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

June 4, 2026 updated by: Medtronic MiniMed, Inc.
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • New Lambton, New South Wales, Australia, 2305
        • Recruiting
        • John Hunter Children's Hospital
        • Contact:
        • Principal Investigator:
          • Bruce King
      • Sydney, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
        • Principal Investigator:
          • Sarah Glastras
        • Contact:
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Recruiting
        • The Kids Research Institute Australia
        • Contact:
        • Principal Investigator:
          • Timothy Jones
  • New Zealand
      • Dunedin, New Zealand, 9016
        • Recruiting
        • University of Otago - Dunedin Hospital
        • Contact:
        • Principal Investigator:
          • Benjamin Wheeler
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Medical Investigations
        • Principal Investigator:
          • James Thrasher, M.D.
        • Contact:
    • California
      • Escondido, California, United States, 92025
      • Goleta, California, United States, 93111
        • Recruiting
        • Sansum Diabetes Research Institute
        • Principal Investigator:
          • Kristin Castorino, D.O.
        • Contact:
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:
        • Principal Investigator:
          • Scott Lee, M.D.
      • Sacramento, California, United States, 95821
        • Recruiting
        • Sutter Institute for Medical Research
        • Principal Investigator:
          • Gnanagurudasan Prakasam, M.D.
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital - San Diego
        • Contact:
        • Principal Investigator:
          • Carla Demeterco-Berggren, M.D.
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes
        • Principal Investigator:
          • Laya Ekhlaspour, M.D.
        • Contact:
      • San Mateo, California, United States, 94401
        • Recruiting
        • Mills-Peninsula Medical Center: Diabetes Research Institute
        • Contact:
        • Principal Investigator:
          • David Klonoff, M.D.
      • Stanford, California, United States, 94304
        • Recruiting
        • Stanford University Medical Center
        • Contact:
        • Principal Investigator:
          • Rayhan Lal, M.D.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Barbara Davis Center for Childhood Diabetes
        • Contact:
        • Principal Investigator:
          • Halis Akturk, M.D.
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale University School of Medicine
        • Principal Investigator:
          • Jennifer Sherr, M.D.
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • USF Diabetes and Endocrinology Center
        • Contact:
        • Principal Investigator:
          • Dorothy Shulman, M.D.
      • West Palm Beach, Florida, United States, 33401
        • Not yet recruiting
        • Metabolic Research Institute
        • Contact:
        • Principal Investigator:
          • Barry Horowitz, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University School of Medicine
        • Principal Investigator:
          • Francisco Pasquel, M.D.
        • Contact:
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Atlanta Diabetes Associates
        • Principal Investigator:
          • Bruce Bode, M.D.
        • Contact:
      • Roswell, Georgia, United States, 30076
        • Recruiting
        • Endocrine Research Solutions
        • Contact:
        • Principal Investigator:
          • John Reed, M.D.
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Rocky Mountain Clinical Research
        • Principal Investigator:
          • David Liljenquist, M.D.
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Grazia Aleppo-Kacmarek, M.D.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Riley Hospital for Children
        • Contact:
        • Principal Investigator:
          • Linda DiMeglio, M.D.
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Iowa Diabetes and Endocrinology Center
        • Contact:
        • Principal Investigator:
          • Anuj Bhargava, M.D.
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Not yet recruiting
        • Barry J. Reiner, MD LLC
        • Contact:
        • Principal Investigator:
          • Barry Reiner, M.D.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Recruiting
        • International Diabetes Center
        • Principal Investigator:
          • Anders Carlson, M.D.
        • Contact:
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Recruiting
        • Bryan Physician Network
        • Contact:
        • Principal Investigator:
          • Shannon Wakeley, M.D.
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Shubham Agarwal, M.D.
    • New York
      • Long Island City, New York, United States, 11106
        • Recruiting
        • NYC Research INC
        • Contact:
        • Principal Investigator:
          • Anastasios Manessis, M.D.
    • North Carolina
      • Arden, North Carolina, United States, 28704
        • Not yet recruiting
        • Pardee BlueMD Endocrinology
        • Contact:
        • Principal Investigator:
          • Wendy Lane, M.D.
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
        • Principal Investigator:
          • Sarah MacLeish, D.O.
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Not yet recruiting
        • University Diabetes and Endocrine Consultants
        • Contact:
        • Principal Investigator:
          • David Huffman, M.D.
    • Texas
      • Austin, Texas, United States, 78731
        • Not yet recruiting
        • Texas Diabetes & Endocrinology
        • Principal Investigator:
          • Luis Casaubon, M.D.
        • Contact:
      • Denton, Texas, United States, 76210
        • Recruiting
        • Revival Research Institute
        • Contact:
        • Principal Investigator:
          • Seema Haq, M.D.
      • McKinney, Texas, United States, 75069
    • Washington
      • Renton, Washington, United States, 98057
        • Recruiting
        • Rainier Clinical Research Center
        • Principal Investigator:
          • Frances Broyles, M.D.
        • Contact:
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age at time of screening according to diabetes type:

    1. T1D: Age 7-85 years
    2. T2D: Age 18-85 years

  2. Has a clinical diagnosis of diabetes for a minimum per diabetes type below:

    1. 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.
    2. 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
  3. Is willing to provide informed consent/assent for participation.
  4. Subject or parent/caregiver is literate and able to read the language (English or Spanish) offered in the study pump or study pump materials.
  5. Is willing to wear the system continuously throughout the study.

