Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
NCT07228117 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE MiniMed™ NMX8-AID System with DS5™
Study Locations (20)
California
- Headlands Research California, LLC — Escondido
- Sansum Diabetes Research Institute — Goleta
- Loma Linda University Medical Center — Loma Linda
- Sutter Institute for Medical Research — Sacramento
- Rady Children's Hospital - San Diego — San Diego
- University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes — San Francisco
- Mills-Peninsula Medical Center: Diabetes Research Institute — San Mateo
- Stanford University Medical Center — Stanford
Georgia
- Emory University School of Medicine — Atlanta
- Atlanta Diabetes Associates — Atlanta
- Endocrine Research Solutions — Roswell
Colorado
- Barbara Davis Center for Childhood Diabetes — Aurora
- Barbara Davis Center for Childhood Diabetes — Aurora
Arkansas
- Medical Investigations — Little Rock
Connecticut
- Yale University School of Medicine — New Haven
Florida
- USF Diabetes and Endocrinology Center — Tampa
Idaho
- Rocky Mountain Clinical Research — Idaho Falls
Illinois
- Northwestern University — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2026-02-02 |
| Est. Completion | 2026-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07228117
The ClinicalTrials.gov registry entry for NCT07228117 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Diabetes, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention — of which MiniMed™ NMX8-AID System with DS5™ is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07228117 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Georgia, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07228117 about?
NCT07228117 is a clinical study titled "GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes". 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 ...
What is the current status of trial NCT07228117?
This trial is currently recruiting. It is a NA study. The enrollment target is 400 participants. The study started on 2026-02-02. Estimated completion is 2026-12.
What conditions does trial NCT07228117 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07228117?
The interventions under investigation include: MiniMed™ NMX8-AID System with DS5™ (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07228117?
This trial is sponsored by Medtronic Diabetes, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07228117 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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