Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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 2,957-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

Percent of time in range (TIR 70-180 mg/dL) among subjects randomized to Study Arm 1. Descriptive only.

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
Medtronic Diabetes

9 total trials

What NCT07228117 shows while recruiting

NCT07228117 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 2,957-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (86% lower).

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 names 20 study sites across 10 states, led by 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.

Learn More About Clinical Trials

Similar trials for Type 2 Diabetes Mellitus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07228117's enrollment target sits among peer trials

400 23rd of 130 higher than 108 of 130 other Type 2 Diabetes Mellitus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01665326 · 400 participants

    Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease

  • NCT02108054 · 400 participants · NA

    Behavioral and Functional Task Development, Implementation, and Testing

  • NCT02216500 · 400 participants · NA

    Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy

  • NCT02250352 · 400 participants

    Core Biopsies for Establishing a Breast Tumor Tissue Repository

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT07228117

Source: ClinicalTrials.gov NCT07228117, the US trial registry maintained by the National Library of Medicine. NCT07228117 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.