Subcutaneous glucose sensor

Intended purpose

The sensor is a component of Medtronic continuous glucose monitoring (CGM) systems and is indicated for continuously monitoring glucose levels in persons with type 1 diabetes. The sensor is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. For the use with MiniMed 780G insulin pump, when the SmartGuard feature is active, SG readings are used to calculate basal insulin delivery and correction boluses. The sensor is indicated for the following patients: Ages 2 or older with type 1 diabetes when used as part of a system with Guardian Connect; Ages 2 or older with type 1 diabetes when used as a part of a system with the MiniMed 640G insulin pump; Ages 7 or older with type 1 diabetes when used as part of a system with the MiniMed 670G or MiniMed 770G insulin pump; Ages 7-80 with type 1 diabetes when used as part of a system with the MiniMed 780G insulin pump. The indication for children under the age of 18 is limited to those who are supervised by a caregiver. The caregiver must be at least 18 years of age.