Mobile Health Apps for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: San Diego State University
Must not be taking: Antipsychotics, Antidepressants, Steroids
Disqualifiers: Does not check blood glucose
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Are 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.
678910How 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.
111121314Eligibility 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.
I am between 18 and 64 years old.
+5 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Weight Watchers (WW)Experimental Treatment1 Intervention
Group II: Healthi appExperimental Treatment1 Intervention
Group III: ControlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
San Diego State UniversitySan Diego, CA
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Who Is Running the Clinical Trial?
San Diego State UniversityLead Sponsor
References
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]Mobile health (mHealth) is increasingly advocated for diabetes management. It is unclear if mobile applications are effective in improving glycaemic control, clinical outcomes, quality of life and overall patient satisfaction in patients with type 2 diabetes (T2DM). A new mobile application was specifically built for people with T2DM with the help of the local expertise. The objective of the study was to evaluate the effectiveness of the mobile app.
Opening the Black Box of an mHealth Patient-Reported Outcome Tool for Diabetes Self-Management: Interview Study Among Patients With Type 2 Diabetes. [2023]Mobile health (mHealth) tools are used to collect data on patient-reported outcomes (PROs) and facilitate the assessment of patients' self-management behaviors outside the clinic environment. Despite the high availability of mHealth diabetes tools, there is a lack of understanding regarding the underlying reasons why these mHealth PRO tools succeed or fail in terms of changing patients' self-management behaviors.
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]Mobile health apps are increasingly used as early intervention to support behavior change for diabetes prevention and control, with the overarching goal of lowering the overall disease burden.
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]Mobile apps offer an opportunity to improve the lifestyle of patients with chronic conditions or multimorbidity. However, for apps to be recommended in clinical practice, their quality and potential for promoting behavior change must be considered.
Diabetes Management via a Mobile Application: a Case Report. [2020]Recently, mobile health care has been applied to manage diabetes requiring self-management. Health care by mobile applications (apps) has a great advantage when applied to patients with diabetes; the adherence to self-management activities for diabetes can be improved through mobile apps. The Food and Drug Administration (FDA) has cleared and approved the use of some mobile apps as medical devices for the management of diabetes since 2010. However, mobile apps may not be effective for all patients. We here report the effect of use of mobile-based diabetes care app (Healthy-note app) for 2 patients with diabetes, and discuss issues and strategies for effective mobile intervention. Further study is needed on improving patient's participation to increase the effect of management via a mobile app.
A Standards-Based Architecture Proposal for Integrating Patient mHealth Apps to Electronic Health Record Systems. [2018]Mobile health Applications (mHealth Apps) are opening the way to patients' responsible and active involvement with their own healthcare management. However, apart from Apps allowing patient's access to their electronic health records (EHRs), mHealth Apps are currently developed as dedicated "island systems".
[Use of Mobile Health Applications in Primary Care Users]. [2018]There are more than 165,000 mobile applications (apps) related to health (mHealth) available to patients, promoting their empowerment and reducing healthcare costs; but not all are reliable , safe and quality.
'Trust but verify'--five approaches to ensure safe medical apps. [2022]Mobile health apps are health and wellness programs available on mobile devices such as smartphones or tablets. In three systematic assessments published in BMC Medicine, Huckvale and colleagues demonstrate that widely available health apps meant to help patients calculate their appropriate insulin dosage, educate themselves about asthma, or perform other important functions are methodologically weak. Insulin dose calculators lacked user input validation and made inappropriate dose recommendations, with a lack of documentation throughout. Since 2011, asthma apps have become more interactive, but have not improved in quality; peak flow calculators have the same issues as the insulin calculators. A review of the accredited National Health Service Health Apps Library found poor and inconsistent implementation of privacy and security, with 28% of apps lacking a privacy policy and one even transmitting personally identifying data the policy claimed would be anonymous. Ensuring patient safety might require a new approach, whether that be a consumer education program at one extreme or government regulation at the other. App store owners could ensure transparency of algorithms (whiteboxing), data sharing, and data quality. While a proper balance must be struck between innovation and caution, patient safety must be paramount.Please see related articles: http://dx.doi.org/10.1186/s12916-015-0444-y , http://www.biomedcentral.com/1741-7015/13/106 and http://www.biomedcentral.com/1741-7015/13/58.
