FDA approves first continuous glucose monitoring system
pharmafile | June 22, 2018 | News story | Medical Communications, Sales and Marketing | FDA, diabetes, pharma
The US Food and Drug Administration (FDA) has approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people aged over 18 with diabetes.
This system will include a fully implantable sensor to detect glucose; the Eversense CGM system uses a small sensor that is implanted just under the skin. After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days.
The implanted sensor works with a novel light-based technology to measure glucose levels and send information to a mobile app to alert users if glucose levels are too high (hyperglycemia) or too low (hypoglycemia).
People with diabetes either do not make enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes). When the body does not have enough insulin, or cannot use it effectively, 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.
Individuals living with diabetes must regularly monitor their glucose levels as part of the management of the disease, including making sure that diabetes management accessories are replaced on a regular basis.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said FDA Commissioner Scott Gottlieb. “These technologies allow patients to gain better control over their health. This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms. The FDA is creating a new and more carefully tailored regulatory approach for software products, including mobile medical apps, that will enable efficient oversight of these digital technologies and maintain FDA’s gold standard for product review.”
The FDA evaluated clinical study data from 125 individuals aged 18 and older with diabetes and reviewed the device’s effectiveness by comparing readings obtained by the Eversense CGM system to those obtained by a laboratory-based glucose analyser.
The safety of the Eversense CGM system’s 90-day implantable sensor, and the procedure used to implant it, was also evaluated during the clinical studies.
Jason Holmes
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