Use of the Guardian™ Connect System With Smart Connected Devices
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- Medtronic Diabetes
- Enrollment
- 217
- Locations
- 13
- Primary Endpoint
- Percentage of Time in Hypoglycemia
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed 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 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), food intake data, and medication (as applicable) will be collected through applications with meal logging and medication requiring manual entry. In addition, subjects may also participate in optional self-administered insulin injection video capture and upload using a secure cloud-based site and/or monthly menstrual cycle logging using Apple Health and/or cardiac monitoring using BodyGuardian MINI.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Time in Hypoglycemia
Time Frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in hypoglycemia (SG \< 70 mg/dL)
Percentage of Time in Euglycemia
Time Frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in euglycemia (SG 70-180 mg/dL)
Percentage of Time in Hyperglycemia
Time Frame: Day 1 to Day 90 in Phase 1 and Day 91 to up to 9 months in Phase 2
The overall mean percentage of time in hyperglycemia (SG \> 180 mg/dL)