Use of the Guardian™ Connect System With Smart Connected Devices

Summary

Participation Requirements

Description

The study is a multi-center, prospective single-arm design without controls. All subjects will participate for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older will participate for up to 9 months (Phase 2). All subjects will wear the Guardian Connect system (real-time contin...

The study is a multi-center, prospective single-arm design without controls. All subjects will participate for a minimum of 90 days (Phase 1) and some subjects 18 years of age or older will participate for up to 9 months (Phase 2). All subjects will wear the Guardian Connect system (real-time continuous glucose monitoring (CGM)) continuously and use smart insulin pens or insulin pens with smart caps for multiple daily injections and continue their standard therapy throughout the duration of the study. The subject's insulin delivery, sleep, physical activity (as applicable) and food intake data will be collected through applications with meal logging requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using Box and/or monthly menstrual cycle logging using Apple Health.

Tracking Information