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

Sponsor
Medtronic MiniMed, Inc.
Study ID
NCT07401901
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NMX8 System - Treatment arm — DEVICE
    Subjects start using the NMX8 system after the run-in phase and continue through both study (6-month) and continuation phases (3-month).
  • AID Therapy — DEVICE
    Subjects will continue to use their current AID therapy during the study phase (6-month).
  • NMX8 System - Control Arm — DEVICE
    Subjects start using the NMX8 system during the continuation phases (3-month).

Study Details

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.

Key Dates

First listed
Feb 11, 2026
Start date
Oct 15, 2026
Status verified
Apr 2026
Primary completion
Dec 4, 2027
Completion
Mar 29, 2028

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm (NMX8 system)
    Subjects randomized to the Treatment group will use the MiniMed NMX8 system
  • Active Comparator: Control arm (AID Therapy)
    Subjects randomized to the Control group will continue to use their current AID therapy during the study phase for 6-month. During the continuation phase, subjects in the Control group will use the NMX8 system for 3-month.

Primary Outcome Measure

Primary Endpoint [ Time Frame: End of 6-month study phase ]

Central Contacts

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