type 2 Diabetes is an effective treatment?

The available research shows that mobile health applications can help people with Type 2 Diabetes manage their condition better. For example, these apps can improve how well patients stick to their self-care routines, which is important for managing diabetes. Some studies mention that these apps have been approved by health authorities like the FDA, indicating their potential effectiveness. However, it's also noted that not all patients may find them helpful, and more research is needed to understand how to make these apps work better for everyone. Compared to other treatments, mobile apps offer the advantage of being easily accessible and can be used to track and encourage healthy behaviors outside of a doctor's office.1112131415

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
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: HealthiExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials
182
Recruited
119,000+

Published Research Related to This Trial

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.
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 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.
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.
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]

Citations

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]
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]
Opening the Black Box of an mHealth Patient-Reported Outcome Tool for Diabetes Self-Management: Interview Study Among Patients With Type 2 Diabetes. [2023]
Diabetes Management via a Mobile Application: a Case Report. [2020]
Health Internet Technology for Chronic Conditions: Review of Diabetes Management Apps. [2021]
The current status of mHealth for diabetes: will it be the next big thing? [2022]
[Use of Mobile Health Applications in Primary Care Users]. [2018]
A Standards-Based Architecture Proposal for Integrating Patient mHealth Apps to Electronic Health Record Systems. [2018]
What is the clinical value of mHealth for patients? [2023]
'Trust but verify'--five approaches to ensure safe medical apps. [2022]
Mobile Health Apps for the Control and Self-management of Type 2 Diabetes Mellitus: Qualitative Study on Users' Acceptability and Acceptance. [2023]
Effectiveness of the Lilly Connected Care Program in Improving Glycemic Management Among Patients With Type 2 Diabetes in China: Retrospective Real-world Study. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Mobile phone-based self-management tools for type 2 diabetes: the few touch application. [2021]
A Review of Usability Methods Used in the Evaluation of Mobile Health Applications for Diabetes. [2020]
Mobile applications for diabetics: a systematic review and expert-based usability evaluation considering the special requirements of diabetes patients age 50 years or older. [2022]
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