Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group
The number of digital and health applications to help patients manage diabetes is increasing recently. However, there is limited evidence available on the safety and effectiveness of mobile health apps for diabetics. The author Fleming and colleagues (2020) published a paper under the title “Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group” in the American Diabetic Association. The summary is below:
Objectives:
To provide evidence-based recommendations to ensure the safety and efficacy of developing diabetes digital health field.
Method:
A joint review was conducted by EASD and ADA for the available diabetes digital health technology and practices of regulatory authorities and organizations.
Recommendations:
1) Recommendations for Regulatory agencies:
• Standards that can be followed by digital health technology developers at premarketing and post-marketing stages should be designed and updated. It can include components of clinically validated information, effectiveness variables that can increase outcomes, user-friendly system services, and data transferable function to other devices while supporting market innovation.
• Regulatory criteria should be provided that can be modified as per software.
• Guidelines should be provided for acquiring and promoting different performance measures.
• Security, accuracy, and reliability of digital health apps should be analyzed in different ways. It should include even small supporting companies to generate real-world data if they have a product that has achieved a standard.
• A single publicly accessible international database should be provided and maintained about all available digital health apps and including parameters that would measure their utility/quality and how these parameters would be assessed.
• Regulatory activities should be summarized and published yearly
• Work to harmonize their activity
2) Recommendations for Manufacturing Companies
• Obey the regulations, industry standards, and best practices established for digital health app development and marketing.
• Documentation, training modules, and help-desk resources should be sufficiently maintained to assure optimal use.
• Interfaces should be user-friendly across all demographic groups. And can be individualized with real-time insights and suggestions for individual users.
• Report all safety-related data punctually and transparently to the regulatory authorities.
• Cooperate with academics and health care professionals (HCPs) to handover balanced reliable information for people with diabetes and package the output data in standardized formats that can be easily accessible in electronic health records.
• Encourage users to submit their data anonymously to help track outcomes and demographics by using crowdsourcing model.
• To maintain patient confidentiality through the incorporation of a high degree of data security.
3) Recommendations for international and national professional societies:
• Organize a meet for people with diabetes, manufacturing companies, HCPs, and regulatory authorities to ease digital health technology interventions.
• Motivate for advanced researches to academia and medical associations for investigating effectiveness, safety, and outcomes of digital health app
• Spread knowledge in the context of the strengths and limitations of digital technology among HCPs and consumers.
• Put forward evidence-based guidelines on the effective functioning of digital health interventions.
• To make diabetes patients benefitted from digital health apps; recommend suitable forms of structured education for HCPs, to support patients regarding the apps.
• Formulate a list of endorsed apps that can provide a threshold of accuracy, dependability, and ease of use for both, HCPs and people with diabetes.
4) Recommendations for international and national research funding bodies:
• Offer funding for well-structured independent clinical studies that are planning to measure effectiveness, safety, outcomes, and use of digital technology in real-world settings.
• Offer significant financial support for long-term data collection.
5) Recommendations for researchers/academics:
• Report and share the patient-level results of all clinical evidence publicly
• Design and validate specific and appropriate patient-related outcome measures
6) Recommendations for HCPs:
• Be aware of the strengths and weaknesses of digital health apps.
• Support and advice patients with diabetes for the use of digital health apps to ease their journey of diabetes management and lifestyle modification.
• Utilize health data to improve quality of care and health outcomes
7) Recommendations for consumers of digital health apps (people with diabetes, family members, caregivers)
• Look forward to digital health apps as a valuable addition to disease management or prevention.
• Before choosing from available digital health app options, discuss with their HCPs. Additionally, discuss advice or counselling acquired from the app that can affect behavior or care decisions.
• Submit reviews about the functioning of apps and also report apps that appear to be unsafe or illegally marketed, to the manufacturers and appropriate regulatory agencies and care organizations.
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