Diabetes Education App for Type 2 Diabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Reading Hospital and Medical Center
Disqualifiers: Pregnancy, Incarceration, No smartphone, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to evaluate the use and effectiveness of a mobile web application (app) that is designed to educate and allow patients to manage diabetes and make sustainable lifestyle changes, and to study the impact of the app on clinical outcomes of diabetes (HA1C) and educational outcomes (Self-Efficacy for Diabetes Scale). The main question to answer is: Does the use of the Diabetes Application significantly affect clinical outcomes of diabetes and cardiometabolic risk factors (BMI and Blood Pressure)? Patients will be enrolled in one of two available arms of the study.
Participants in the 'intervention arm' will use the app to view educational information presented as videos in the following areas: Healthy Coping, Healthy Eating, Staying Active, Medications (Use and Safety), Problem Solving in Diabetes and Disease Pathophysiology. They will continue routine follow-up care with their primary care physicians during the study.
Participants in the 'control arm' will continue with their primary care physician in routine follow-up care, as normally scheduled.
Researchers will compare the intervention arm participants to the control arm participants to find out about and compare changes in HA1C, systolic blood pressure, diastolic blood pressure, and body mass index. Groups will also be compared on the basis of self-perceived confidence of managing their diabetes by way of the Diabetes Self Efficacy Scale.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. However, participants in both study groups will continue their routine follow-up care with their primary care physicians, which suggests you may continue your current medications.
What data supports the effectiveness of the Diabetes Education App for Type 2 Diabetes treatment?
Research shows that using internet and technology-based tools for diabetes education can improve patient outcomes by providing personalized support and helping patients manage their condition more effectively. These tools allow patients to track their health data, receive timely feedback, and connect with healthcare providers and support networks, which can lead to better self-management and improved health outcomes.
12345Is the Diabetes Education App for Type 2 Diabetes safe for humans?
The available research does not provide specific safety data for the Diabetes Education App for Type 2 Diabetes, but similar apps have been tested for usability and feasibility, showing they are generally well-received and promote positive health behaviors.
678910How does the Diabetes Education App for Type 2 Diabetes differ from other treatments?
The Diabetes Education App for Type 2 Diabetes is unique because it provides an interactive and educational platform for self-management, using a mobile or web application to help users learn about and manage their condition effectively. Unlike traditional treatments that may focus solely on medication, this app emphasizes education and self-efficacy, offering tools like quizzes and a diabetes dictionary to enhance users' understanding and control of their diabetes.
610111213Eligibility Criteria
This trial is for adults over 18 with uncontrolled Type 2 Diabetes (HA1c >8.0) who are patients at the Family Healthcare Center, Reading Hospital Tower Health. It's not for pregnant individuals, incarcerated people, those without a smartphone, or anyone unable to consent.Inclusion Criteria
Current patients of the Family Healthcare Center, Reading Hospital Tower health.
I have Type 2 Diabetes with an HA1c level above 8.0.
I am 18 years old or older.
Exclusion Criteria
I am able to give my own consent to participate in the study.
Identified special populations (pregnancy or individuals currently incarcerated)
Patients without access to their own smart phone
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants in the intervention arm use the diabetes education app for 6 months, while control arm participants continue routine care
6 months
Routine follow-up appointments with primary care physicians
Follow-up
Participants are monitored for changes in HA1C, blood pressure, BMI, and self-efficacy for diabetes management
6 months
Participant Groups
The study tests a diabetes education app that provides videos on managing diabetes and lifestyle changes versus usual care without the app. The impact on blood sugar control (HA1C), body weight, blood pressure, and self-management confidence is measured.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment1 Intervention
Participants enrolled in the intervention arm will be given a 6-month access period to the diabetes education application designed by the study team. The web site will offer videos related to a specific areas of education concerning diabetes self-management. To encourage compliance, participant users will receive weekly notifications from the application that will guide them through viewing all videos in the series. Participants will continue routine follow-up appointments with their primary care physicians during the study period. There will be no restrictions on starting or stopping medications during the study period.
Group II: Control armActive Control1 Intervention
Participants in the control arm will not have access to the Diabetes Application. They will continue follow-up appointments according to the standard of care with their primary care physician, diabetic educators, etc. There are no restrictions on starting or stopping medications for patients within the control arm.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Reading Hospital, an affiliate of Tower HealthWest Reading, PA
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Who Is Running the Clinical Trial?
