GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
NCT ID: NCT07228117
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
400 participants
INTERVENTIONAL
2026-02-02
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety Evaluation of MiniMed™ 780G System With DS5 CGM in Children
NCT06604871
Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)
NCT07227805
In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes
NCT05238142
Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes
NCT04617795
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal Challenges
NCT03848767
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1 - No meal bolus administration
Patients will be asked not to bolus for any of their meals while using the NMX8 pump.
MiniMed™ NMX8-AID System with DS5™
Patients will be provided with the NMX8 system with DS5 CGM.
Arm 2 - Meal bolus administration at all meals
Patients will be asked to bolus for all of their meals while using the NMX8 pump.
MiniMed™ NMX8-AID System with DS5™
Patients will be provided with the NMX8 system with DS5 CGM.
Arm 3 - Meal bolus administration at will
Patients are free to bolus or not bolus for their meals as they wish using NMX8 pump.
MiniMed™ NMX8-AID System with DS5™
Patients will be provided with the NMX8 system with DS5 CGM.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MiniMed™ NMX8-AID System with DS5™
Patients will be provided with the NMX8 system with DS5 CGM.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. T1D: Age 7-85 years
2. T2D: Age 18-85 years
2. Has a clinical diagnosis of diabetes for a minimum per diabetes type below:
1. T1D (Age 7-85 years): Diagnosis of T1D for at least 6 months, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
2. T2D (Age 18-85 years): Diagnosis of insulin-requiring T2D for 1 year or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Is willing to provide informed consent/assent for participation.
4. Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.
5. Is willing to wear the system continuously throughout the study.
6. Has a retinal eye examination prior to enrollment (if needed) per guidelines by the local professional society/hospital guidelines according to age, duration of diabetes and type of diabetes. Entry into the study is permitted at the investigators' discretion, depending on their interpretation of the findings.
7. Is willing to upload study pump data via an app or computer.
8. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:
1. Humalog™\* (insulin lispro injection)
2. NovoLog™\*/NovoRapid™\* (insulin aspart solution for injection)
3. Admelog™\* (insulin lispro injection)
4. Merilog™\* (insulin aspart)
5. Authorized generic insulin aspart
6. Authorized generic insulin lispro
Exclusion Criteria
2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:
1. Medical assistance (i.e., Paramedics, Emergency Room \[ER\] or Hospitalization)
2. Coma or
3. Seizures
3. Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.
4. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
5. Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
6. Currently pregnant or planning to become pregnant during the time period of study participation
1. A negative pregnancy test will be required for all females of child-bearing potential prior to enrollment
2. For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable
7. At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.
8. Has diagnosis of adrenal insufficiency.
9. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.
10. T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and/or Glucagon-like peptide-1 (GLP-1), in the 8 weeks prior to screening.
1. Participants who have stopped using metformin and/or GLP-1 have done so at least 6 weeks prior to screening.
2. Participants currently taking metformin and/or GLP-1 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study.
11. T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1, Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.
1. Participants who have stopped using metformin, GLP-1 or SLT-2 have done so at least 6 weeks prior to screening.
2. Participants currently taking metformin, GLP-1 or SGLT-2 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study
12. Is using sulfonylureas and meglitinides, e.g. repaglinide
13. Is using inhalable insulin in the 8 weeks prior to screening.
14. Is using hydroxyurea at time of screening or plans to use it during the study
15. Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study.
16. Is, at the discretion of the investigator, abusing drugs or alcohol.
17. Is, in the opinion of the investigator, not able to perform all study procedures safely.
18. Has a history of visual impairment which would not allow subject, even with the help of a caregiver, to participate in the study and perform all study procedures safely, as determined by the investigator.
19. Has elective surgery planned that requires general anesthesia during the course of the study.
20. Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
21. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
22. Is diagnosed with current eating disorder such as anorexia or bulimia.
23. Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c
24. Is on dialysis.
25. Has an estimated Glomerular Filtration Rate (eGFR) \<30.
26. Has celiac disease that is not adequately treated as determined by the investigator.
27. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
28. Has had any of the following cardiovascular events more than 1 year prior to screening and should not participate at the discretion of the investigator: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
29. Is a member of the research staff involved with the study.
30. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).
7 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Diabetes
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CIP351
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.