Clinical trialNCT07228117RecruitingInterventional

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

SponsorMedtronic MiniMed, Inc.Enrollment400Type 1 Diabetes MellitusType 2 Diabetes Mellitus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

38 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia

John Hunter Children'S Hospital
New Lambton, New South Wales, Australia
Bruce King
Recruiting
Royal North Shore Hospital
Sydney, New South Wales, Australia
Sarah Glastras
Recruiting
the Kids Research Institute Australia
Perth, Western Australia, Australia
Timothy Jones
Recruiting

New Zealand

University of Otago - Dunedin Hospital
Dunedin, New Zealand
Benjamin Wheeler
Recruiting

United States

Medical Investigations
Little Rock, Arkansas, United States
James Thrasher, M.D.
Recruiting
Headlands Research California, Llc
Escondido, California, United States
Chris Guerin, M.D.
Recruiting
Sansum Diabetes Research Institute
Goleta, California, United States
Kristin Castorino, D.O.
Recruiting
Loma Linda University Medical Center
Loma Linda, California, United States
Scott Lee, M.D.
Recruiting
Sutter Institute for Medical Research
Sacramento, California, United States
Gnanagurudasan Prakasam, M.D.
Recruiting
Rady Children'S Hospital - San Diego
San Diego, California, United States
Withdrawn
University of California San Francisco Ucsf the Madison Clinic for Pediatric Diabetes
San Francisco, California, United States
Laya Ekhlaspour, M.D.
Recruiting
Mills-Peninsula Medical Center: Diabetes Research Institute
San Mateo, California, United States
David Klonoff, M.D.
Recruiting
Stanford University Medical Center
Stanford, California, United States
Rayhan Lal, M.D.
Recruiting
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Gregory Forlenza, M.D.
Recruiting
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Halis Akturk, M.D.
Recruiting
Yale University School of Medicine
New Haven, Connecticut, United States
Jennifer Sherr, M.D.
Recruiting
Usf Diabetes and Endocrinology Center
Tampa, Florida, United States
Dorothy Shulman, M.D.
Recruiting
Metabolic Research Institute
West Palm Beach, Florida, United States
Barry Horowitz, M.D.
Recruiting
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Bruce Bode, M.D.
Recruiting
Emory University School of Medicine
Atlanta, Georgia, United States
Francisco Pasquel, M.D.
Recruiting
Endocrine Research Solutions
Roswell, Georgia, United States
John Reed, M.D.
Recruiting
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
David Liljenquist, M.D.
Recruiting
Northwestern University
Chicago, Illinois, United States
Grazia Aleppo-Kacmarek, M.D.
Recruiting
Indiana University Health Riley Hospital for Children
Indianapolis, Indiana, United States
Linda DiMeglio, M.D.
Recruiting
Iowa Diabetes and Endocrinology Center
West Des Moines, Iowa, United States
Anuj Bhargava, M.D.
Recruiting
Barry J. Reiner, Md Llc
Baltimore, Maryland, United States
Barry Reiner, M.D.
Recruiting
International Diabetes Center
Minneapolis, Minnesota, United States
Anders Carlson, M.D.
Recruiting
Bryan Physician Network
Lincoln, Nebraska, United States
Shannon Wakeley, M.D.
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Withdrawn
Nyc Research Inc
Long Island City, New York, United States
Anastasios Manessis, M.D.
Recruiting
Pardee Bluemd Endocrinology
Arden, North Carolina, United States
Withdrawn
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Withdrawn
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, United States
David Huffman, M.D.
Recruiting
Texas Diabetes & Endocrinology
Austin, Texas, United States
Luis Casaubon, M.D.
Recruiting
Revival Research Institute
Denton, Texas, United States
Seema Haq, M.D.
Recruiting
Tekton Research
McKinney, Texas, United States
Pablo Mora, M.D.
Recruiting
Rainier Clinical Research Center
Renton, Washington, United States
Frances Broyles, M.D.
Recruiting
Seattle Children'S
Seattle, Washington, United States
Catherine Pihoker, M.D.
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 Feb 2026
Primary completion: 31 Jan 2027
Completion: 31 Jan 2027
Last update posted: 11 Aug 2026
Registered enrollment: 400
Registry id: NCT07228117

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.