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

Overview

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.

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.

Interventions

• 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).
• 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).

Primary outcome measures

• Primary Endpoint [Time frame: End of 6-month study phase]

Secondary outcome measures (3)

• Secondary Endpoint 1 [Time frame: End of 6-month study phase.]
• Secondary Endpoint 2 [Time frame: End of 6-month study phase.]
• Secondary Endpoints 3 [Time frame: End of 6-month study phase.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Is legally incompetent, illiterate or vulnerable person.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 5 centers

• Centre Hospitalier Universitaire de Caen — Caen
• Hôpital Michallon - CHU Grenoble — Grenoble
• Hospices Civils de Lyon (DIAB-e CARE) — Lyon
• CHU de Nîmes - Hôpital Universitaire Caremeau — Nîmes
• Hopital Lariboisiere & Fernand-Widal — Paris

Italy · 4 centers

• Policlinico Sant' Orsola - Malpighi — Bologna
• Azienda Ospedaliera Ospedale Niguarda Cà Granda — Milan
• Azienda Ospedaliera Universitaria Federico II — Naples
• Fondazione Policlinico Universitario Agostino Gemelli - Università Cattolica del Sacro Cuo — Roma

Germany · 3 centers

• Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum — Bad Oeynhausen
• Zentrum für digitale Diabetologie Hamburg — Hamburg
• Die Praxisgemeinschaft für Endokrinologie und Diabetes — Rostock

Netherlands · 3 centers

• ZGT Almelo — Almelo
• Amsterdam University Medical Center (Amsterdam UMC) — Amsterdam
• Maastricht University Medical Center (UMC) — Maastricht

Spain · 3 centers

• Hospital Universitari Clínic de Barcelona — Barcelona
• Hospital Clínico San Carlos — Madrid
• Hospital Universitario La Paz — Madrid

United Kingdom · 3 centers

• Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital — Cambridge
• Leicester General Hospital — Leicester
• Manchester University NHS Foundation Trust - Manchester Royal Infirmary — Manchester

Identifiers

NCT: NCT07401901 · CIP353

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