FDA Approves First Continuous Glucose Monitoring System Not Requiring Blood Sample Calibration

The FDA approved last July the first continuous glucose monitoring system that could free millions of people with diabetes from daily finger sticks.

The Free Libre 14 Day Flash Glucose Monitoring System developed by Abbott uses a small sensor attached to the upper arm. The sensor has a small flexible metal wire that goes just below the skin where it generates a small electrical signal in response to the amount of sugar that is present in fluid under the skin (interstitial glucose).

This electrical signal is converted into a blood glucose reading, and is transmitted to a dedicated, mobile device (reader) when a user scans the reader near the sensor. The system does not require calibration with fingertip blood samples using a blood glucose meter. It has been approved for adult patients for use in helping to make treatment decisions. It detects both hyperglycemia and hypoglycemia to help patients make short-term and long-term treatment adjustments.

The FDA evaluated data from a clinical study of individuals aged 18 and older with diabetes, and reviewed the device’s performance by comparing readings obtained by the FreeStyle Libre Glucose Monitoring System to those obtained by an established laboratory method used for analysis of blood glucose.

When launched in the US, the FreeStyle Libre system did not have smartphone connectivity, but it would seem to be only a matter of time, since the company already offers data sharing via its LibreLinkup available in several other countries.

The convenience and ability to check blood sugar anytime are huge advantages over traditional glucose monitoring systems, but it comes at a price. The cost of one 10-day sensor ranges from $35 to $53 according to diaTribe Learn, a diabetes education website. That works out to about $108 to $160 per month for the supplies with an additional one-time cost of $69 to $97 for the reader.

At this time, US insurers, Medicare, and Medicaid do not yet cover the cost of the system, which means it would be all out-of-pocket for many people with diabetes until coverage can be negotiated with insurers. Until then, it could be a hefty monthly cost of as much as $160 compared to a typical $15 to $25 copay for many people using traditional monitoring systems.

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Sources: FDA press release and diatribe Learn

 

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