Abstract

A large percentage of the diabetes population in the U.S. is over the age of 65. Elderly individuals with diabetes are at the greatest risk for hypoglycemia. Two U.S. regulatory agencies, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS), are responsible for protecting the safety of these individuals by providing access to safe and effective diabetes treatment. Self-monitoring of blood glucose is a key component of diabetes management; however, neither the FDA nor CMS are meeting their obligations to ensure access to accurate glucose monitoring systems. This article presents an overview of these failings and discusses how medical associations and patient advocacy groups are working to address this troubling situation.

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