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

116 participantsStarted 2026-06-15

Plain-language 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.

Who can participate

Age range2 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Primary Endpoint

Timeframe: During the 12-week study phase

Trial details

NCT IDNCT07227805

SponsorMedtronic MiniMed, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-17

Contact for this trial

Bérangère Lacroix

+41764164283 berangere.lacroix@medtronic.com

View on ClinicalTrials.gov More Diabetes (Insulin-requiring, Type 1 or Type 2) trials