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

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/Simplera Sync 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. Participants will use their current therapy while also wearing the DS5/Simplera sensor for up to 40 days. During this time, they will complete a meal and exercise log. Participants will then be placed into one of three groups by chance and given the NMX8 pump to use for about 90 days. During this time, participants will bolus, not bolus, or bolus at will 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 participants 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.

NCT Number	NCT07228117
Lead Sponsor	Medtronic MiniMed, Inc.
Conditions	Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Enrollment	400 participants
Start Date	2026-02-02
Primary Completion	2027-01 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-11