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NCT07228117 · ClinicalTrials.gov registry record · NA

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

A NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, sponsored by Medtronic Diabetes.

Recruiting
Registry status
NA
Development phase
400
Enrollment target
20
Study locations

NCT07228117 is a NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus that is actively recruiting participants, run by Medtronic Diabetes. The registered enrollment target is 400 participants, below the 2,745-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT07228117, a NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, is actively recruiting participants, sponsored by Medtronic Diabetes.

RECRUITING
Registry status
NA
Development phase
400 participants
Enrollment target
20
Study locations

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

Type 2 Diabetes Mellitus Type 1 Diabetes Mellitus

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

FieldValue
Enrollment Target 400 participants
Start Date 2026-02-02
Est. Completion 2026-12
Phase NA

Sponsor

Medtronic Diabetes

9 total trials

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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, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,745-participant average among 122 other Type 2 Diabetes Mellitus trials with a reported enrollment target (85% lower). The listed sponsor is Medtronic Diabetes, which has 9 total studies on file at ClinicalTrials.gov.

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.

NCT07228117 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Georgia, Colorado.

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.

What interventions are being tested in trial NCT07228117?

The interventions under investigation include: MiniMed™ NMX8-AID System with DS5™ (DEVICE).

Who is sponsoring clinical trial NCT07228117?

This trial is sponsored by Medtronic Diabetes, which has 9 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.