Use of the Guardian™ Connect System With Smart Connected Devices
The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin injection video capture and/or menstrual cycle tracking and/or cardiac monitoring in subjects with insulin requiring diabetes 2-80 years of age.
• Individual is 2-80 years of age at time of consent.
• A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator for:
⁃ at least the last 6 months for subjects 2-6 years of age
• Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing and can afford to use insulin pen(s) and pen cartridge(s).
• Subject is currently using or is willing to use the Guardian Connect system during the study.
• Subject agrees to comply with the study protocol requirements.
• For adult subjects: Subject is capable of providing legal consent without a legal authorized representative.