The Reading Hospital and Medical CenterLead Sponsor
Reading Hospital FoundationCollaborator
Complete Statistical Services (Consult-Stat)Collaborator
References
Evaluation of the quality and contents of diabetes mellitus patient education on Internet. [2019]Patient education is widely regarded as an essential component of chronic disease care and effective health promotion. Internet is extremely useful medium in this respect. Web-based information is seldom the subject of systematic investigation for its accuracy and appropriateness for patients. Objective of this study was to evaluate of web-based diabetes patient education material for well-accepted evaluation criteria and core education concepts. Out of 214 web-sites retrieved from meta search engine, 53 sites themselves provide patient information and so considered for evaluation. Data obtained was analyzed by cluster analysis and classified into four categories with respect to quality. Considerable variability in quality of diabetes patient education web-sites was found with respect to core educational concepts and HSWG criteria. Inclusion of evidence-based medicine concepts, role of family support, enhancement in customized content and easier feedback mechanism in the web-sites can be a significant development in the direction of patient-centered diabetes care.
Development and evaluation of a patient-oriented education system for diabetes management. [2022]To develop and evaluate a Web-based, patient-orientated diabetic education management (POEM) system.
E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials. [2022]Label="AIMS">Patient-centered education improves glycemic control in subjects with type 1 diabetes (T1D). E-health technologies are widely used to support medical decision-making, patient advising or teleconsultations; however, the active participation of a patient is missing. Challenges remain whether e-health education can be effectively incorporated into clinical pathways. The purpose of the study was to examine the effects of e-health education, compared to standard care, on HbA1c. MATERIAL AND METHODS: We conducted a literature search (EMBASE, MEDLINE, The Cochrane Library and Web of Science) up to February 2018 for randomized controlled trials (RCTs) of Internet-/ mobile application-based educational interventions, with the active involvement of patients, provided in addition to, or substituting usual care in patients with T1D on intensive insulin therapy. The primary outcome was the standardized difference in means (SDM) of HbA1c change from baseline between intervention and comparator groups.
A review of web-assisted interventions for diabetes management: maximizing the potential for improving health outcomes. [2022]Current endeavors in diabetes care focus on helping patients and providers deal successfully with the complexities of the disease by improving the system of care, expanding the reach of interventions, and empowering patients to engage in self-care behaviors. Internet technologies that combine the broad reach of mass media with the interactive capabilities of interpersonal media provide a wide range of advantages over standard modes of delivery. The technical affordances of Web delivery enable individualization or tailoring, appropriately timed reinforcement of educational messages, social support, improved feedback, and increased engagement. In turn, these have been significantly correlated with improved health outcomes.This article is a narrative review of Web-based interventions for managing type 2 diabetes published from 2000 to 2007 that utilize Web sites, Web portals, electronic medical records, videoconference, interactive voice response, and short messaging systems. The most effective systems link medical management and self-management. Patient satisfaction is highest when the Web-based system gives them the ability to track blood glucose, receive electronic reminders, schedule physician visits, email their health care team, and interact with other diabetic patients. However, comprehensive medical and self-management programs have not been implemented widely outside of systems funded by government agencies. The cost of developing and maintaining comprehensive systems continues to be a challenge and is seldom measured in efficacy studies. Lack of reimbursement for Web-based treatments is also a major barrier to implementation. These barriers must be overcome for widespread adoption and realization of subsequent cost savings.
