t:slim X2 with Control-IQ+ technology - Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Intended purpose

The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. Control-IQ+ technology is intended for use with a compatible continuous glucose monitor (CGM) and the t:slim X2 insulin pump to automatically increase, decrease, and suspend delivery of basal insulin based on CGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold.