The US Food and Drug Administration (FDA) has permitted the marketing of Dexcom’s G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose levels in children aged two and older and adults with diabetes.
This is the first type of iCGM permitted to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management. The data received can also be shared with five people, which will be particularly useful for parents with young children.
Such authorisation also classifies the device in class II and subjects it to special controls. This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible.
“The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences,” explained Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
“In addition, the FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability.”
“We think G6 carriers a significant improvement in performance by building on the accuracy and reliability that patients have come to expect from Dexcom continuous glucose monitors,” added Chief Executive Kevin Sayer in a conference call with analysts, “including what we believe will be a more consistent experience across all 10 days of use while eliminating the need for routine finger prick calibrations.”
Over 30mn US citizens have diabetes, but many cases remain undiagnosed. The number of American’s over 65 which are diagnosed with diabetes, as well as new cases, are also rising, leading the health condition to remain one of the leading causes of death in the US in 2015.
Whilst CGM systems that were first marketed had a different intended use and were evaluated through the FDA’s premarket approval pathway, the most rigorous review designed for the “highest risk” class III medical devices.
However, the Dexcom G6 system is intended for a more seamless integration with other diabetes devices, and the FDA saw this as an opportunity to reduce the regulatory burden for this type of device. With the authorisation of the Dexcom G6, future iCGMs that meet special controls criteria can go through a more streamlined premarket review.
The size of a quarter, the Dexcom G6 is applied to the skin of the abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid. The device transmits real-time glucose readings every five minutes to a compatible display device such as a mobile medical app on a cell phone and will trigger an alarm when a patient’s blood sugar enters a danger zone. If it’s integrated with an automated insulin dosing system, a rise in blood sugar would trigger the release of insulin from the pump.
It does not require users to calibrate the sensor with fingerstick blood glucose measurements. In addition, it has an updated sensor probe that minimizes interference with the pain reliever acetaminophen.