NCT07228117

GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 7 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor called Disposable Sensor 5 in people with diabetes. The study will include people with Type 1 diabetes who are 7-85 years old and people with Type 2 diabetes who are 18-85 years old. Patients will use their current therapy while also wearing the DS5 for up to 40 days. During this time, they will complete a meal and exercise log. Patients will then be put into one of three groups by a computer by chance and given the NMX8 pump to use for 90 days. During this time, patients will either bolus or not bolus for meals and continue to complete a meal and exercise log depending on the group they are in. Once their part in the study is over, if patients like the pump and want to keep using it, they may be able to join a Continued Access Period to keep using the NMX8 pump.

Conditions

• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	MiniMed™ NMX8-AID System with DS5™	Patients will be provided with the NMX8 system with DS5 CGM.

Timeline

• Start date: 2026-02-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-11-14
• Last updated: 2026-02-11

Locations

33 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated device study