these blog posts are written by Dr. alfredo G. Tomasselli, a Retired bio-Chemist and Bio-physicist who spent his life in Academia and The Pharmaceutical Industry researching cures and treatments for diseases such as HIV/Aids, Diabetes, and Rheumatoid arthritis. His daughter sara inspires this blog and helps to write posts. sara was diagnosed with type 1 diabetes on april 4th, 2014 at the age of 30. 

2016 The FDA approves the FreeStyle Libre ProTM System for healthcare professional CGM in patients with diabetes

This document is for informational purposes only and cannot be taken to make medical or other personal decisions

A continuous glucose monitoring system for use by healthcare professionals for their diabetic patients (for those 18 and older) has been approved by the FDA on September 28, 2016. The system, developed by Abbott, is named the FreeStyle Libre Pro SystemTM. How does it work? A filament is inserted in the interstitial fluid under the patient’s skin by a professional healthcare provider and a small round sensor placed in the back of the patient’s upper arm. The filament is connected to the sensor and kept under the skin for up to 14 days; which at this point would need to be replaced. No finger prick calibrations are needed. The sensor reads the glucose concentration every minute (it is not exactly a continuous reading, but close to it), plots the glucose concentration average every 15 minutes, and stores graphically the readings occurring over a span of eight hours. After 14 days, the patient returns to the doctor who employs a reader to scan the sensor and reads the results on a screen.  The doctor can determine the glucose trend over the previous 2-week period; specifically, how long the patient has stayed within glucose targeted range and how often the patient has gone above or below it. In this way the doctor would evaluate if therapy has worked and suggest therapy adjustment if needed.

The Abbott system is going to be available to US healthcare professionals within weeks. Go to link www.FreeStyleLibrePro.us and/or http://abbott.mediaroom.com/2016-09-28-Abbott-Receives-FDA-Approval-for-the-FreeStyle-Libre-Pro-System-a-Revolutionary-Diabetes-Sensing-Technology-for-Healthcare-Professionals-to-Use-with-Their-Patients for details about the FreeStyle LibreTM system.

The other important news is Abbott’s submission of the FreeStyle Libre TM system consumer version to the FDA for review. In a previous posting in this blog we reported that the FreeStyle LibreTM system consumer version was approved in Europe on September 2014 (May 10 2015 FreeStyle Libre Flash Glucose Monitoring System, already in use in Europe, http://www.steelimmunity.com/blog/2015/5/10/freestyle-libre-flash-glucose-monitoring-system-already-in-use-in-europe ). With this version of the CGM system, the patient can, on his/her own, both change the filament under the skin every 14 days and take readings any time he/she would like to. The system allows to take readings even when the sensor is covered by clothing and the reader holds up to 90 days of data. This procedure is simple and consists of swiping a reader over the sensor and in a second, both a real-time and an 8-hour glucose history are obtained. The patient knows immediately if his/her glucose is going up or down and he/she can also verify his/her blood glucose level history over the previous 90 days without the help of a healthcare professional. The system is easily wearable and the 14-day period of uninterrupted wearing without the need of finger prick calibration is a much longer time than that of any other systems presently on the market.

The FreeStyle LibreTM seems a significant step forward in continuous glucose monitoring and some European friends have made positive comments about their experience of using it in Europe.

Alfredo G.

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