RecruitingNot ApplicableNCT07228117

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


Sponsor

Medtronic MiniMed, Inc.

Enrollment

400 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 7 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety of the MiniMed NMX8 automated insulin delivery (AID) system — a next-generation closed-loop insulin pump that automatically adjusts insulin doses — in people with type 1 or insulin-requiring type 2 diabetes. **You may be eligible if...** - You have type 1 diabetes (age 7-85) or insulin-requiring type 2 diabetes (age 18-85) - You have had diabetes for at least 6 months (type 1) or at least 1 year (type 2) - You are willing to wear the device continuously and upload data - You can read English or Spanish - You can financially support the required insulin types (Humalog, NovoLog, or similar) **You may NOT be eligible if...** - You do not have diabetes or your diabetes does not require insulin - You are not willing or able to wear or use the device as required - You cannot attend the required study visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMiniMed™ NMX8-AID System with DS5™

Patients will be provided with the NMX8 system with DS5 CGM.


Locations(33)

Medical Investigations

Little Rock, Arkansas, United States

Headlands Research California, LLC

Escondido, California, United States

Sansum Diabetes Research Institute

Goleta, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Sutter Institute for Medical Research

Sacramento, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes

San Francisco, California, United States

Mills-Peninsula Medical Center: Diabetes Research Institute

San Mateo, California, United States

Stanford University Medical Center

Stanford, California, United States

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Yale University School of Medicine

New Haven, Connecticut, United States

USF Diabetes and Endocrinology Center

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Endocrine Research Solutions

Roswell, Georgia, United States

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Northwestern University

Chicago, Illinois, United States

Indiana University Health Riley Hospital for Children

Indianapolis, Indiana, United States

Iowa Diabetes and Endocrinology Center

West Des Moines, Iowa, United States

International Diabetes Center

Minneapolis, Minnesota, United States

Bryan Physician Network

Lincoln, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

NYC Research Inc

Long Island City, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Revival Research Institute

Denton, Texas, United States

Tekton Research

McKinney, Texas, United States

Rainier Clinical Research Center

Renton, Washington, United States

Seattle Children's

Seattle, Washington, United States

John Hunter Children's Hospital

New Lambton, New South Wales, Australia

Royal North Shore Hospital

Sydney, New South Wales, Australia

The Kids Research Institute Australia

Perth, Western Australia, Australia

University of Otago - Dunedin Hospital

Dunedin, New Zealand

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NCT07228117


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