NCT05029271

InPen User Experience

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Diabetes Type 1

Interventions

Type	Name	Description
DEVICE	InPen with Guardian 4 System	Subjects will receive the InPen™ and InPen™ Diabetes Management App combined with the Guardian™ 4 system.

Timeline

• Start date: 2023-04-17
• Primary completion: 2023-12-08
• Completion: 2023-12-08
• First posted: 2021-08-31
• Last updated: 2024-01-10

Locations

3 sites across 1 country: Sweden