What is the clinical value of mHealth for patients? [2023]Despite growing interest from both patients and healthcare providers, there is little clinical guidance on how mobile apps should be utilized to add value to patient care. We categorize apps according to their functionality (e.g. preventative behavior change, digital self-management of a specific condition, diagnostic) and discuss evidence for effectiveness from published systematic reviews and meta-analyses and the relevance to patient care. We discuss the limitations of the current literature describing clinical outcomes from mHealth apps, what FDA clearance means now (510(k)/de novo FDA clearance) and in the future. We discuss data security and privacy as a major concern for patients when using mHealth apps. Patients are often not involved in the development of mobile health guidelines, and professionals' views regarding high-quality health apps may not reflect patients' views. We discuss efforts to develop guidelines for the development of safe and effective mHealth apps in the US and elsewhere and the role of independent app reviews sites in identifying mHealth apps for patient care. There are only a small number of clinical scenarios where published evidence suggests that mHealth apps may improve patient outcomes.
The current status of mHealth for diabetes: will it be the next big thing? [2022]mHealth is an emerging concept in health care and uses mobile communications devices for health services and information. Mobile phones, patient monitoring devices, tablets, personal digital assistants, and other wireless devices can be part of mHealth systems. With mHealth systems, glucose data can now be automatically collected, transmitted, aggregated with other physiologic data, analyzed, stored, and presented as actionable information. mHealth systems use mobile decision support software applications (or apps) to assist or direct health care professionals to make decisions, or they can assist or direct patients to make decisions without waiting for input from a clinician. With real-time decision support for patients, appropriate actions can be taken in real time without waiting to see a clinician. Decisions can be personalized if individual treatment goals and personal preferences for treatment are inputted into an app. Few mHealth apps for diabetes have been rigorously tested. Outcome studies of the use of mHealth for diabetes from the literature have shown the potential for benefits, but higher-quality studies are needed. Regulatory approval of mHealth products will require demonstration of safety and effectiveness, especially where information and trends are not just presented to patients, but used to make treatment recommendations. Three additional hurdles must be overcome to facilitate widespread adoption of this technology, including demonstration of the following: (1) privacy to satisfy regulators, (2) clinical benefit to satisfy clinicians, and (3) economic benefit to satisfy payers. mHealth for diabetes is making rapid strides and is expected to be a transforming technology that will be the next big thing.
A Review of Usability Methods Used in the Evaluation of Mobile Health Applications for Diabetes. [2020]Mobile health applications for diabetes are developed like never before and many patients use them for their personalized health needs. With increased use, an increased number of usability evaluations are performed to assure that the applications function as intended. In this review the goal was to determine what usability methods are currently used in the evaluation of mobile health applications for diabetes and how these are used.
Mobile phone-based self-management tools for type 2 diabetes: the few touch application. [2021]Mobile phones and other mobile information and communication technology applications and technologies hold great potential as a basis for powerful patient-operated self-management tools within diabetes. The work presented shows how such tools can be designed for supporting lifestyle changes among people with type 2 diabetes and how these were perceived by a group of 12 patients during a 6-month period.
Mobile Health Apps for the Control and Self-management of Type 2 Diabetes Mellitus: Qualitative Study on Users' Acceptability and Acceptance. [2023]Mobile health apps are promising tools to help patients with type 2 diabetes mellitus (T2DM) improve their health status and thereby achieve diabetes control and self-management. Although there is a wide array of mobile health apps for T2DM available at present, apps are not yet integrated into routine diabetes care. Acceptability and acceptance among patients with T2DM is a major challenge and prerequisite for the successful implementation of apps in diabetes care.
Effectiveness of the Lilly Connected Care Program in Improving Glycemic Management Among Patients With Type 2 Diabetes in China: Retrospective Real-world Study. [2023]Type 2 diabetes mellitus (T2DM) is a worldwide public health concern. Mobile health management platforms could be a potential way to achieve effective glycemic control.