A San Diego company’s product will be the first to replace finger-stick testing for determining insulin doses for diabetes patients, the U.S. Food and Drug Administration announced today.
DexCom Inc., one the largest local medical device makers in San Diego, won approval for the use of its continuous glucose monitoring (CGM) system to determine insulin doses. This is the first time in history that the FDA has cleared a CGM system to replace finger-stick testing.
The decision officially expands the indication for Dexcom's G5 Mobile Continuous Glucose Monitoring System, previously approved only as an adjunct to finger-stick testing, for diabetes treatment decisions in patients 2 years of age and older with diabetes.
“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,” Alberto Gutierrez, an FDA official said in a statement. “This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their health care providers about the use of real-time continuous glucose monitoring in diabetes management.”
Because the body's ability to control blood sugar levels is impaired in people with diabetes, patients must regularly test and monitor their blood sugar. This is traditionally done with a finger-stick sample taken several times a day, which is then tested with a blood glucose meter. Results indicate if glucose levels are too high or too low, helping patients make dosing decisions.
DexCom’s CGM system uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels. Results are sent wirelessly every five minutes to a dedicated receiver and a compatible mobile device such as a smartphone running a mobile app. The patient is then alerted with alarms if the glucose levels are above or below the user-set thresholds.
The FDA approval could pave the way for Medicare to allow reimbursement for CGM systems, because CGM’s were previously considered an adjunct device for treatment.
DexCom’s stock (Nasdaq: DXCM) is up nearly 2 percent Wednesday morning on the news. The company has a market cap of $5.5 billion and its stock is currently trading for $64.75 per share.