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
Open accessAbstract
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 standardize 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 organizations. We found that, across the U.S. 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 organizations, including the International Medical Device Regulators Forum and the World Health Organization, 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, policy makers, professional organizations, researchers, people with diabetes, and health care 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 standardization, and insufficient data security. We conclude with a series of recommended actions to resolve some of these shortcomings.
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The available evidence on the effectiveness of DM-specific mHealth apps is limited.
“However, the available evidence on the effectiveness of DM-specific mHealth apps is limited [39].”
From Effectiveness of Disease-Specific mHealth Apps in Patients With Diabetes Mellitus: Scoping Review (2021) · cites this paper as [39]
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Self-citation
- Authors
- Fleming, G. A., Petrie, J. R., Bergenstal, R. M., Holl, R. W., Peters, A. L., & Heinemann, L.
- Affiliations
- Kinexum, Harpers Ferry, WV
- University of Glasgow (GB)
- Park Nicollet Health Services (US)
- Universität Ulm (DE)
- University of Southern California (US)
- Science-Consulting in Diabetes GmbH, Neuss, Germany
- Corresponding author
- Fleming, G. Alexander
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2019-12-12
- Volume
- 43
- Issue
- 1
- Pages
- 250-260
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W2994039809
- Cited by
- 306
- References
- 40
- Citations by year
- 2026: 28 · 2025: 45 · 2024: 59 · 2023: 44 · 2022: 50 · 2021: 51 · 2020: 26 · 2019: 1 · 2018: 1 · 2017: 1
- FWCI
- 43.60
- Type
- journal article
- Language
- en
- Open access
- green
- eprints.gla.ac.uk
- Licence
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Keywords
- diabetes apps, mobile health, digital health technologies, diabetes self-management, medical device regulation, clinical validity, interoperability, data security, patient safety, regulatory standards, health technology policy
- MeSH terms
- Smartphone, Blood Glucose, Computers, Diabetes Mellitus, Endocrinology, Europe, Humans, Insulin, Insulin Infusion Systems, Monitoring, Physiologic, Societies, Medical, United States, Blood Glucose Self-Monitoring, Inventions, Mobile Applications
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