FDA Approval of Dexcom's Non-Adjunctive Indication Triggers a New Era in Diabetes Management

The Dexcom G5 Mobile CGM System is the first and only medical device that is FDA-approved for making daily diabetes decisions without painful finger pricks.

SAN DIEGO--(BUSINESS WIRE)-- Dexcom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the U.S. Food and Drug Administration (FDA) has approved its G5 Mobile CGM system as the first and only continuous glucose monitoring system that can be used to make daily diabetes treatment decisions without finger pricking. The new "non-adjunctive" indication expands use of the Dexcom G5 Mobile CGM system as a replacement to finger stick glucose testing for diabetes treatment decisions, positioning the device as the new standard of care in glucose monitoring for diabetes management. With the new label indication, the Dexcom G5 CGM System only requires two finger pricks per day for calibration.

"The expanded indication for the Dexcom G5 Mobile CGM system is an astounding milestone for people with diabetes and it is a critical step to advancing diabetes technology that will drastically change diabetes management," said Kevin Sayer, Dexcom President and Chief Executive Officer. "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."

In July, an FDA selected panel of experts determined that the Dexcom G5 Mobile CGM system is safe, effective and the benefits outweigh the risks with the proposed indications for use. The FDA has followed the expert recommendation and made the Dexcom G5 Mobile CGM system the first and only CGM system in the U.S. to have a non-adjunctive designation. Dexcom's CGM system is widely recognized as the most accurate and most popular CGM in the world.

"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. "It completely changes the way that we manage our diabetes and gives us a chance to gain much better control of the disease without all of the pain and hassle of constant finger sticks."

The approval is also the first step toward enabling people 65 and older with Medicare to access CGM, as non-adjunctive labeling is a requirement for Medicare coverage.

About Diabetes and Continuous Glucose Monitoring

With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.i,ii

Continuous glucose monitoring (CGM) is considered the most significant breakthrough in diabetes management in the past 40 years.iii CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose is too low or too high with built-in and customizable alarms. A recent study showed that after one year, patients with type 1 diabetes who used CGM alone had significant A1C reductions regardless of the type of insulin delivery method used, including insulin pumps.iv

About DexCom, Inc.

Dexcom, Inc., headquartered in San Diego, CA, is dedicated to helping people better manage their diabetes by developing and marketing continuous glucose monitoring (CGM) products and tools for adult and pediatric patients. With exceptional performance, patient comfort and lifestyle flexibility at the heart of its technology, users have consistently ranked Dexcom highest in customer satisfaction and loyalty. For more information on the Dexcom CGM, visit www.dexcom.com.

*A minimum of two finger sticks per day are still required to calibrate the CGM system.


i Hyperglycemia (High blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html. Updated August 5, 2013. Accessed December 3, 2013.

ii Hypoglycemia (Low blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Updated July 16, 2013. Accessed December 3, 2013.

iii Clarke SF and Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus.
Br J Biomed Sci. 2012;(3)2:83-93.

ivJ. Soupal, J. Skrha Prazny, M. Flekac, L. Petruzelkova, J. Skrha, et al. Comparison of different treatment modalities for Type 1 diabetes including Sensor-Augmented Insulin Regimens (SAIR), in 52 weeks of follow ups: A COMISAIR Study. Diabetes Technology and Therapeutics. Vol 18, No. 9, Sept. 2016.

Dexcom, Inc.
Caren Begun, 201-396-8551
Steve Pacelli, 858-200-0200

Source: Dexcom, Inc.

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