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NotablePrimary endpoint(s) modifiedPrimary and study completion moved earlier from Feb 2027 to Jan 2027 · Study sites: 36 to 38 · Interventions: MiniMed™ NMX8-AID System with DS5™ (Device) to MiniMed™ NMX8-AID System with DS5™/Simplera Sync™ (Device)v6Show 3 more changesShow less
Primary and study completion moved earlier from Feb 2027 to Jan 2027
Study sites: 36 to 38
Interventions: MiniMed™ NMX8-AID System with DS5™ (Device) to MiniMed™ NMX8-AID System with DS5™/Simplera Sync™ (Device)
MinorPrimary and study completion pushed from Dec 2026 to Feb 2027Trial sites expanded: 33 → 36 locations · Eligibility criteria expanded, about 170 wordsv5Show 2 more changesShow less
NotableChangedSponsor changed: Medtronic Diabetes to Medtronic MiniMed, Inc.
NotableTrial status: Not Yet Recruiting to RecruitingStart date changed from estimate of Feb 2026 to Feb 2, 2026 · Site details revised at 33 of 33 sitesv4Show 2 more changesShow less
Start date changed from estimate of Feb 2026 to Feb 2, 2026
Site details revised at 33 of 33 sites
NotableStart date: Dec 2025 to Feb 2026Study sites revised (33)v3Show 1 more changeShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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/Simplera Sync 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. Participants will use their current therapy while also wearing the DS5/Simplera sensor for up to 40 days. During this time, they will complete a meal and exercise log. Participants will then be placed into one of three groups by chance and given the NMX8 pump to use for about 90 days. During this time, participants will bolus, not bolus, or bolus at will 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 participants 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.