Absolutely! Yeah, NICE-SUGAR definitely has its flaws, the main one being that it has a lot more hypoglycemia than it should - a combination of the open loop protocol, infrequent sample time, no patient model, and static dosing protocol with only rescue bolusing. We did a series of simulation studies a few years ago comparing various state of the art ICU controllers, and while NICE-SUGAR has excellent time in range, it has poor performance in the hypo range, which has been linked to increased mortality.
The key is to get low variability and lots of time in range, but absolutely no hypoglycemia of any kind. That's what it's going to take to crack this problem. We hope our second human trial will continue to show those characteristics, and in a few years, an RCT pivotal trial.
The key is to get low variability and lots of time in range, but absolutely no hypoglycemia of any kind. That's what it's going to take to crack this problem. We hope our second human trial will continue to show those characteristics, and in a few years, an RCT pivotal trial.
Here's the NICE-SUGAR protocol for your reference: https://studies.thegeorgeinstitute.org/nice/docs/ALGORITHM.p...