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Clinical Trial Summary

The purpose of this study is to evaluate the user experience of InPen™ with InPen™ Diabetes Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of a future pivotal study.

Clinical Trial Description

This study is a multi-center, single arm study in insulin-requiring adult subjects with type 1 diabetes treated with MDI (basal and bolus) therapy. The total study duration will be approximately 10 weeks long for each participant. The study consists of a run-in (phase 1) and study phases 2, 3 and 4. Phase 1: The purpose of the run-in phase is to collect baseline HbA1c and blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current MDI therapy. Phase 2: All subjects will utilize a smart bolus insulin pen injector (InPen™) and app with dose calculator (InPen™ Diabetes Management App), and will continue their own SMBG, iscCGM or RT-CGM for two weeks. Phase 3: Subjects will continue on the InPen and InPen App for another two weeks utilizing the HCP insights gained during the titration follow-up visit. Phase 4: All subjects will utilize the InPen™ system consisting of: - InPen™ and InPen™ Diabetes Management App - Guardian™ 4 system (RT-CGM) - Guardian™ 4 sensor - Guardian™ 4 transmitter - Guardian™ 4 app ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05029271
Study type Interventional
Source Medtronic Diabetes
Contact Fabiona Hoevelaken
Phone +31 (0)6 115 978 31
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date March 2022

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