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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes (T1D)
• Intervention / Treatment: Device: NMX8 System - Treatment arm; Device: AID Therapy; Device: NMX8 System - Control Arm

Detailed Description

ELEVATE is a pre-market, interventional, prospective, open-label, multi-center, randomized controlled study that consists of three phases: run-in, study and continuation phase.

Run-in: the purpose of this phase is to collect 3 weeks of blinded Continuous Glucose Monitoring (CGM) data while subjects are on their current therapy (baseline assessment). All subjects will use an additional blinded Simplera Sensor to collect blinded CGM data.

Study Phase: during the 6-month of study phase subjects will either start using the NMX8 system (Treatment arm) or will continue to use their current AID therapy (Control arm). Subjects in the Control arm will undergo 3 weeks of blinded CGM data collection via Simplera Sensor at 3 and 6 months.

Continuation Phase: during the 3-month of continuation phase all subjects will use the NMX8 system.

Approximately 230 subjects will be enrolled in the study up to approximately 22 investigational centers in EMEA.

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Cellot; Phone Number: +393477668604; Email: jessica.cellot@medtronic.com

Study Locations

• France
  • Caen, France
    • Centre Hospitalier Universitaire de Caen
  • Grenoble, France
    • Hôpital Michallon - CHU Grenoble
  • Lyon, France
    • Hospices Civils de Lyon (DIAB-e CARE)
  • Nîmes, France
    • CHU de Nimes - Hopital Universitaire Caremeau
  • Paris, France
    • Hopital Lariboisiere & Fernand-Widal
• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
  • Hamburg, Germany
    • Zentrum für digitale Diabetologie Hamburg
  • Rostock, Germany
    • Die Praxisgemeinschaft für Endokrinologie und Diabetes
• Italy
  • Bologna, Italy
    • Policlinico Sant' Orsola - Malpighi
  • Milan, Italy
    • Azienda Ospedaliera Ospedale Niguarda Ca Granda
  • Naples, Italy
    • Azienda Ospedaliera Universitaria Federico II
  • Roma, Italy
    • Fondazione Policlinico Universitario Agostino Gemelli - Università Cattolica del Sacro Cuore
• Netherlands
  • Almelo, Netherlands
    • ZGT Almelo
  • Amsterdam, Netherlands
    • Amsterdam University Medical Center (Amsterdam UMC)
  • Maastricht, Netherlands
    • Maastricht University Medical Center (UMC)
• Spain
  • Barcelona, Spain
    • Hospital Universitari Clínic de Barcelona
  • Madrid, Spain
    • Hospital Clinico San Carlos
  • Madrid, Spain
    • Hospital Universitario La Paz
• United Kingdom
  • Cambridge, United Kingdom
    • Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
  • Leicester, United Kingdom
    • Leicester General Hospital
  • Manchester, United Kingdom
    • Manchester University NHS Foundation Trust - Manchester Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Is aged ≥ 18 years old at time of screening.
2. 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.
3. Is on commercially approved AID therapy (e.g. MiniMed 780G, Control IQ, OmniPod 5, CamAPS FX) for at least 3 months before screening.
4. 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).
5. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units.
6. 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).
7. Is willing to switch to an approved insulin per insulin pump labeling.
8. Is willing to participate in all training sessions as directed by study staff.
9. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol.
10. Subject is willing and able to provide written informed consent.

Exclusion Criteria:

1. Has untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
2. 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).
3. 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.
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 any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
6. Has active or severe retinopathy in the last 6 months before the screening.
7. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.

8. 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.

9. History of 2 or more DKA events in the last 3 months before screening.
10. Is on "DIY" therapy at the time of the screening or at least 3 months before the screening.
11. 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.
12. 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.
13. Is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
14. Is part of the research staff involved with the study.
15. Is legally incompetent, illiterate or vulnerable person.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm (NMX8 system); Subjects randomized to the Treatment group will use the MiniMed NMX8 system	Device: NMX8 System - Treatment arm; Subjects start using the NMX8 system after the run-in phase and continue through both study (6-month) and continuation phases (3-month).
Active Comparator: Control arm (AID Therapy); 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; Subjects will continue to use their current AID therapy during the study phase (6-month).; Device: NMX8 System - Control Arm; Subjects start using the NMX8 system during the continuation phases (3-month).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint 1	The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in HbA1c (%) at the end of the study phase. The endpoint will be assessed for non-inferiority.	End of 6-month study phase.
Secondary Endpoint 2	The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in HbA1c (%) at the end of the study phase. The endpoint will be assessed for superiority.	End of 6-month study phase.
Secondary Endpoints 3	The between-treatment difference (control arm using AID system vs treatment arm using the NMX8 system) in the percentage of time spent in 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 superiority.	End of 6-month study phase.

Collaborators and Investigators

• Sponsor: Medtronic MiniMed, Inc.
• Investigators: Study Chair: Prof. Ohad Cohen, MD, Medtronic MiniMed, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): December 4, 2027
• Study Completion (Estimated): March 29, 2028

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Automated insulin delivery (AID); Diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Behavior; Nutritional and Metabolic Diseases; Social Behavior; Diabetes Mellitus; Diabetes Mellitus, Type 1; Helping Behavior
• Other Study ID Numbers: CIP353

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