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GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
Sponsor: Medtronic Diabetes
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.
Key Details
Gender
All
Age Range
7 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-02-02
Completion Date
2026-12
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
MiniMed™ 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