Use of the Guardian™ Connect System With Smart Connected Devices
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Device: Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
- Registration Number
- NCT04809285
- Lead Sponsor
- Medtronic Diabetes
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Guardian™ Connect system, InPen™ Basal smart cap, and smart insulin pens Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app 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.
- Primary Outcome Measures
Name Time Method Percentage of Time in Hypoglycemia 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 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 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Arkansas Diabetes and Endocrinology Center
🇺🇸Little Rock, Arkansas, United States
Mary and Dick Allen Diabetes Center
🇺🇸Newport Beach, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Salinas Valley Memorial Healthcare System
🇺🇸Salinas, California, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸Aurora, Colorado, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Endocrine Research Solutions, Inc.
🇺🇸Roswell, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center
🇺🇸Idaho Falls, Idaho, United States
Rhode Island Hospital (Lifespan Clinical Research Center)
🇺🇸Providence, Rhode Island, United States
AM Diabetes and Endocrinology Center
🇺🇸Bartlett, Tennessee, United States
Texas Diabetes and Endocrinology
🇺🇸Round Rock, Texas, United States
Rainer Clinical Research Center
🇺🇸Renton, Washington, United States
Endocrine and Metabolic Consultants
🇺🇸Rockville, Maryland, United States