FDA Expands Indication For Dexcom's G5 CGM For Insulin Dosing
By Jof Enriquez,
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The U.S. Food and Drug Administration (FDA) is permitting the use of Dexcom's G5 Mobile Continuous Glucose Monitoring (CGM) System for insulin dosing without additional finger pricking, making the G5 the first device of its kind to be granted such an approval. Previously, the G5 was cleared for use only as an adjunct to finger-stick testing for patients two years of age and older with diabetes.
FDA based its approval on results from a pair of one-week studies, including 130 adults and children aged two years and older, in which the G5's readings were compared with both glucose meter values and a laboratory reference, according to Medscape. No serious adverse events were reported in those studies.
Dexcom's G5 relies on a small sensor embedded underneath the skin, which continuously monitors blood sugar levels. Through a built-in transmitter, the device sends readings wirelessly to a display device, such as a smartphone or tablet. If blood sugar levels are too high or too low, alarms are triggered, prompting the patient to take action and administer appropriate insulin dosing.
“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions. This may allow some patients to manage their disease more comfortably,” said Alberto Gutierrez, who is director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health (CDRH), reports CBS News.
“Now, people with diabetes who use the Dexcom G5 Mobile CGM system can make daily treatment decisions without having to perform confirmatory finger sticks. And basing their treatment decisions on a number, accompanied by information on speed and direction from the CGM, will greatly improve their decisions over the information provided by blood glucose meters,” said Dexcom CEO Kevin Sayer in a news release.
Sayer said in April before an FDA panel convened that the panel's decision “could very well set the tone for all future CGM products,” and that the company considers FDA approval the first step toward enabling people 65 and older with Medicare to access CGM, as non-adjunctive labeling is a requirement for Medicare coverage.
FDA's clinical chemistry and clinical toxicology advisory panel later voted 8-to-2 in favor of the expanded indication at a July 21 hearing. The panel then designated the G5 system as a replacement to fingerstick glucose testing for diabetes treatment decisions. Now, FDA has followed the panel's recommendation and approved G5 as the first and only CGM system in the U.S. to have a non-adjunctive designation.
“This approval is truly momentous for people like me with diabetes as we can now go up to 12 hours without a painful finger prick, we don’t have to carry a glucose meter everywhere we go, and we can make treatment decisions without lancing our fingers,” said Steven Edelman, MD, Founder and Director, Taking Control of Your Diabetes.