NCT07401901

Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system (referred also to as NMX8 system), in comparison with other commercially available AID systems (Automated insulin delivery) in adult patients with Type 1 diabetes not achieving target clinical outcomes.

Detailed description

ELEVATE is a pre-market, interventional, prospective, open-label, multi-center, randomized controlled study that consists of three phases: run-in, study and continuation phase. Run-in: the purpose of this phase is to collect 3 weeks of blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current therapy (baseline assessment). All subjects will use an additional blinded Simplera Sensor to collect blinded CGM data. Study Phase: during the 6-month of study phase subjects will either start using the NMX8 system (Treatment arm) or will continue to use their current AID therapy (Control arm). Subjects in the Control arm will undergo 3 weeks of blinded CGM data collection via Simplera Sensor at 3 and 6 months. Continuation Phase: during the 3-month of continuation phase all subjects will use the NMX8 system. Approximately 230 subjects will be enrolled in the study up to approximately 22 investigational centers in EMEA.

Conditions

• Type 1 Diabetes (T1D)

Interventions

Type	Name	Description
DEVICE	NMX8 System - Treatment arm	Subjects start using the NMX8 system after the run-in phase and continue through both study (6-month) and continuation phases (3-month).
DEVICE	AID Therapy	Subjects will continue to use their current AID therapy during the study phase (6-month).
DEVICE	NMX8 System - Control Arm	Subjects start using the NMX8 system during the continuation phases (3-month).

Timeline

• Start date: 2026-07-15
• Primary completion: 2027-11-04
• Completion: 2028-02-28
• First posted: 2026-02-11
• Last updated: 2026-02-12

Locations

20 sites across 6 countries: France, Germany, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated device study