GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
Condition(s) studied
Investigational drug(s) / intervention(s)
MiniMed™ NMX8-AID System with DS5™/Simplera Sync™: Patients will be provided with the NMX8 system with DS5/Simplera Sync CGM.
Study summary
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.
Eligibility
Primary outcome measure(s)
- 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.
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| NYC Research Inc | Long Island City | New York | |
| University Diabetes and Endocrine Consultants | Chattanooga | Tennessee | |
| Texas Diabetes & Endocrinology | Austin | Texas | |
| Revival Research Institute | Denton | Texas | |
| Tekton Research | McKinney | Texas | |
| Rainier Clinical Research Center | Renton | Washington | |
| Seattle Children's | Seattle | Washington | |
| John Hunter Children's Hospital | New Lambton | New South Wales | |
| Royal North Shore Hospital | Sydney | New South Wales | |
| The Kids Research Institute Australia | Perth | Western Australia | |
| University of Otago - Dunedin Hospital | Dunedin | New Zealand |
More Medtronic MiniMed, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07228117 on ClinicalTrials.gov ↗ ← All trials in the USA