NCT04809285

Use of the Guardian™ Connect System With Smart Connected Devices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 2 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app	Guardian™ Connect system consists of Guardian™ Connect app, Guardian™ Connect transmitter, and Guardian Sensor (3), will be working with InPen™ Basal smart cap and smart insulin pens and InPen™ Diabetes Management app for multiple daily injections. 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.

Timeline

• Start date: 2021-04-06
• Primary completion: 2023-09-29
• Completion: 2023-09-29
• First posted: 2021-03-22
• Last updated: 2024-12-10
• Results posted: 2024-12-10

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study