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

NCT07227805 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CIP352
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2)

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  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 Outcomes (3)

• Secondary Endpoint 1

  End of 12-week Study Phase

• Secondary endpoint 2

  During the 12-week Study Phase

• Secondary Endpoint 3

  End of the 12-week Study Phase

Study Arms (2)

Treatment arm (NMX8)

EXPERIMENTAL

Subjects randomized to the Treatment group will use the MiniMed™ NMX8 system

Device: NMX8

Control arm (780G)

ACTIVE COMPARATOR

Subjects randomized to the Control arm will continue to use the MiniMed™ 780G.

Device: 780G

Interventions

NMX8 DEVICE

Subjects will start using the MiniMed™ NMX8 system for 12 weeks

Treatment arm (NMX8)

780G DEVICE

Subjects will continue to use the MiniMed™ 780G for 12 weeks

Control arm (780G)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Is aged ≥2 years old at time of screening.
• 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.
• Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.
• Has a glycosylated hemoglobin (HbA1c) \<11% (97 mmol/mol) at time of screening visit as processed at Point of Care (PoC) or local lab.
• Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units
• Willing to switch to approved insulin per insulin pump labeling.
• 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.
• Subject, Parent(s)/legal guardian(s) is willing to participate in all training sessions as directed by study staff.
• Subject, Parent(s)/legal guardian(s) is willing and able to provide written informed consent.
• 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.
• For Israel only: Subject, Parents(s)/legal guardian(s) is fluent in English.

You may not qualify if:

• Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.
• 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).
• 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
• 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.
• Has active or severe retinopathy in the last 6 months before screening
• Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
• History of 2 or more DKA events in the last 3 months before screening.
• Has had Hyperosmolar Hyperglycemic State (HHS) in the last 6 months before screening.
• Is using hydroxyurea at time of screening or plans to use it during the study
• Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
• Women who are breastfeeding.
• 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.
• Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
• Subject, Parent(s)/legal guardian(s) are part of research staff involved with the study.

Sponsors & Collaborators

• Medtronic Diabetes: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pr. Ohad Cohen, MD

  Medtronic Diabetes

  STUDY CHAIR

Central Study Contacts

Bérangère Lacroix

CONTACT

+41764164283; berangere.lacroix@medtronic.com

Renée Tillie

CONTACT

renee.tillie@medtronic.com

Study Design

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

Study Record Dates

• First Submitted: November 11, 2025
• First Posted: November 13, 2025
• Study Start: June 15, 2026
• Primary Completion (Estimated): March 17, 2027
• Study Completion (Estimated): March 17, 2027
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share