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

NCT07228117 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CIP351
• Study Type: interventional
• Target: 389
• Locations: 3 countries
• Sites: 33

Brief 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.

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL)

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

  Throughout the study period, approximately 90 days.

• Study Arm 1: Percent of Time in Hypoglycemia (< 70 mg/dL)

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

  Throughout the study period, approximately 90 days.

• Study Arm 2: Percent of Time in Range (TIR 70-180 mg/dL)

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

  Throughout the study period, approximately 90 days.

• Study Arm 2: Percent of Time in Hypoglycemia (< 70 mg/dL)

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

  Throughout the study period, approximately 90 days.

• Study Arm 3: Percent of Time in Range (TIR 70-180 mg/dL)

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

  Throughout the study period, approximately 90 days.

• Study Arm 3: Percent of Time in Hypoglycemia (< 70 mg/dL)

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

  Throughout the study period, approximately 90 days.

Study Arms (3)

Arm 1 - No meal bolus administration

EXPERIMENTAL

Patients will be asked not to bolus for any of their meals while using the NMX8 pump.

Device: MiniMed™ NMX8-AID System with DS5™/Simplera Sync™

Arm 2 - Meal bolus administration at all meals

EXPERIMENTAL

Patients will be asked to bolus for all of their meals while using the NMX8 pump.

Device: MiniMed™ NMX8-AID System with DS5™/Simplera Sync™

Arm 3 - Meal bolus administration at will

EXPERIMENTAL

Patients are free to bolus or not bolus for their meals as they wish using NMX8 pump.

Device: MiniMed™ NMX8-AID System with DS5™/Simplera Sync™

Interventions

MiniMed™ NMX8-AID System with DS5™/Simplera Sync™ DEVICE

Patients will be provided with the NMX8 system with DS5/Simplera Sync CGM.

Arm 1 - No meal bolus administration; Arm 2 - Meal bolus administration at all meals; Arm 3 - Meal bolus administration at will

Eligibility Criteria

• Age: 7 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at time of screening according to diabetes type:
• T1D: Age 7-85 years
• T2D: Age 18-85 years
• Has a clinical diagnosis of diabetes for a minimum per diabetes type below:
• T1D (Age 7-85 years): Diagnosis of T1D for at least 6 months, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
• T2D (Age 18-85 years): Diagnosis of insulin-requiring T2D for 1 year or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
• Is willing to provide informed consent/assent for participation.
• Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.
• Is willing to wear the system continuously throughout the study.
• Has results of a retinal eye examination on record prior to enrollment, per guidelines by the American Diabetes Association according to age, duration of diabetes and type of diabetes:
• T1D adults (Age 18-85 years):
• I. Initial retinal eye exam within 5 years of diagnosis. II. If the duration of type 1 diabetes is longer than 5 years, a retinal examination should have been performed within the last 12-18 months.
• T2D adults (Age 18-85 years):
• I. Results of a retinal eye exam, performed within the last 12-18 months, should be on record.
• T1D pediatric (Age 7-17 years):

You may not qualify if:

• Unable to consent due to a mental or intellectual disability.
• Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:
• Medical assistance (i.e., Paramedics, Emergency Room \[ER\] or Hospitalization)
• Coma or
• Seizures
• Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.
• T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
• Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Currently pregnant or planning to become pregnant during the time period of study participation
• A negative pregnancy test will be required for all females of child-bearing potential at time of screening
• For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable
• At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.
• Has diagnosis of adrenal insufficiency.
• Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.
• T1D: Is using non-insulin anti-hyperglycemic medication, other than metformin and/or Glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) containing medications (e.g., Mounjaro), in the 8 weeks prior to screening.

Sponsors & Collaborators

• Medtronic MiniMed, Inc.: lead

Study Sites (33)

Medical Investigations

Little Rock, Arkansas, 72211, United States

Location

Headlands Research California, LLC

Escondido, California, 92025, United States

Location

Sansum Diabetes Research Institute

Goleta, California, 93111, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95821, United States

Location

University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes

San Francisco, California, 94158, United States

Location

Mills-Peninsula Medical Center: Diabetes Research Institute

San Mateo, California, 94401, United States

Location

Stanford University Medical Center

Stanford, California, 94304, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06511, United States

Location

USF Diabetes and Endocrinology Center

Tampa, Florida, 33612, United States

Location

Metabolic Research Institute

West Palm Beach, Florida, 33401, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Indiana University Health Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Iowa Diabetes and Endocrinology Center

West Des Moines, Iowa, 50266, United States

Location

Barry J. Reiner, MD LLC

Baltimore, Maryland, 21229, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Bryan Physician Network

Lincoln, Nebraska, 68510, United States

Location

NYC Research Inc

Long Island City, New York, 11106, United States

Location

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Texas Diabetes & Endocrinology

Austin, Texas, 78731, United States

Location

Revival Research Institute

Denton, Texas, 76210, United States

Location

Tekton Research

McKinney, Texas, 75069, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Seattle Children's

Seattle, Washington, 98105, United States

Location

John Hunter Children's Hospital

New Lambton, New South Wales, 2305, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

The Kids Research Institute Australia

Perth, Western Australia, 6009, Australia

Location

University of Otago - Dunedin Hospital

Dunedin, 9016, New Zealand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: November 14, 2025
• Study Start: February 2, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); US (29); AU (3)