Dexcom Announces FDA Clearance of New Dexcom G6 Pro CGM
October 08 2019 - 8:30AM
Business Wire
First and only single-use, professional CGM
system with blinded or unblinded mode
Dexcom, Inc. (NASDAQ:DXCM) announced today the U.S. Food and
Drug Administration (FDA) has cleared the Dexcom G6 Pro Continuous
Glucose Monitoring (CGM) System for healthcare professionals to use
with their patients, ages two years and up.
Dexcom G6 Pro is the first and only single use, professional CGM
that gathers real-time glucose data over a 10-day period and offers
both a blinded and unblinded mode. In blinded mode, real-time
glucose data is hidden from the patient and reviewed
retrospectively with their healthcare professional at the end of
the session. In unblinded mode, patients can see their glucose data
throughout the 10-day sensor wear to gain insights and make
treatment decisions in real time.
Regardless of mode, glucose data gathered by the Dexcom G6 Pro
enables providers to adjust a patient’s diabetes therapy plan with
precision and customization. Providers can also use the data to
help patients modify their daily behavior after seeing the effects
that variables such as food, exercise, stress and medication have
on glucose levels.
“Dexcom G6 Pro will enable healthcare providers to set up their
patients with CGM in minutes,” said Davida Kruger, MSN, APN-BC,
BC-ADM, diabetes specialist, Division of Endocrinology, Diabetes,
Bone and Mineral Disorders at Henry Ford Health System in Detroit.
“This new professional system will serve as a simple way to obtain
data from CGM naïve patients who need glucose insight, but don’t
need or want to be monitored around the clock. It will give all my
patients a chance to try the Dexcom G6 Pro under a healthcare
provider’s supervision before they commit to a personal
system.”
Dexcom G6 Pro features and benefits:
- Easy sensor applicator – Allows for one-touch, simple
insertion
- Single-use, disposable sensor – Simplifies session start and
end for both patients and providers
- Auto-start transmitter – Expedites startup time to get patients
on CGM quickly and easily
- Blinded or unblinded mode –
- Blinded: patients wear a sensor for 10 days, then return to
their physician’s office to review the data retrospectively
(indicated for assessing glycemic variability in persons age two
years and up)
- Unblinded: patients can view glucose data in real-time on a
simplified mobile app* throughout the 10-day sensor wear (indicated
for management of diabetes, in persons age two years and up)
- Continuous glucose readings – Reads glucose values
automatically every five minutes
- Alerts and alarms – Warns user of dangerous high and low
glucose levels (unblinded mode only)
- Fingerstick elimination – No fingersticks needed for
calibration or diabetes treatment decisions†
- Dexcom CLARITY – Allows providers to pull interactive reports
and review glucose patterns, trends and statistics retrospectively
with their patients
“At Dexcom, we are continuing to drive innovation in wearable
health technology,” said Kevin Sayer, president, CEO and chairman
of Dexcom. “Using the power of Dexcom G6 Pro, clinicians can use
the insights gained from a 10-day professional CGM session to
adjust treatment plans and empower their patients to live healthier
lives.”
The company expects to begin shipping Dexcom G6 Pro early next
year. For more information, visit www.dexcom.com/g6pro.
About CGM
CGM devices are considered the most significant breakthrough in
diabetes management in the past 40 years1 and Dexcom has been a
leader of those innovations. Diabetes affects nearly 30 million
Americans and is the seventh leading cause of death in the United
States2. The traditional standard-of-care for glucose monitoring
has been a fingerstick meter, which is painful as some patients
needed to test their blood up to 12 times a day. 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 levels are too low or too high.
People with diabetes who take insulin must monitor their blood
glucose levels frequently. Uncontrolled glucose can cause health
complications and even death3,4. To learn more about CGM, visit
www.dexcom.com.
About Dexcom, Inc.
Dexcom, Inc., headquartered in San Diego, 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 about
Dexcom CGM, visit www.dexcom.com.
_____________________________
* If your glucose alerts and readings from the Dexcom G6 do not
match symptoms or expectations, use a blood glucose meter to make
diabetes treatment decisions.
† For a list of compatible devices, visit
www.dexcom.com/compatibility.
1. 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.
2. 2014 National Diabetes Statistics Report. Centers for Disease
Control and Prevention.
http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf.
Accessed March 31, 2015.
3. 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.
4. 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.
Dexcom, Dexcom G6, and Dexcom CLARITY are registered trademarks
of Dexcom, Inc. in the United States and/or other countries. ©2019
Dexcom Inc. All rights reserved.
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