Abbott gets premarket approval from FDA for FreeStyle Libre Pro

///Abbott gets premarket approval from FDA for FreeStyle Libre Pro
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Abbott gets premarket approval from FDA for FreeStyle Libre Pro

By Lisa Foster-McNulty, MSN, RN, CDE

Folks with diabetes in the USA may or may not be aware that in other parts of the world, people with diabetes are using the Abbott Libre.  It’s a form of CGM (Continuous Glucose Monitoring) that doesn’t provide alarms for out of range blood glucose (BG) levels, but it also doesn’t need to be calibrated in order to track BG levels, and a sensor is worn for two weeks. 

In late September of 2016, Abbott announced that it secured premarket approval from the FDA for the FreeStyle Libre Pro continuous glucose monitoring system, which is designed to be used by healthcare professionals in treating diabetes patients.  This professional use device entails a patient-worn sensor, and it tracks glucose levels for up to 14 days.  A healthcare professional applies it to the back of a patient’s arm, and the device measures the glucose in interstitial fluid every 15 minutes by way of a thin filament which is inserted just under the skin.  For clinicians, it’s challenging to obtain complete and dependable glucose data on patients, and this technology provides a solution.  Healthcare providers will be able to wirelessly download data from the FreeStyle Libre Pro Flash in their office in approximately five seconds, according to Abbott.  This represents the second system in Abbott’s Flash glucose monitoring line, as a Freestyle Libre for personal use launched in Europe last fall. 

Since fingerstick calibration is not needed, patients don’t have to interact with the device while it is in use.  Glucose readings are recorded every 15 minutes, so up to 1,340 glucose values can be obtained over the 14 day monitoring period.  Healthcare providers get a detailed report, which is essentially an ambulatory glucose profile.  This can really assist them in making informed decisions about patient care. 

CGM systems for professional use have historically been considered to be expensive, cumbersome, and mostly for patients with Type 1 diabetes.  The FreeStyle Libre Pro system could be a game-changer because it is affordable, easy to use, and doesn’t require fingerstick calibration. 

Because this is a “blinded” professional system, we likely wouldn’t use this with our patients at Integrated Diabetes Services.  However, could this be an indication that approval of the Libre personal system might be on the way?  We’ll have to wait and see, but it looks like that’s a future possibility.

By | 2016-12-08T23:26:33+00:00 November 14th, 2016|November 2016 Newsletter|0 Comments

About the Author:

Integrated Diabetes Services is the worldwide leader in one-on-one consulting for people who use insulin. Diabetes “coaching” services are available in-person and remotely via phone and the internet for children and adults.

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