American Diabetes Association® Statement on May 16, 2019 FDA Warning on DIY Diabetes Devices

Statement from William T. Cefalu, MD, Chief Scientific, Medical and Mission Officer: 
Diabetes is a highly individual and complex chronic health condition, and as detailed in the American Diabetes Association’s (ADA’s) Standards of Medical Care in Diabetes, it requires a personalized diabetes care plan that can meet the needs of each person living with diabetes to provide optimal blood glucose control, decrease the risk of serious complications, and improve quality and length of life. The ADA appreciates the innovation and creativity of the DIY (do-it-yourself) community to develop new devices and technologies that can help improve blood glucose management, and many advances have originated from this community’s commitment to safety and individualization for each person’s diabetes. In light of a recent report of a serious, life-threatening adverse event related to the use of a non-FDA-approved device and algorithm and the FDA’s May 16, 2019 warning, the ADA strongly recommends that people with diabetes work closely with their diabetes care team to ensure the device they are using can safely manage their blood glucose levels or to enroll in an appropriate clinical trial where they can receive support in the use of devices still in development. An expedited approval process for new diabetes devices that can allow safe, personalized diabetes management for each individual is required.

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, About the American Diabetes Association

Every day more than 4,000 people are newly diagnosed with diabetes in America. Nearly 115 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation’s leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For nearly 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).