GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
Public ClinicalTrials.gov record NCT07228117. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07228117
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 389 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2, 2026 (Actual)
- Primary completion
- Jan 2027 (Estimated)
- Completion
- Jan 2027 (Estimated)
- Last update posted
- Sep 2, 2026
2026 – 2027
United States locations
- U.S. sites
- 29
- U.S. states
- 17
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Investigations | Little Rock | Arkansas | 72211 | — |
| Headlands Research California, LLC | Escondido | California | 92025 | — |
| Sansum Diabetes Research Institute | Goleta | California | 93111 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Sutter Institute for Medical Research | Sacramento | California | 95821 | — |
| University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes | San Francisco | California | 94158 | — |
| Mills-Peninsula Medical Center: Diabetes Research Institute | San Mateo | California | 94401 | — |
| Stanford University Medical Center | Stanford | California | 94304 | — |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | — |
| USF Diabetes and Endocrinology Center | Tampa | Florida | 33612 | — |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30303 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | — |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | — |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Indiana University Health Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Iowa Diabetes and Endocrinology Center | West Des Moines | Iowa | 50266 | — |
| Barry J. Reiner, MD LLC | Baltimore | Maryland | 21229 | — |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | — |
| Bryan Physician Network | Lincoln | Nebraska | 68510 | — |
| NYC Research Inc | Long Island City | New York | 11106 | — |
| University Diabetes and Endocrine Consultants | Chattanooga | Tennessee | 37411 | — |
| Texas Diabetes & Endocrinology | Austin | Texas | 78731 | — |
| Revival Research Institute | Denton | Texas | 76210 | — |
| Tekton Research | McKinney | Texas | 75069 | — |
| Rainier Clinical Research Center | Renton | Washington | 98057 | — |
| Seattle Children's | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07228117, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07228117 live on ClinicalTrials.gov.