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Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes

NCT07401901 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-04-28

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system (referred also to as NMX8 system), in comparison with other commercially available AID systems (Automated insulin delivery) in adult patients with Type 1 diabetes not achieving target clinical outcomes.

Conditions

  • Type 1 Diabetes (T1D)

Interventions

DEVICE

NMX8 System - Treatment arm

Subjects start using the NMX8 system after the run-in phase and continue through both study (6-month) and continuation phases (3-month).

DEVICE

AID Therapy

Subjects will continue to use their current AID therapy during the study phase (6-month).

DEVICE

NMX8 System - Control Arm

Subjects start using the NMX8 system during the continuation phases (3-month).

Sponsors & Collaborators

  • Medtronic MiniMed, Inc.

    lead INDUSTRY

Principal Investigators

  • Prof. Ohad Cohen, MD · Medtronic MiniMed, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-15
Primary Completion
2027-12-04
Completion
2028-03-29
FDA Device
Yes

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07401901 on ClinicalTrials.gov