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FDA Authorizes Interoperable Glucose Monitoring System

G6 patch and devices

G6 CGM patch and reading devices (Dexcom Inc.)

28 March 2018. The Food and Drug Administration authorized a device that electronically monitors blood glucose levels in people with diabetes, but is also designed to exchange data with other compatible electronic systems. The FDA’s action clears the G6 continuous glucose monitoring, or CGM, system made by Dexcom Inc. in San Diego, for use in the U.S. by people with diabetes age 2 and older.

Continuous glucose monitoring is required for people with diabetes, a chronic disorder where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. In type 2 diabetes, which accounts for at least 90 percent of all diabetes cases, beta cells in the pancreas produce some but not enough insulin, or the body cannot process insulin. Type 1 diabetes is an autoimmune disorder where the immune system mistakenly attacks healthy beta cells, shutting down or reducing insulin. According to the International Diabetes Federation, diabetes affects an estimated 425 million people worldwide. FDA cites data indicating nearly 10 percent of the people in the U.S. have diabetes.

The G6 GCM system uses a patch about the size of a U.S. quarter worn on the abdomen to monitor glucose levels in the blood. The patch is calibrated for individual users at the Dexcom factory, and worn for 10 days. During that time, people wearing the patch do not need to confirm readings with drops of blood from finger sticks. Data from the G6 monitor is transmitted to a dedicated device that displays blood glucose readings in real time, or to compatible smartphone or smart watch apps every 5 minutes that also track glucose levels over time.

In addition to mobile devices, the G6 CGM device can also exchange data with other electronic devices for blood glucose management, such as insulin pumps and dosing systems. If blood glucose levels reach dangerously high or low levels, it triggers an alarm, but when connected to an insulin dosing system or pump, those devices adjust insulin levels accordingly. Dexcom sponsored a study, with data published in 2017 that also show people with type 1 diabetes using a CGM monitor have lower blood glucose levels after 24 weeks than comparable individuals receiving the usual care.

FDA says it reviewed earlier stand-alone glucose monitoring systems under its highest risk level, known as class 3 medical devices, requiring more clinical trial data and extended reviews. Since the G6 device is designed to be part of integrated systems, FDA lowered the classification to type 2, for moderate risk devices. However, the agency added special controls to its standard medical device authorization, known as 510(k) clearance, meant to assure the device’s accuracy, reliability, and clinical relevance. FDA says this review process will serve as a template for future reviews of medical devices meeting these criteria.

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