Internet and information technology use in treatment of diabetes. [2022]This chapter contains clinical studies and reviews of the state-of-the-art regarding how information technology can help improve outcomes for patients with diabetes through enhanced education and support. With the increasing sophistication of diabetes treatment protocols and diabetes-related devices this new modality offers a remarkable opportunity for clinicians and patients. For the first time, with online tools clinicians are in a position to have a major impact on diabetes outcomes by providing robust and affordable just-in-time support to large numbers of patients who want to improve their diabetes outcomes through enhanced self-management of the complex behaviours so essential for good outcomes. Patients with diabetes often need a complex set of services and support ranging from glucose monitoring, insulin and other medication management, psychotherapy and social support, to physical activity promotion, nutrition counselling and more. Integrating these supports into a patient's therapeutic regimen presents challenges that need to be addressed through a variety of strategies. Patient self-management of diabetes enabled by information technology is becoming an important factor in the way providers deliver healthcare. Approaches using information technology to support clinical services are being dramatically altered by the confluence of several trends. * Patients want an active role in managing their own health and a collaborative relationship with their healthcare providers. * Widespread, low-cost internet access is erasing existing geographic, economic and demographic barriers to obtaining health information online, and with advanced Web 2.0 technologies high levels of interactivity can engage the patient. * Clinicians and researchers now have a deeper understanding of how people learn and respond online, and that knowledge can be crafted into solutions that produce effective, long-term behaviour change. Technology enabled approaches that show great promise to improve outcomes use new models of service provision in which technology enabled self-management support (SMS) provides patients with * just-in-time delivery of tailored messages and experience that speak to each person based on their unique characteristics, their performance on key behaviours and their needs at that moment in time; * ways to easily and accurately keep track of their performance and use that knowledge to plan and implement new approaches to reaching their goals; * ways to link directly to family and friends for critical support, and to link to their many providers to help integrate medical care with everyday life. Online tools can extend health practices and provide this support through cost-effective programmes that help clinicians guide their patients to better manage their diabetes. The best internet self-management education and support programmes are rich in pertinent content, provide engaging interactive elements, and offer a tailored, personalised learning experience. They contain self-assessment tools and ways for the individual to monitor performance and changes in biological measurements such as blood sugar, insulin dosage, physical activity, weight, blood pressure and mood. The patient can access their information, input their data, and receive support 24 h a day - at a time and place most convenient for them, and not limited to clinicians' office hours. Web-based learning and support technology benefits both clinician and patient; patients learn to overcome barriers and to self-document activities and interactions, permitting clinician review and feedback at any time. In addition to automating much of the educational content, this time shifting element is one of the keys to making the process efficient and low cost. The ability to perform an automated review of the patient's activities and performance also provides the clinician with a valuable tool that increases both effectiveness and efficiency. As with online intervention, a 'virtual coach' can provide individualised guidance and support based on readily available analyses of each patient's characteristics and performance. In addition, the clinician can communicate frequently and efficiently, offering personalised email support to each patient without requiring in-person meetings, as well as monitor 'virtual support groups' where patients interact with others online via informational chat rooms and blogs. By incorporating web-based patient self-management and support into traditional treatment methods, one clinician can effectively support many patients - one patient at a time.
New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. [2023]Diabetes self-management education is essential at the time of diagnosis. We developed the New-Onset Diabetes Educator (NODE), an animation-based educational web application for type 1 diabetes mellitus patients.
Adherence to evidence-based guidelines among diabetes self-management apps. [2021]Smartphone apps can provide real-time, interactive self-management aid to individuals with diabetes. It is currently unclear whether existing diabetes self-management apps follow evidence-based guidelines. The purpose of this study was to evaluate the extent to which existing diabetes self-management apps address the seven self-management behaviors recommended by the American Association of Diabetes Educators (the AADE7™). The term "diabetes" identified relevant self-management apps via the Apple App Store search engine in March 2012. Ratings were based on app descriptions and downloads. Chi-square analyses assessed differences in apps based on developer type. Apps promoted a median of two AADE7™ skills. Overall reliability between description and download ratings was good (kappa = .66). Reliability of individual skills was variable (kappa = .25 to .91). Most diabetes apps do not conform to evidence-based recommendations, and future app reviews would benefit from testing app performance. Future apps may also benefit from theory-based designs.
The Development of a Diabetes Application for Patients With Poorly Controlled Type 2 Diabetes Mellitus. [2019]The prevalence of patients with diabetes mellitus has increased in recent years. This has resulted in increased demand for face-to-face diabetes education by diabetes nurse clinicians. The use of mobile-health technologies in diabetes education is an innovative way of learning and has the potential to engage patients and influence positive health behaviors, including meeting desired goals and diabetes-related outcomes. The aim of the study was to develop and test the usability and feasibility of an empirical diabetes application for patients with type 2 diabetes mellitus. The mobile-based, gamified Diabetes Application was developed based on a full systems development life-cycle framework. Eight patients with poorly controlled type 2 diabetes mellitus completed a pilot study that consisted of a postapplication survey to assess the usability and feasibility of the diabetes application. The findings affirmed the usefulness and feasibility of the diabetes application for patients with diabetes mellitus. It increased awareness, enriched knowledge, promoted user engagement, motivated positive behaviors, and affirmed patient belief in diabetes self-management. This article discusses the development and evaluation of the diabetes application, including modifications made based on the results of the pilot study.
