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

Conditions

• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Eligibility Criteria

Sex

ALL

Age

7 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• MiniMed™ NMX8-AID System with DS5™/Simplera Sync™ — DEVICE
  Patients will be provided with the NMX8 system with DS5/Simplera Sync CGM.

Study Details

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.

Key Dates

Start date

Feb 2, 2026

Status verified

May 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: Arm 1 - No meal bolus administration
  Patients will be asked not to bolus for any of their meals while using the NMX8 pump.
• Experimental: Arm 2 - Meal bolus administration at all meals
  Patients will be asked to bolus for all of their meals while using the NMX8 pump.
• Experimental: Arm 3 - Meal bolus administration at will
  Patients are free to bolus or not bolus for their meals as they wish using NMX8 pump.

Primary Outcome Measure

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

Central Contacts

• Shannon Bondy
  818-576-4912
  [email protected]
• Thomas Troub
  818-576-3142
  [email protected]

Locations (34)

Find similar trials in Little Rock, AR

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