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GATEWAY: Safety of MiniMed™ NMX8-AID System for Diabetes

This study, called GATEWAY, is testing a new insulin pump system, the MiniMed™ NMX8-AID System, along with a continuous glucose monitor (CGM) called DS5™/Simplera Sync™. The main goal is to see if this system is safe for people with diabetes. It includes individuals with Type 1 diabetes (ages 7-85) and Type 2 diabetes (ages 18-85). Participants will first wear the DS5/Simplera sensor for up to 40 days while continuing their usual diabetes care. Then, they will use the NMX8 pump for about 90 days. Success will be measured by how much time participants spend with their blood sugar in a healthy range (70-180 mg/dL) and how much time they spend with low blood sugar (below 70 mg/dL). The current status of this study is unclear.

Study design
This is an interventional study with an estimated 400 participants. Participants will be randomly assigned to one of three groups after an initial observation period.
What's involved
You would first use your current therapy while wearing the DS5/Simplera sensor for up to 40 days, completing meal and exercise logs. Then, you would use the NMX8 pump for about 90 days, continuing to complete meal and exercise logs depending on your assigned group.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for measuring blood sugar levels are throughout the study period, approximately 90 days.

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NCT07228117

GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes

Recruiting
NAAges 7–85Interventional
Medtronic MiniMed, Inc.
~400 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:MiniMed™ NMX8-AID System with DS5™/Simplera Sync™

At a glance

Recruiting sites
34 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL)
Measured over Throughout the study period, approximately 90 days.
+5 more outcomes measured

Conditions

Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus

Explore related trials

Type 1 Diabetes MellitusType 2 Diabetes Mellitus

Where it's being run

38 sites across 22 states
California8
Georgia3
Texas3
Colorado2
Florida2
Nebraska2
Washington2
New South Wales2

Who to contact

Shannon Bondy
[email protected]
818-576-4912
Email the study team

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What this trial measures

  • Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL)Throughout the study period, approximately 90 days.

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

  • Study Arm 1: Percent of Time in Hypoglycemia (< 70 mg/dL)Throughout the study period, approximately 90 days.

    Percent of time in hypoglycemia (\< 70 mg/dL) among subjects randomized to Study Arm 1. Descriptive only.

  • Study Arm 2: Percent of Time in Range (TIR 70-180 mg/dL)Throughout the study period, approximately 90 days.

    Percent of time in range (TIR 70-180 mg/dL) among subjects randomized to Study Arm 2. Descriptive only.

  • Study Arm 2: Percent of Time in Hypoglycemia (< 70 mg/dL)Throughout the study period, approximately 90 days.

    Percent of time in hypoglycemia (\< 70 mg/dL) among subjects randomized to Study Arm 2. Descriptive only.

  • Study Arm 3: Percent of Time in Range (TIR 70-180 mg/dL)Throughout the study period, approximately 90 days.

    Percent of time in range (TIR 70-180 mg/dL) among subjects randomized to Study Arm 3. Descriptive only.

  • Study Arm 3: Percent of Time in Hypoglycemia (< 70 mg/dL)Throughout the study period, approximately 90 days.

    Percent of time in hypoglycemia (\< 70 mg/dL) among subjects randomized to Study Arm 3. Descriptive only.