Control-IQ+ technology

Control-IQ+ technology is a software-only automated insulin delivery system that controls insulin delivery from a compatible insulin pump based on continuous glucose monitor readings and user inputs. It is intended for managing Type 1 diabetes in persons 2 years and older, and Type 2 diabetes in persons 18 years and older, operating in three modes (Normal, Sleep, Exercise) with different glucose target ranges.

Control-IQ+ adds compatibility with Lyumjev U-100 insulin in addition to the predicate's NovoLog and Humalog insulins. All other technical characteristics including pump type, basal rate ranges, correction bolus limits, body weight settings, and temporary basal rate functionality remain identical to the predicate device K243823.

Not stated in this summary.

The device has identical indications for use, classification, and product code as the predicate. The only substantive difference is the addition of Lyumjev as a compatible insulin, which was validated through a pivotal clinical trial (TL1) demonstrating that Lyumjev use with Control-IQ technology resulted in safety and effectiveness comparable to or better than the predicate, with severe hypoglycemia and DKA rates lower than reference registry data. Since the algorithm, operating parameters, and system architecture remain unchanged and the new insulin compatibility has been clinically validated, the device is substantially equivalent.