Diabetes apps require additional validation, education on their use, consensus report finds
Clinicians should be aware of the strengths and weaknesses of diabetes apps and be able to advise patients on their use, according to the European Association for the Study of Diabetes and the American Diabetes Association.
Mobile apps intended to manage health and wellness, including diabetes, are largely unregulated unless they meet the definition of medical devices for therapeutic and/or diagnostic purposes, a consensus report found, Issues range from inadequate evidence on their accuracy and clinical validity to lack of training for clinicians and patients.
The consensus report was issued by the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group and addressed stand-alone apps, rather than those that are part of a medical device. It was published by Diabetes Care on Dec. 5 and Diabetologia on Dec. 4.
The report identified nine major issues requiring attention by regulatory authorities, policymakers, professional organizations, researchers, product manufacturers, and health care clinicians, including availability of evidence on apps' efficacy, accuracy, clinical validity, and quality; training and maintenance issues; interoperability and standardization; usability for diverse patient populations (including older and less tech-savvy patients); data security/privacy; and the role of clinicians and professional organizations in app use and development.
Clinicians should be knowledgeable about digital health apps and their strengths and weaknesses, support and inform people with diabetes on the use of digital health apps to augment diabetes management and lifestyle modification, and use health data to improve quality of care and health outcomes, the report said. It recommended that international and national professional societies advance research in digital health app effectiveness, safety, and outcomes; help set expectations for clinicians and patients regarding the strengths and limitations of digital technology; and provide evidence-based guidelines on the effectiveness of digital health interventions.
“Apps are converging toward a data-capturing and auto-analyzed future with algorithm-based recommendations for users affecting their behavior and decisions,” the report concluded. “We call upon regulatory agencies and manufacturing companies to work urgently and collaboratively with health professionals, researchers, and people with diabetes to create an environment in which diabetes can be managed safely and effectively, bringing benefits to all stakeholders and the entire diabetes community.”