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

Recruiting now · Not applicable

Conditions studied: Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT07228117

Run by

Medtronic MiniMed, Inc.

People needed

400

Starts

2026-02-02

Expected to finish

2027-01-01

Last updated by the study team

2026-07-16

Who can join

Age: 7 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age at time of screening according to diabetes type:
• T1D: Age 7-85 years
• T2D: Age 18-85 years
• Has a clinical diagnosis of diabetes for a minimum per diabetes type below:
• 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.
• 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
• Is willing to provide informed consent/assent for participation.
• Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.
• Is willing to wear the system continuously throughout the study.
• Has results of a retinal eye examination on record prior to enrollment, per guidelines by the American Diabetes Association according to age, duration of diabetes and type of diabetes:
• T1D adults (Age 18-85 years):
• I. Initial retinal eye exam within 5 years of diagnosis. II. If the duration of type 1 diabetes is longer than 5 years, a retinal examination should have been performed within the last 12-18 months.
• T2D adults (Age 18-85 years):
• I. Results of a retinal eye exam, performed within the last 12-18 months, should be on record.
• T1D pediatric (Age 7-17 years):
• I. No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years.
• II. For children over the age of 10, a retinal exam should have been performed within 24 months of enrollment in the study.
• Per the investigator's discretion: If a potential participant is deemed to be at high risk, a retinal eye exam, performed within the last 12 months prior to screening, should be on record.
• Is willing to upload study pump data via an app or computer.
• Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:
• Humalog™* (insulin lispro injection)
• NovoLog™* (insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™*)
• NovoRapid™* (insulin aspart solution for injection)
• Admelog™* (insulin lispro injection)
• Merilog™* (insulin aspart)

You may not qualify if…

• Unable to consent due to a mental or intellectual disability.
• Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:
• Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)
• Coma or
• Seizures
• Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.
• T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
• Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Currently pregnant or planning to become pregnant during the time period of study participation
• A negative pregnancy test will be required for all females of child-bearing potential at time of screening
• 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
• At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.
• Has diagnosis of adrenal insufficiency.
• Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.
• T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and/or Glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) containing medications (e.g., Mounjaro), in the 8 weeks prior to screening.
• Participants who have stopped using metformin and/or GLP-1/GIP have done so at least 8 weeks prior to screening.
• Participants currently taking metformin and/or GLP-1/GIP 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.
• T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1 /GIP containing medications (e.g., Mounjaro), or Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.
• Participants who have stopped using metformin, GLP-1/GIP or SGLT2 have done so at least 8 weeks prior to screening.
• Participants currently taking metformin, GLP-1/GIP or SGLT2 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
• Is using sulfonylureas and meglitinides, e.g., repaglinide, in the 8 weeks prior to screening.
• Is using inhalable insulin in the 8 weeks prior to screening.
• Is using hydroxyurea at time of screening or plans to use it during the study
• 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.
• Is, at the discretion of the investigator, abusing drugs or alcohol.

Where it is running

• University of Otago - Dunedin Hospital — Dunedin, New Zealand (enrolling)
• Headlands Research California, LLC — Escondido, California, United States (enrolling)
• Sansum Diabetes Research Institute — Goleta, California, United States (enrolling)
• Loma Linda University Medical Center — Loma Linda, California, United States (enrolling)
• Sutter Institute for Medical Research — Sacramento, California, United States (enrolling)
• Royal North Shore Hospital — Sydney, New South Wales, Australia (enrolling)
• The Kids Research Institute Australia — Perth, Western Australia, Australia (enrolling)
• Medical Investigations — Little Rock, Arkansas, United States (enrolling)
• University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes — San Francisco, California, United States (enrolling)
• Mills-Peninsula Medical Center: Diabetes Research Institute — San Mateo, California, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States (enrolling)
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• USF Diabetes and Endocrinology Center — Tampa, Florida, United States (enrolling)
• Metabolic Research Institute — West Palm Beach, Florida, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
• Atlanta Diabetes Associates — Atlanta, Georgia, United States (enrolling)
• Endocrine Research Solutions — Roswell, Georgia, United States (enrolling)
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Indiana University Health Riley Hospital for Children — Indianapolis, Indiana, United States (enrolling)
• Iowa Diabetes and Endocrinology Center — West Des Moines, Iowa, United States (enrolling)
• Barry J. Reiner, MD LLC — Baltimore, Maryland, United States (enrolling)
• International Diabetes Center — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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