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type1.science
N/A (device / behavioral)Active, not recruitingNCT07228117

GATEWAY: MiniMed Flex / NMX8-AID with Simplera Sync

What this study tests

MiniMed pivotal safety study of the system now publicly launched as MiniMed Flex and still registered under the NMX8-AID name, paired with the DS5 / Simplera Sync sensor. Participants use current therapy with the sensor first, then about 90 days of Flex/NMX8 in one of three meal-bolus modes, including a no-meal-bolus arm. Flex received FDA clearance in March 2026, but GATEWAY outcomes are not posted yet.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-09-02.

Most recent recorded citation date: 2026-06-08. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
People with type 1 diabetes aged 7-85 and people with type 2 diabetes aged 18-85. The T1D subgroup is the relevant population for this site. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No results posted. The registry lists active, not recruiting, with 389 participants actually enrolled, an actual start of 2 February 2026 and estimated primary/study completion in January 2027 (updated 2 September 2026). FDA clearance of a product is separate from publication of this trial’s results.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United States, Australia, Other regions. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.

Australian sites in the registry

  • John Hunter Children's Hospital, New Lambton, New South Wales — Site status not reported
  • Royal North Shore Hospital, Sydney, New South Wales — Site status not reported
  • The Kids Research Institute Australia, Perth, Western Australia — Site status not reported

Overall recruitment does not imply availability at every site. Confirm eligibility and local recruitment with the study team.

Primary endpoints

  • Time in range 70-180 mg/dL during approximately 90 days of NMX8 use
  • Time below 70 mg/dL during approximately 90 days of NMX8 use

The full picture

This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.

Sources

  1. [1]
  2. [2]