  6. 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:

    1. 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.

    2. T2D adults (Age 18-85 years):

      I. Results of a retinal eye exam, performed within the last 12-18 months, should be on record.

    3. T1D pediatric (Age 7-17 years):

    I. No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years.

    II. For children over the age of 10, a retinal exam should have been performed within 24 months of enrollment in the study.

    Per the investigator's discretion: If a potential participant is deemed to be at high risk, a retinal eye exam, performed within the last 12 months prior to screening, should be on record.

  7. Is willing to upload study pump data via an app or computer.

  8. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:

    1. Humalog™* (insulin lispro injection)
    2. NovoLog™* (insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™*)
    3. NovoRapid™* (insulin aspart solution for injection)
    4. Admelog™* (insulin lispro injection)
    5. Merilog™* (insulin aspart)
    6. Fiasp™* (ultra-rapid-acting insulin aspart)
    7. Lyumjev™* (ultra-rapid-acting insulin lispro)
    8. Authorized generic insulin aspart
    9. Authorized generic insulin lispro

Exclusion Criteria:

  1. Unable to consent due to a mental or intellectual disability.

  2. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following, during the 6 months prior to screening:

    1. Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)
    2. Coma or
    3. Seizures
  3. Has a history of 1 or more episodes of diabetic ketoacidosis (DKA) in the last 6 months prior to screening visit.
  4. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
  5. Has any unresolved adverse skin condition in the area of sensor or infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

  6. Currently pregnant or planning to become pregnant during the time period of study participation

    1. A negative pregnancy test will be required for all females of child-bearing potential at time of screening
    2. 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
  7. At investigator discretion, has hypothyroidism or hyperthyroidism that is not adequately treated.
  8. Has diagnosis of adrenal insufficiency.
  9. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit.

  10. 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.

    1. Participants who have stopped using metformin and/or GLP-1/GIP have done so at least 8 weeks prior to screening.
    2. Participants currently taking metformin and/or GLP-1/GIP must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study.

  11. T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1 /GIP containing medications (e.g., Mounjaro), or Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.

    1. Participants who have stopped using metformin, GLP-1/GIP or SGLT2 have done so at least 8 weeks prior to screening.
    2. Participants currently taking metformin, GLP-1/GIP or SGLT2 must be on a steady dose and remain on the same dose during study participation. Dose changes and reasons for changes will be documented throughout the study
  12. Is using sulfonylureas and meglitinides, e.g., repaglinide, in the 8 weeks prior to screening.
  13. Is using inhalable insulin in the 8 weeks prior to screening.
  14. Is using hydroxyurea at time of screening or plans to use it during the study
  15. Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study.
  16. Is, at the discretion of the investigator, abusing drugs or alcohol.
  17. Is, in the opinion of the investigator, not able to perform all study procedures safely.
  18. Has a history of visual impairment which would not allow subject, even with the help of a caregiver, to participate in the study and perform all study procedures safely, as determined by the investigator.
  19. Has elective surgery planned that requires general anesthesia during the course of the study.
  20. Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
  21. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
  22. Is diagnosed with current eating disorder such as anorexia or bulimia.
  23. Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c
  24. Is on dialysis.
  25. Has an estimated Glomerular Filtration Rate (eGFR) <30.
  26. Has celiac disease that is not adequately treated as determined by the investigator.
  27. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
  28. Has had any of the following cardiovascular events more than 1 year prior to screening and should not participate at the discretion of the investigator: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
  29. Is a member of the research staff involved with the study.
  30. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - No meal bolus administration
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™
Patients will be provided with the NMX8 system with DS5/Simplera Sync CGM.
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.
Device: MiniMed™ NMX8-AID System with DS5™/Simplera Sync™
Patients will be provided with the NMX8 system with DS5/Simplera Sync CGM.
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.
Device: MiniMed™ NMX8-AID System with DS5™/Simplera Sync™
Patients will be provided with the NMX8 system with DS5/Simplera Sync CGM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL)
Time Frame: 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.
Throughout the study period, approximately 90 days.
Study Arm 1: Percent of Time in Hypoglycemia (< 70 mg/dL)
Time Frame: Throughout the study period, approximately 90 days.
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)
Time Frame: 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.
Throughout the study period, approximately 90 days.
Study Arm 2: Percent of Time in Hypoglycemia (< 70 mg/dL)
Time Frame: Throughout the study period, approximately 90 days.
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)
Time Frame: 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.
Throughout the study period, approximately 90 days.
Study Arm 3: Percent of Time in Hypoglycemia (< 70 mg/dL)
Time Frame: Throughout the study period, approximately 90 days.
Percent of time in hypoglycemia (< 70 mg/dL) among subjects randomized to Study Arm 3. Descriptive only.
Throughout the study period, approximately 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic MiniMed, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 11, 2025

First Submitted That Met QC Criteria

November 11, 2025

First Posted (Actual)

November 14, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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