At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Use of the Guardian™ Connect System With Smart Connected Devices
In Brief
A clinical study evaluating Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app for Type 1 Diabetes Mellitus. Completed, enrolled 217 participants across 14 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.