Actively Recruiting
GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
Led by Medtronic MiniMed, Inc. · Updated on 2026-05-13
400
Participants Needed
36
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Patients 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. 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
Official Title
GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 7-85 years for Type 1 diabetes; age 18-85 years for Type 2 diabetes
- Clinical diagnosis of diabetes for at least 6 months for Type 1 or at least 1 year of insulin-requiring Type 2 diabetes
- Willing to provide informed consent or assent
- Able to read English or Spanish study materials
- Willing to wear the system continuously during the study
- Has a retinal eye exam on record according to specific age, diabetes type, and duration guidelines
- Willing to upload pump data via app or computer
- Willing to use one of the specified insulin types and financially support insulin use as required by the study
You will not qualify if you...
- Unable to consent due to mental or intellectual disability
- History of 2 or more severe hypoglycemia episodes requiring medical assistance, coma, or seizures in past 6 months
- History of 1 or more diabetic ketoacidosis episodes in past 6 months
- For Type 2 diabetes, history of hyperglycemic hyperosmolar syndrome in past 6 months
- Unresolved skin conditions at sensor or infusion sites
- Currently pregnant or planning pregnancy during the study
- Untreated or inadequately treated thyroid disorders
- Diagnosis of adrenal insufficiency
- Use of glucocorticoids within 8 weeks prior to screening
- Use of non-insulin diabetes medications other than specified exceptions within 8 weeks prior to screening
- Use of sulfonylureas, meglitinides, or inhalable insulin within 8 weeks prior to screening
- Use or planned use of hydroxyurea during the study
- Participation in another clinical trial within 2 weeks prior to enrollment or during the study
- Substance abuse or inability to safely perform study procedures
- Visual impairment preventing safe participation
- Planned elective surgery requiring general anesthesia during the study
- Sickle cell disease, recent blood transfusions or erythropoietin use
- Current eating disorder diagnosis
- Recent blood disorders that interfere with HbA1c measurement
- On dialysis or with low kidney function (eGFR <30)
- Untreated celiac disease
- Recent or significant cardiovascular events
- Research staff or Medtronic Diabetes employees and their immediate family (excluding adult children/siblings)
AI-Screening
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Trial Site Locations
Total: 36 locations
1
Medical Investigations
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
Headlands Research California, LLC
Escondido, California, United States, 92025
Actively Recruiting
3
Sansum Diabetes Research Institute
Goleta, California, United States, 93111
Actively Recruiting
4
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
5
Sutter Institute for Medical Research
Sacramento, California, United States, 95821
Actively Recruiting
6
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
7
University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes
San Francisco, California, United States, 94158
Actively Recruiting
8
Mills-Peninsula Medical Center: Diabetes Research Institute
San Mateo, California, United States, 94401
Actively Recruiting
9
Stanford University Medical Center
Stanford, California, United States, 94304
Actively Recruiting
10
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Actively Recruiting
11
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Actively Recruiting
12
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Actively Recruiting
13
USF Diabetes and Endocrinology Center
Tampa, Florida, United States, 33612
Actively Recruiting
14
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
Not Yet Recruiting
15
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
Actively Recruiting
16
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318
Actively Recruiting
17
Endocrine Research Solutions
Roswell, Georgia, United States, 30076
Actively Recruiting
18
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
19
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
20
Indiana University Health Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
21
Iowa Diabetes and Endocrinology Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
22
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
Actively Recruiting
23
Bryan Physician Network
Lincoln, Nebraska, United States, 68510
Actively Recruiting
24
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
25
NYC Research Inc
Long Island City, New York, United States, 11106
Actively Recruiting
26
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
27
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, United States, 37411
Not Yet Recruiting
28
Texas Diabetes & Endocrinology
Austin, Texas, United States, 78731
Not Yet Recruiting
29
Revival Research Institute
Denton, Texas, United States, 76210
Actively Recruiting
30
Tekton Research
McKinney, Texas, United States, 75069
Actively Recruiting
31
Rainier Clinical Research Center
Renton, Washington, United States, 98057
Actively Recruiting
32
Seattle Children's
Seattle, Washington, United States, 98105
Actively Recruiting
33
John Hunter Children's Hospital
New Lambton, New South Wales, Australia, 2305
Actively Recruiting
34
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Actively Recruiting
35
The Kids Research Institute Australia
Perth, Western Australia, Australia, 6009
Actively Recruiting
36
University of Otago - Dunedin Hospital
Dunedin, New Zealand, 9016
Actively Recruiting
Research Team
S
Shannon Bondy
CONTACT
T
Thomas Troub
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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