Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS) (NEXUS)

July 28, 2026 updated by: Medtronic MiniMed, Inc.

Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes

This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a pre-market, interventional, prospective, open-label, multi-center and randomized controlled clinical study.

The study consists of a run-in phase and a study phase.

Run-in Phase:

The purpose of the run-in phase is to collect baseline CGM data while subjects are on 780G therapy in Auto Mode. All subjects will use the Simplera Sync sensor.

At the end of the run-in phase, subjects will be randomly allocated to one of the two study arms (Treatment arm or Control arm).

Study Phase:

During the 12-week study phase, subjects will either start using the MiniMed™ NMX8 system (Treatment arm) or will continue to use the MiniMed™ 780G in Auto Mode (Control arm). During the study phase, all subjects will use the Simplera™ Sync sensor.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Antwerpen
        • Principal Investigator:
          • Christophe De Block
      • Brussels, Belgium
        • Not yet recruiting
        • Cliniques Universitaires de Bruxelles - Hôpital Erasme
        • Principal Investigator:
          • Laurent Crenier
      • Leuven, Belgium
        • Not yet recruiting
        • UZ Leuven
        • Principal Investigator:
          • Kristina Casteels
  • Denmark
      • Aarhus, Denmark
        • Not yet recruiting
        • steno diabetes center Aarhus
        • Principal Investigator:
          • Rakel Fuglsang Johansen
      • Herlev, Denmark
        • Not yet recruiting
        • Steno Diabetes Center Copenhagen
        • Principal Investigator:
          • Kirsten Noergaard
  • Israel
      • Ramat Gan, Israel
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Amir Tirosh
      • Ramat Gan, Israel
        • Not yet recruiting
        • Sheba Medical Center, Edmond and Lily Safra Children's Hospital
        • Principal Investigator:
          • Noah Gruber
  • Slovenia
      • Ljubljana, Slovenia
        • Not yet recruiting
        • University Medical Centre Ljubljana
        • Principal Investigator:
          • Klemen Dovc

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Is aged ≥2 years old at time of screening.
  2. Has a clinical diagnosis of Type 1 or Type 2 diabetes for ≥ 6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.
  3. Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.
  4. Has a glycosylated hemoglobin (HbA1c) <11% (97 mmol/mol) at time of screening visit as processed at Point of Care (PoC) or local lab.
  5. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units
  6. Willing to switch to approved insulin per insulin pump labeling.
  7. Investigator has confidence that the subject, parent(s)/legal guardian(s) can successfully operate all study devices and is capable of adhering to study visit schedule per protocol.
  8. Subject, Parent(s)/legal guardian(s) is willing to participate in all training sessions as directed by study staff.
  9. Subject, Parent(s)/legal guardian(s) is willing and able to provide written informed consent.
  10. For subject with Type 2 Diabetes only: Is on stable dose of anti-diabetic medication (other than insulin) (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors) for the last 3 months prior to screening. NB: Subject should not change type or dose of medication during the course of the study.
  11. For Israel only: Subject, Parents(s)/legal guardian(s) is fluent in English.

Exclusion Criteria:

  1. Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.
  2. For subjects with Type 1 Diabetes only: Is using any anti-diabetic medication other than insulin 6 months before screening or plan on using during the study (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors).
  3. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any chronically oral, injectable, or IV glucocorticoids during the course of the study, per investigator judgement
  4. Has had renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 6 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
  5. Has active or severe retinopathy in the last 6 months before screening
  6. Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
  7. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
  8. History of 2 or more DKA events in the last 3 months before screening.
  9. Has had Hyperosmolar Hyperglycemic State (HHS) in the last 6 months before screening.
  10. Is using hydroxyurea at time of screening or plans to use it during the study
  11. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
  12. Women who are breastfeeding.
  13. Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before screening, as per investigator judgment.
  14. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
  15. Subject, Parent(s)/legal guardian(s) are part of research staff involved with the study.
  16. Subject, Parent(s)/legal guardian (s) are legally incompetent, illiterate, or vulnerable.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment arm (NMX8)
Subjects randomized to the Treatment group will use the MiniMed™ NMX8 system
Device: NMX8
Subjects will start using the MiniMed™ NMX8 system for 12 weeks
Active Comparator: Control arm (780G)
Subjects randomized to the Control arm will continue to use the MiniMed™ 780G.
Device: 780G
Subjects will continue to use the MiniMed™ 780G for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Endpoint
Time Frame: During the 12-week study phase
The between-treatment (control arm with 780G system versus treatment arm with NMX8 system) difference during the study phase in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) with a non-inferiority testing.
During the 12-week study phase

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Endpoint 1
Time Frame: End of 12-week Study Phase
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with a non-inferiority testing.
End of 12-week Study Phase
Secondary endpoint 2
Time Frame: During the 12-week Study Phase
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in % of Time spent in target range (70 to 180 mg/dL [3.9 - 10.0 mmol/L]) during the study phase with superiority test.
During the 12-week Study Phase
Secondary Endpoint 3
Time Frame: End of the 12-week Study Phase
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with superiority testing.
End of the 12-week Study Phase

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic MiniMed, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Pr. Ohad Cohen, MD, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP352

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

product manufactured in and exported from the U.S.

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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