NCT07227805

Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)

Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system.

Detailed description

This study is a pre-market, interventional, prospective, open-label, multi-center and randomized controlled clinical study. The study consists of a run-in phase and a study phase. Run-in Phase: The purpose of the run-in phase is to collect baseline CGM data while subjects are on 780G therapy in Auto Mode. All subjects will use the Simplera Sync sensor. At the end of the run-in phase, subjects will be randomly allocated to one of the two study arms (Treatment arm or Control arm). Study Phase: During the 12-week study phase, subjects will either start using the MiniMed™ NMX8 system (Treatment arm) or will continue to use the MiniMed™ 780G in Auto Mode (Control arm). During the study phase, all subjects will use the Simplera™ Sync sensor.

Conditions

• Diabetes (Insulin-requiring, Type 1 or Type 2)

Interventions

Type	Name	Description
DEVICE	NMX8	Subjects will start using the MiniMed™ NMX8 system for 12 weeks
DEVICE	780G	Subjects will continue to use the MiniMed™ 780G for 12 weeks

Timeline

• Start date: 2026-06-15
• Primary completion: 2027-03-17
• Completion: 2027-03-17
• First posted: 2025-11-13
• Last updated: 2025-11-13

Regulatory

• FDA-regulated device study