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First CGM with implanted glucose sensor for diabetic patients gets FDA nod

Patients with type 1 or type 2 diabetes now have a new option for monitoring their glucose levels following the US Food and Drug Administration’s (FDA) decision to approve the first continuous glucose monitoring (CGM) system with a fully implantable sensor. 

The Eversense CGM can be worn for up to 90 days, with patients able to obtain readings via their smartphones and compatible mobile medical apps. The sensor needs to be implanted by a qualified healthcare provider, who places it under the skin during an outpatient procedure. Measurements are sent to compatible mobile devices every five minutes, sending alerts to users if readings show signs of hyperglycemia (high glucose levels) or hypoglycemia (low glucose levels). 

Use of new products utilizing digital technology to improve patient care, such as the Eversense CGM, is an area the FDA is taking steps to advance, said FDA Commissioner Scott Gottlieb, MD. He assured consumers the agency is also taking measures to form a carefully tailored regulatory approach for software products to ensure these new technologies are properly overseen and to “maintain the FDA’s gold standard for product review”.

Highlighting the important role these devices and software could play in medicine and disease management, Gottlieb commented: “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.”

Diabetes affects more than 30 million people in the United States, with an estimated 7 million of these as yet undiagnosed, figures published in the Center for Disease Control and Prevention’s 2017 National Diabetes Statistics Report revealed. In 2016, around 224 million diabetes medications, such as Glucophage (metformin) or Humulin N (isophane insulin), were dispensed in the US, making it the seventh most dispensed form of medicine in the country, according to the IQVIA National Prescription Audit. 

The Eversense CGM was approved for use in patients with diabetes aged 18 years and over following the FDA’s evaluation of clinical study data from 125 individuals. The effectiveness of the device was reviewed by comparing readings obtained from the device with those from a laboratory-based glucose analyzer. 

Less than one percent of participants in the study experienced a serious adverse event, but potential adverse events related to insertion, removal or wear of the device include: allergic reactions to adhesives, bleeding, bruising, infection, pain, discomfort, scarring, skin discoloration, fracture of the sensor during removal, and discoloration, inflammation, redness or thinning of the skin.