Diabetics, this is the start of something big! The first product approved by the U.S. Food and Drug Administration (FDA) that require very few fingersticks to monitor your blood glucose is available! The FDA recently expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System1 .
Here’s what the FDA2 said:
“The FDA works hard to help ensure that novel technologies, which can reduce the burden of daily disease management, are safe and accurate,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “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 and may encourage them to have a 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 multiple times per day by taking a blood sample from the fingertip (known as a “fingerstick” sample) and testing it with a blood glucose meter. Results indicate if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), helping patients and their health care providers make appropriate diabetes management decisions.
The G5 Mobile Continuous Glucose Monitoring System uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels. Real-time results are sent wirelessly every five minutes to a dedicated receiver and a compatible mobile device (e.g., smartphone or tablet) running a mobile app. Alarms and alerts indicate glucose levels above or below user-set thresholds. The system measures glucose in the fluid under the skin and must be calibrated at least two times per day using blood obtained from fingerstick tests. However, additional daily fingerstick blood tests are generally no longer necessary because unlike other continuous glucose monitoring systems, results from this device can now be used directly by patients to make diabetes treatment decisions without confirmation from a traditional fingerstick test.
According to the U.S. Centers for Disease Control and Prevention, more than 29 million people in the U.S. have diabetes. People with diabetes either don’t make enough insulin (type 1 diabetes) or can’t use insulin properly (type 2 diabetes). When the body doesn’t have enough insulin or can’t use it effectively, blood sugar builds up in the blood. High blood sugar levels can lead to heart disease; stroke; blindness; kidney failure; and amputation of toes, feet or legs.
The FDA evaluated data from two clinical studies of the G5 Mobile Continuous Glucose Monitoring System. These studies included 130 adults and children aged two years and older with diabetes. All studies included a seven-day period where system readings were compared to blood glucose meter values, as well as to a laboratory test method that measures glucose values. No serious adverse events were reported during the studies.
Risks associated with the use of the system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate and used to make treatment decisions or where hardware or set-up issues disable alarms and alerts, as well as skin irritation or redness around the device’s adhesive patch. Users are warned that the system must be calibrated using a fingerstick blood sample at least once every 12 hours and that taking any medications containing acetaminophen while wearing the system may falsely raise glucose readings.
The G5 Mobile Continuous Glucose Monitoring System is manufactured by Dexcom, Inc., located in San Diego, California. Click on this link to watch the 3-minute video.
The FDA release this information on December 20, 2016.
Why is this new glucose monitoring system so important? Because Diabetes is the 6th leading cause of death among Black Americans(3). 13.2% of all African Americans aged 20 years or older have diagnosed diabetes(4).
Jay Harold has written several posts about diabetes in 2016, including:
- Fighting for Your Health: Diabetes’ Deadly Impact on Minorities
- 4 Surprising Facts About Diabetes: Read This!
- Managing Diabetes in the Heat: 8 Summer Tips
Jay Harold would like to wish you better health and wealth this Holiday season. Please take this advice of Muhammad Ali and give back to others. “Service to others is the rent you pay for your room here on earth.” ~ Muhammad Ali
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