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Type 1 Diabetes MellitusNCT07228117

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

A study testing MiniMed™ NMX8-AID System with DS5™/Simplera Sync™ in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 33 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 85 years
What is being tested?
MiniMed™ NMX8-AID System with DS5™/Simplera Sync™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
389 participants
Where
33 sitesin 3 countries
Study dates
2 Feb 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 29Show fewer
  • 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):
  • 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):
  • Results of a retinal eye exam, performed within the last 12-18 months, should be on record.
  • T1D pediatric (Age 7-17 years):
  • No exam is required if under the age of 10 years unless the duration of diabetes is more than 3 years.
  • 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.
  • Is willing to upload study pump data via an app or computer.
  • Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:
  • Humalog™* (insulin lispro injection)
  • NovoLog™* (insulin aspart solution for injection) or an interchangeable biosimilar (for example, Kirsty™*)
  • NovoRapid™* (insulin aspart solution for injection)
  • Admelog™* (insulin lispro injection)
  • Merilog™* (insulin aspart)
  • Fiasp™* (ultra-rapid-acting insulin aspart)
  • Lyumjev™* (ultra-rapid-acting insulin lispro)
  • Authorized generic insulin aspart
  • Authorized generic insulin lispro

Who cannot join

  • 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.
Show all 43Show fewer
  • 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.
  • Participants who have stopped using metformin and/or GLP-1/GIP have done so at least 8 weeks prior to screening.
  • Participants currently taking metformin and/or GLP-1/GIP must be on a steady dose and remain on the same dose during study participation until the end of the study period.
  • During continued access, starting/stopping the medication and/or modifying doses will be permitted.
  • Dose changes and reasons for changes will be documented throughout the study.
  • T2D: Is using non-insulin anti-hyperglycemic medication, other than metformin, GLP-1 /GIP containing medications (e.g., Mounjaro), DPP-4 Inhibitors, thiazolidinedione (TZD), or Sodium-Glucose Cotransporter 2 (SGLT2) inhibitors, in the 8 weeks prior to screening.
  • Participants who have stopped using metformin, GLP-1/GIP, DPP-4 Inhibitors, TZD, or SGLT2 have done so at least 8 weeks prior to screening.
  • Participants currently taking metformin, GLP-1/GIP, DPP-4 Inhibitors, TZD, or SGLT2 must be on a steady dose and remain on the same dose during study participation, until the end of the study period.
  • During continued access, starting/stopping the medication and/or modifying doses will be permitted.
  • Dose changes and reasons for changes will be documented throughout the study
  • Is using sulfonylureas and meglitinides, e.g., repaglinide, in the 8 weeks prior to screening.
  • Is using inhalable insulin in the 8 weeks prior to screening.
  • Is using hydroxyurea at time of screening or plans to use it during the study
  • 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.
  • Is, at the discretion of the investigator, abusing drugs or alcohol.
  • Is, in the opinion of the investigator, not able to perform all study procedures safely.
  • 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.
  • Has elective surgery planned that requires general anesthesia during the course of the study.
  • Has sickle cell disease or other hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
  • Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
  • Is diagnosed with current eating disorder such as anorexia or bulimia.
  • Blood disorder or dyscrasia within 3 months prior to screening, which in the investigator's opinion could interfere with determination of HbA1c
  • Is on dialysis.
  • Has an estimated Glomerular Filtration Rate (eGFR) <30. For T1D subjects who are within the first 5 years after diagnosis, a new eGFR test is not required for screening; however, if an eGFR value taken during the first 5 years from diagnosis is available, and if it is <30, the subject will be excluded.
  • Has celiac disease that is not adequately treated as determined by the investigator.
  • 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.
  • 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.
  • Is a member of the research staff involved with the study.
  • Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).

Trial locations and contacts

33 sites in 3 countries.

33 sites in 3 countries

United States29 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30303

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80045

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78731

  • Barry J. Reiner, MD LLC

    Baltimore, Maryland, 21229

  • University Diabetes and Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Northwestern University

    Chicago, Illinois, 60611

  • Revival Research Institute

    Denton, Texas, 76210

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Sansum Diabetes Research Institute

    Goleta, California, 93111

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Indiana University Health Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Bryan Physician Network

    Lincoln, Nebraska, 68510

  • Medical Investigations

    Little Rock, Arkansas, 72211

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • NYC Research Inc

    Long Island City, New York, 11106

  • Tekton Research

    McKinney, Texas, 75069

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Yale University School of Medicine

    New Haven, Connecticut, 06511

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Endocrine Research Solutions

    Roswell, Georgia, 30076

  • 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

  • Seattle Children's

    Seattle, Washington, 98105

  • Stanford University Medical Center

    Stanford, California, 94304

  • USF Diabetes and Endocrinology Center

    Tampa, Florida, 33612

  • Iowa Diabetes and Endocrinology Center

    West Des Moines, Iowa, 50266

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401

Other trials in United States

Australia3 sites

  • John Hunter Children's Hospital

    New Lambton, New South Wales, 2305

  • The Kids Research Institute Australia

    Perth, Western Australia, 6009

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065

Other trials in Australia

New Zealand1 site

  • University of Otago - Dunedin Hospital

    Dunedin, 9016

Other trials in New Zealand

About this study

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.

Being tested
MiniMed™ NMX8-AID System with DS5™/Simplera Sync™
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT07228117
Study groupRoleWhat they receive
Arm 1 - No meal bolus administrationExperimentalPatients will be asked not to bolus for any of their meals while using the NMX8 pump.
Receives: Device: MiniMed™ NMX8-AID System with DS5™/Simplera Sync™
Arm 2 - Meal bolus administration at all mealsExperimentalPatients will be asked to bolus for all of their meals while using the NMX8 pump.
Receives: Device: MiniMed™ NMX8-AID System with DS5™/Simplera Sync™
Arm 3 - Meal bolus administration at willExperimentalPatients are free to bolus or not bolus for their meals as they wish using NMX8 pump.
Receives: Device: MiniMed™ NMX8-AID System with DS5™/Simplera Sync™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Throughout the study period, approximately 90 days.

  2. 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.

    Measured: Throughout the study period, approximately 90 days.

  3. 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.

    Measured: Throughout the study period, approximately 90 days.

  4. 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.

    Measured: Throughout the study period, approximately 90 days.

  5. 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.

    Measured: Throughout the study period, approximately 90 days.

  6. 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.

    Measured: Throughout the study period, approximately 90 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2025
  2. Study start2 Feb 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
389 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07228117
Sponsor's protocol ID
CIP351
Status last verified
Sep 2026
First submitted
11 Nov 2025
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MiniMed™ NMX8-AID System with DS5™/Simplera Sync™ in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by Medtronic MiniMed, Inc. at 33 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL) (time frame: Throughout the study period, approximately 90 days.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07228117.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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