It was a big news day yesterday for FDA approval of diabetes devices.
The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.
Read yesterday’s full news release here.
I’m excited about this announcement for two reasons. First, this approval was received about six months before it was expected. I’m used to news coming later than predictions, not sooner. This is at least the second time the FDA has impressed me. The first time is when it approved the DexCom Share Receiver much sooner than expected. I’m optimistic that this is indicative of a great trend with the FDA.
Secondly, it’s another great step closer to a fully closed loop artificial pancreas system.
The 670G is a hybrid closed loop system. It will monitor glucose levels and adjust basal insulin to keep blood sugar as close to 120 as possible. Using this pump will still require carb counting, manually initiating meal boluses and corrections, and manually adjusting basal insulin to compensate for activity. This system is mono-hormonal: it uses only insulin, no glucagon. To me, the greatest benefit of this system may be for managing overnight basals.
For more information about this exciting announcement, here are some articles I found useful:
Updated 10/1/2016 to include this link to Diabetes Mine article describing what this pump is and what it is not. NEWSFLASH: FDA Approves First-Ever Pre-Artificial Pancreas from Medtronic!
diaTribe: Abbott’s FreeStyle Libre Pro AND Medtronic’s MiniMed 670G Get FDA Approval
diaTribe: Medtronic MiniMed 670G Trial Results: 44% Reduction in Hypoglycemia, 0.5% A1c Improvement
A Sweet Life: How the Medtronic 670G Artificial Pancreas Works: FAQ
Heath Day: FDA Approves 1st ‘Artificial Pancreas’ for Type 1 Diabetes
and also a lively discussion over at TuDiabetes.
This is Caleb... 
Thanks for your explanation, Lorraine. I’ve been wondering what exactly this system does — and doesn’t do. Your summary helped! I’m wondering if someone was running high would the pump automatically increase basal rates or is this just a protection against lows. (Which isn’t “just” really.) That is a remarkably quick approval! Wow!
It was a little overwhelming, yesterday, wasn’t it? Basal will be increased with rising blood sugars to protect against highs. The diaTribe “Trial Results” article I list in the post does a good job of explaining this.
I’ll check it out. Thanks!
I’m equally impressed with the FDA turnover on this… in just 103 or so days. With all they’ve done on the Dexcom approval fronts, and encouraged patient voices be included in the process, the device side of the FDA has come a long way from where it was 4-5 years ago. Thanks for sharing this.
Thanks for reading and commenting, Mike!