Mobile Health Applications 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 glucose, others
No Placebo Group
Approved in 1 Jurisdiction
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 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 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.
12345What 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.
678910Eligibility Criteria
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
+3 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.
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
6 months
Daily self-monitoring
Follow-up
Participants are monitored for long-term changes in diabetes management and quality of life
4 weeks
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: HealthiExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention
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
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.
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.
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.
Health Internet Technology for Chronic Conditions: Review of Diabetes Management Apps. [2021]Mobile health (mHealth) smartphone apps have shown promise in the self-management of chronic disease. In today's oversaturated health app market, selection criteria that consumers are employing to choose mHealth apps for disease self-management are of paramount importance. App quality is critical in monitoring disease controls but is often linked to consumer popularity rather than clinical recommendations of effectiveness in disease management. Management of key disease variances can be performed through these apps to increase patient engagement in disease self-management. This paper provides a comprehensive review of features found in mHealth apps frequently used in the self- management of diabetes.
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.
[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.
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".
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.
'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.
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.
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.
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 applications for diabetics: a systematic review and expert-based usability evaluation considering the special requirements of diabetes patients age 50 years or older. [2022]A multitude of mhealth (mobile health) apps have been developed in recent years to support effective self-management of patients with diabetes mellitus type 1 or 2.