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 First Artificial Pancreas Automatic Insulin Delivery for people with T1D Has been Approved by the FDA

In a previous narrative, July 20 2016 Closing the loop: the “Artificial Pancreas” is approaching approval for use in Type 1 Diabetes people we highlighted the development of the so-called Artificial Pancreas. http://www.steelimmunity.com/blog/2016/7/20/july-20-2016-closing-the-loop-the-artificial-pancreas-is-approaching-approval-for-use-in-type-1-diabetes-people In particular, we emphasized the technical aspects of the MiniMed 670G system developed by Medtronic, a medical devices company. At the time, MiniMed 670G had completed clinical trials involving 124 T1D patients and the results were submitted for evaluation by the Food and Drug Administration (FDA). These patients were already managing their diabetes reasonably well, and improving it by the use of this system was an important accomplishment. It is remarkable that more than 100 participants requested to continue using MiniMed 670G, a fact that underlines a favorable opinion among a high percentage of participants. It is not surprising therefore that on September 28, 2016, the FDA approved the Medtronic system for use in people with type 1 diabetes.

This system is not yet completely automatic as it still requires some manual operation to control blood glucose properly. Moreover, it delivers basal insulin only, and is approved for people who are 14 years old or older. Obviously, these are limitations, as the patient still needs to count carbohydrates and give himself/herself meal boluses of insulin. However, the approval of this device is an important advancement in the present treatment of T1D and paves the way for future systems that will hopefully be capable of automatic delivery of  meal boluses of insulin in response to raising glucose with minimal or no intervention from the patient. 

It is estimated that the MiniMed 670G will be on the market in the Spring of 2017. The letter of approval can be found at the link http://www.accessdata.fda.gov/cdrh_docs/pdf16/P160017a.pdf

 

 

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

2016 Closing the loop: the “Artificial Pancreas” is approaching approval for use in Type 1 Diabetes people