FDA seeks feedback on digital tools for diabetes

The FDA has initiated a comment period until the end of the month, seeking input on the deployment of digital health technologies (DHTs) to prevent, detect, and manage diabetes. Led by Troy Tazbaz, the director of the FDA’s Digital Health Centre of Excellence (DHCoE), the consultation aims to involve various stakeholders, including patients, researchers, healthcare providers, technology companies, and standards organisations. The FDA is particularly interested in refining regulations for digital interventions that extend care into homes and communities, contribute to early detection and prevention of diabetes, and potentially reverse type 2 diabetes. The agency emphasises the potential of DHTs, including those enabled by artificial intelligence/machine learning (AI/ML), to transform healthcare delivery and improve outcomes, especially in diverse populations.

With one in 10 Americans having diabetes, and one in five being unaware of their condition, the FDA recognises the need for enhanced efforts to address this public health challenge. Certain racial and ethnic groups, such as Black, Hispanic, and Native American people, face higher diabetes risks but are less likely to be diagnosed and receive effective care. Tazbaz highlights the opportunity for digital health to identify diabetes earlier, particularly in socioeconomically disadvantaged or geographically isolated communities lacking access to healthcare services. The FDA aims to work collaboratively with stakeholders to leverage DHTs in extending the reach of the healthcare system beyond traditional clinics and advancing better measurement, understanding, and management of health for individuals impacted by type 2 diabetes.

According to the American Diabetes Association (ADA), the total cost of diagnosed diabetes in the US in 2022 was nearly $413 billion, comprising direct costs of around $307 billion and indirect costs of $106 billion. Individuals with diagnosed diabetes incur medical expenditures approximately 2.6 times higher than those without the disorder, emphasising the economic impact of diabetes on the healthcare system.