Indications for use in Canada

myLoop consists of the YpsoPump insulin pump, the CamAPS FX application and a compatible continuous glucose monitoring (CGM) system or sensor.

The YpsoPump system is intended for the subcutaneous delivery of insulin for the treatment of insulin-dependent diabetes mellitus. It is indicated for use with compatible rapid-acting insulin at a concentration of 100 U/mL in individuals who require a total daily insulin dose of at least 8 U/day.

CamAPS FX is a mobile app intended for managing glucose levels in people with type 1 diabetes including type 1 diabetes pregnancy, aged 2 years and over, using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals).

CamAPS FX requires a smartphone, and insulin pump and a continuous glucose monitor (CGM) to fulfil its intended use. CamAPS FX is compatible with YpsoPump (Ypsomed, Switzerland), Dexcom G6 (Dexcom, USA) and FreeStyle Libre 3 Plus sensor (Abbott Diabetes Care, UK).

CamAPS FX should only be used during pregnancy if the linked CGM Canadian labelling is explicitly labelled for use in pregnant women. Refer to the compatible CGM labelling to determine if the CGM can be used during pregnancy.