GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes (NCT07228117)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Medical Investigations — Little Rock, Arkansas
Age range: 7 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (38 Sites)
Showing the first 25 of 38 sites.
- Medical Investigations — Little Rock, Arkansas
- Headlands Research California, LLC — Escondido, California
- Sansum Diabetes Research Institute — Goleta, California
- Loma Linda University Medical Center — Loma Linda, California
- Sutter Institute for Medical Research — Sacramento, California
- Rady Children's Hospital - San Diego — San Diego, California
- University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes — San Francisco, California
- Mills-Peninsula Medical Center: Diabetes Research Institute — San Mateo, California
- Stanford University Medical Center — Stanford, California
- Barbara Davis Center for Childhood Diabetes — Aurora, Colorado
- Barbara Davis Center for Childhood Diabetes — Aurora, Colorado
- Yale University School of Medicine — New Haven, Connecticut
- USF Diabetes and Endocrinology Center — Tampa, Florida
- Metabolic Research Institute — West Palm Beach, Florida
- Emory University School of Medicine — Atlanta, Georgia
- Atlanta Diabetes Associates — Atlanta, Georgia
- Endocrine Research Solutions — Roswell, Georgia
- Rocky Mountain Clinical Research — Idaho Falls, Idaho
- Northwestern University — Chicago, Illinois
- Indiana University Health Riley Hospital for Children — Indianapolis, Indiana
- Iowa Diabetes and Endocrinology Center — West Des Moines, Iowa
- Barry J. Reiner, MD LLC — Baltimore, Maryland
- International Diabetes Center — Minneapolis, Minnesota
- Bryan Physician Network — Lincoln, Nebraska
- University of Nebraska Medical Center — Omaha, Nebraska
📞 Contact the Study Coordinator
Phone: (818) 576-4912
Email: shannon.bondy@medtronic.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.