Computer-based remote diabetes education for school personnel. [2006]Teachers are expected to respond quickly and accurately to any diabetes incident that may occur to children in the school setting. Access to diabetes information is crucial for student safety, health, academic achievement, and social competence. This paper describes a technique to provide Web-based diabetes information using computer audio and video to enrich a text-based training experience. Two groups of teachers were presented with diabetes training material via either paper or a Web-based computer system. Both groups were then evaluated for diabetes knowledge and satisfaction. Subjects using the Web-based system had significantly (t = 2.22; p
Six-month Outcomes of Mobile Phone Application-based Self-management in a Patient with Type 2 Diabetes. [2020]We report the case in order to examine the effect of a mobile application program ("Diabetes & Nutrition") developed in 2011-2012 for self-management in patients with type 2 diabetes and to recommend important considerations when the mobile application program is developed. A 46-year-old man was newly diagnosed with type 2 diabetes in 2013 and had no complications. The height of the patient was 168 cm and the body weight was 75.6 kg. Nutrition education was conducted according to a medical prescription, and follow-up nutrition education was conducted after 3 and 6 months. After nutrition education, the patient was engaged in self-management using "Diabetes & Nutrition" program during 3 months. At 3 months, the body weight had decreased by 4.4 kg (from 75.6 to 71.2 kg), waist circumference by 5 cm (from 88 to 83 cm) and HbA1c level from 7.9% to 6.1%. Also at 3 months, the medication was reduced from from the dose of 850 mg to the dose of 500 mg metformin per twice a day. Since then, the patient did not continue to use the "Diabetes & Nutrition" because the level of blood glucose had stabilized, and the patient felt inconvenient and annoying to use the program. At 6 months, no significant change in the body weight and body composition was observed in comparison with those at 3 months. The present case demonstrates that the early use of "Diabetes & Nutrition" could be helpful for self-management of glycemic control in patients with type 2 diabetes. Developing self-management mobile application programs in the future will require strategies of how to promote continuous use of application program and self-management of type 2 diabetes.
Interactive educational diabetes simulators: future possibilities. [2011]In 1996 an interactive educational diabetes simulator called AIDA was released without charge on the Internet as a non-commercial contribution to continuing diabetes education. Over the past 3 years over 30,000 people have visited the AIDA Web site-- http://www.diabetic.org.uk/aida.htm--and over 10,000 copies of the program have been downloaded from there free-of-charge. This review builds on the experience gained from the AIDA development and the World Wide Web distribution of the software, and looks to the future, highlighting features which users might expect to see in future generations of such interactive educational diabetes programs. Novel functions already described in the literature are overviewed, and possible applications using personal computers and the Internet are discussed. The importance of the user interface is stressed. The concept of a "virtual diabetic patient" that provides an electronic representation of a patient with diabetes--and which can be used for self-learning/teaching/demonstration purposes--is highlighted.
Interactive Multimedia Tailored to Improve Diabetes Self-Management. [2015]A pilot program was initiated to improve self-management of type 2 diabetes by rural adults. Using an iOS-based, individually tailored pre-/postintervention to improve diabetes self-management, undergraduate students developed a native mobile application to help participants effectively manage their diabetes. Brief quizzes assessed diabetes knowledge. A diabetes dictionary and physical activity assessment provided additional support to users of the app. On completion of the pilot, data analysis indicated increased diabetes knowledge and self-efficacy, and ease of use of the technology. Native app technology permits ready access to important information for those living with type 2 diabetes.
The freeware AIDA interactive educational diabetes simulator--http://www.2aida.org--(2). Simulating glycosylated haemoglobin (HbA1c) levels in AIDA v4.3. [2007]In 1996 an interactive educational diabetes simulator called AIDA was released without charge on the Internet as a non-commercial contribution to continuing diabetes education. Over the past 4+ years over 74,000 people have visited the AIDA Web pages at http://www.2aida.org and over 20,000 copies of the program have been downloaded from there free-of-charge. This article builds on the experience gained from the AIDA development, and the World Wide Web distribution of the software, and highlights some of the problems which users have reported with the program. An updated release of the software (AIDA v4.3) is described and the method applied for modelling glycosylated haemoglobin (HbA1c) levels within this new version of AIDA is documented. An overview is provided of the trialling and beta-testing of this latest release of the program, and the general concept of a 'virtual diabetic patient' that provides an electronic representation of a patient with diabetes--and which can be used for self-learning/teaching/demonstration purposes--is highlighted.