FDA Approves The First Automated Insulin System For Type 1 Diabetes
The Food and Drug Administration's approval of a new insulin delivery system for people with Type 1 diabetes is a big deal.
With Type 1 diabetes, the pancreas makes little or no insulin so people have to replace it with either multiple daily injections or a pump. In either case, that process involves constant error-prone adjustments, particularly around food and exercise. Over the long term, high blood sugar levels can lead to organ damage, but over-correcting by giving more insulin can cause dangerous low blood sugars that can lead to unconsciousness.
The device, Medtronic's MiniMed 670G hybrid closed loop system, is made up of an insulin pump and continuous glucose monitor (CGM), both of which are already on the market separately. The new part involves the communication between the two devices.
Medtronic's previous system already had a feature that would shut down the insulin pump if the wearer's blood sugar dropped too low. But the 670G predicts when a person's blood sugar is dropping and prevents the low in the first place, and also corrects high blood sugars.
This is the first such machine in the world with that level of automation, and thus it is informally being called the first "artificial pancreas" system.
However, it's called a hybrid rather than a fully closed-loop system because users will still need to signal that they're about to eat and estimate the carbohydrate count of the food so the device can calculate the additional amount of insulin needed. That means there's still the possibility of mistakes. But now if that count is off, the 670G will correct the err Continue reading