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

Abstract

Digital health technology, especially digital and health applications ('apps'), have been developing rapidly to help people manage their diabetes. Numerous health-related apps provided on smartphones and other wireless devices are available to support people with diabetes who need to adopt either lifestyle interventions or medication adjustments in response to glucose-monitoring data. However, regulations and guidelines have not caught up with the burgeoning field to standardise how mobile health apps are reviewed and monitored for patient safety and clinical validity. The available evidence on the safety and effectiveness of mobile health apps, especially for diabetes, remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore conducted a joint review of the current landscape of available diabetes digital health technology (only stand-alone diabetes apps, as opposed to those that are integral to a regulated medical device, such as insulin pumps, continuous glucose monitoring systems, and automated insulin delivery systems) and practices of regulatory authorities and organisations. We found that, across the USA and Europe, mobile apps intended to manage health and wellness are largely unregulated unless they meet the definition of medical devices for therapeutic and/or diagnostic purposes. International organisations, including the International Medical Device Regulators Forum and WHO, have made strides in classifying different types of digital health technology and integrating digital health technology into the field of medical devices. As the diabetes digital health field continues to develop and become more fully integrated into everyday life, we wish to ensure that it is based on the best evidence for safety and efficacy. As a result, we bring to light several issues that the diabetes community, including regulatory authorities, policymakers, professional organisations, researchers, people with diabetes and healthcare professionals, needs to address to ensure that diabetes health technology can meet its full potential. These issues range from inadequate evidence on app accuracy and clinical validity to lack of training provision, poor interoperability and standardisation, and insufficient data security. We conclude with a series of recommended actions to resolve some of these shortcomings.

Research Implications for Future Telemedicine Studies and Innovations in Diabetes and Hypertension—A Mixed Methods Study

“…Our results support and emphasize the recommended systematic and structured guidelines for digital health apps as well as an improved evidence base for digital health interventions by ADA and EASD [73]. Additionally, our results show that considering Patient-Reported Outcomes, supporting implementation science and continuously involving end-users in the development process of digital health interventions (user-centered design) are seen as relevant strategies, which is in line with the evidence tiers of the recently published NICE framework for digital health evaluation [74].…”

Precision medicine in diabetes: a Consensus Report from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

“…This first Consensus Report does not seek to address extensively the role of precision medicine in the complications of diabetes, which is a topic for future evaluation. In addition, we do not discuss diabetes digital device technology, as this is addressed in a joint ADA/EASD consensus report [8,9]. A second PMDI consensus report will be published documenting the findings of a systematic evidence review, focusing on precision diagnostics and precision therapeutics (prevention and treatment).…”

Adherence to the National Guidelines for Follow-Up Protocol in Subjects with Type 2 Diabetes Mellitus in Greece: The GLANCE Study

“…On the other hand, the rapid evolution in digital solutions for diabetes management could further support patient followup protocols and improve outcomes [41]. However, as highlighted by the EASD and the ADA Diabetes Technology Working Group, several issues regarding the standardisation of diabetes digital applications should be addressed so that they can be validated in terms of their clinical significance and ensure patient safety and data privacy [42].…”