Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes

NCT07401901 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CIP353
• Study Type: interventional
• Target: 230
• Locations: 6 countries
• Sites: 21

Brief Summary

The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system (referred also to as NMX8 system), in comparison with other commercially available AID systems (Automated insulin delivery) in adult patients with Type 1 diabetes not achieving target clinical outcomes.

Conditions

Type 1 Diabetes (T1D)

Keywords

Automated insulin delivery (AID); Diabetes

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in the percentage of time that the sensor glucose (SG) measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) at the end of the study phase . The endpoint will be assessed for non-inferiority.

  End of 6-month study phase

Secondary Outcomes (3)

• Secondary Endpoint 1

  End of 6-month study phase.

• Secondary Endpoint 2

  End of 6-month study phase.

• Secondary Endpoints 3

  End of 6-month study phase.

Study Arms (2)

Treatment arm (NMX8 system)

EXPERIMENTAL

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

Device: NMX8 System - Treatment arm

Control arm (AID Therapy)

ACTIVE COMPARATOR

Subjects randomized to the Control group will continue to use their current AID therapy during the study phase for 6-month. During the continuation phase, subjects in the Control group will use the NMX8 system for 3-month.

Device: AID Therapy; Device: NMX8 System - Control Arm

Interventions

NMX8 System - Treatment arm DEVICE

Subjects start using the NMX8 system after the run-in phase and continue through both study (6-month) and continuation phases (3-month).

Treatment arm (NMX8 system)

AID Therapy DEVICE

Subjects will continue to use their current AID therapy during the study phase (6-month).

Control arm (AID Therapy)

NMX8 System - Control Arm DEVICE

Subjects start using the NMX8 system during the continuation phases (3-month).

Control arm (AID Therapy)

Eligibility Criteria

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

You may qualify if:

• Is aged ≥ 18 years old at time of screening.
• Has a clinical diagnosis of Type 1 diabetes for ≥6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.
• Is on commercially approved AID therapy (e.g. MiniMed 780G, Control IQ, OmniPod 5, CamAPS FX) for at least 3 months before screening.
• Has a glycosylated hemoglobin (HbA1c) above ≥7.5 % (59 mmol/mol), therefore is not achieving therapy goal, at time of screening visit (as processed by a Central Lab).
• Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units.
• Has shown good compliance (≥70%) with sensor wear over the previous month prior to enrollment (based on sensor usage from the download summary report over the 30 days prior to enrollment).
• Is willing to switch to an approved insulin per insulin pump labeling.
• Is willing to participate in all training sessions as directed by study staff.
• Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol.
• Subject is willing and able to provide written informed consent.

You may not qualify if:

• Has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
• Is using any anti-diabetic medication other than insulin at the time of the 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 chronically any oral, injectable, or IV glucocorticoids during the course of the study.
• 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 any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Has active or severe retinopathy in the last 6 months before the screening.
• Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
• Has a positive pregnancy test at screening or plan to become pregnant during the course of the study or is breast feeding at the time of the enrollment.
• Note: Different effective contraception methods may be used such as contraceptive pills, condoms, intra-uterine device, patches, rings, or long-active reversible contraceptive methods, as per routine practice.
• History of 2 or more DKA events in the last 3 months before screening.
• Is on "DIY" therapy at the time of the screening or at least 3 months before the screening.
• Is planning to change AID therapy during the course of the study. Note: subjects randomized in the Control Arm should remain on their current therapy during the course of the study.
• 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 enrollment into this study, as per investigator judgment.
• Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
• Is part of the research staff involved with the study.

Sponsors & Collaborators

• Medtronic MiniMed, Inc.: lead

Study Sites (21)

Centre Hospitalier Universitaire de Caen

Caen, France

Location

Hôpital Michallon - CHU Grenoble

Grenoble, France

Location

Hospices Civils de Lyon (DIAB-e CARE)

Lyon, France

Location

CHU de Nîmes - Hôpital Universitaire Caremeau

Nîmes, France

Location

Hopital Lariboisiere & Fernand-Widal

Paris, France

Location

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Bad Oeynhausen, Germany

Location

Zentrum für digitale Diabetologie Hamburg

Hamburg, Germany

Location

Die Praxisgemeinschaft für Endokrinologie und Diabetes

Rostock, Germany

Location

Policlinico Sant' Orsola - Malpighi

Bologna, Italy

Location

Azienda Ospedaliera Ospedale Niguarda Cà Granda

Milan, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli - Università Cattolica del Sacro Cuore

Roma, Italy

Location

ZGT Almelo

Almelo, Netherlands

Location

Amsterdam University Medical Center (Amsterdam UMC)

Amsterdam, Netherlands

Location

Maastricht University Medical Center (UMC)

Maastricht, Netherlands

Location

Hospital Universitari Clínic de Barcelona

Barcelona, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Leicester General Hospital

Leicester, United Kingdom

Location

Manchester University NHS Foundation Trust - Manchester Royal Infirmary

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Helping Behavior; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Social Behavior; Behavior

Study Officials

• Prof. Ohad Cohen, MD

  Medtronic MiniMed, Inc.

  STUDY CHAIR

Central Study Contacts

Jessica Cellot

CONTACT

+393477668604; jessica.cellot@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: February 4, 2026
• First Posted: February 11, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 4, 2027
• Study Completion (Estimated): March 29, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); ES (3); NL (3); FR (5); IT (4); GB (3)