Evaluación de la Seguridad y el Rendimiento del Nuevo Sistema Experimental de Administración Automatizada de Insulina de Medtronic (NMX8) en Personas que Viven con Diabetes (NEXUS) (NEXUS)
Evaluación de la seguridad y el rendimiento del nuevo sistema experimental de administración automatizada de insulina Medtronic (NMX8) en personas que viven con diabetes
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This study is a pre-market, interventional, prospective, open-label, multi-center and randomized controlled clinical study.
The study consists of a run-in phase and a study phase.
Run-in Phase:
The purpose of the run-in phase is to collect baseline CGM data while subjects are on 780G therapy in Auto Mode. All subjects will use the Simplera Sync sensor.
At the end of the run-in phase, subjects will be randomly allocated to one of the two study arms (Treatment arm or Control arm).
Study Phase:
During the 12-week study phase, subjects will either start using the MiniMed™ NMX8 system (Treatment arm) or will continue to use the MiniMed™ 780G in Auto Mode (Control arm). During the study phase, all subjects will use the Simplera™ Sync sensor.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Renée Tillie, PhD
- Número de teléfono: +31627363854
- Correo electrónico: renee.tillie@medtronic.com
Copia de seguridad de contactos de estudio
- Nombre: Bérangère Lacroix
- Número de teléfono: +41797187595
- Correo electrónico: berangere.lacroix@medtronic.com
Ubicaciones de estudio
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Antwerp, Bélgica
- Reclutamiento
- Universitair Ziekenhuis Antwerpen
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Investigador principal:
- Christophe De Block
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Brussels, Bélgica
- Reclutamiento
- Cliniques Universitaires de Bruxelles - Hôpital Erasme
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Investigador principal:
- Laurent Crenier
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Leuven, Bélgica
- Reclutamiento
- UZ Leuven
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Investigador principal:
- Kristina Casteels
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Investigador principal:
- Pieter Gillard
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Aarhus, Dinamarca
- Reclutamiento
- Steno Diabetes Center Aarhus
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Investigador principal:
- Rakel Fuglsang Johansen
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Herlev, Dinamarca
- Reclutamiento
- Steno Diabetes Center Copenhagen
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Investigador principal:
- Kirsten Noergaard
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Ljubljana, Eslovenia
- Reclutamiento
- University Medical Centre Ljubljana
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Investigador principal:
- Klemen Dovc
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Ramat Gan, Israel
- Reclutamiento
- Sheba Medical Center, Edmond and Lily Safra Children's Hospital
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Investigador principal:
- Noah Gruber
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Ramat Gan, Israel
- Reclutamiento
- Sheba Medical Center
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Investigador principal:
- Amir Tirosh
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
- 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.
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.
- 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.
- Subject, Parent(s)/legal guardian (s) are legally incompetent, illiterate, or vulnerable.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Treatment arm (NMX8)
Subjects randomized to the Treatment group will use the MiniMed™ NMX8 system |
Subjects will start using the MiniMed™ NMX8 system for 12 weeks |
|
Comparador activo: Control arm (780G)
Subjects randomized to the Control arm will continue to use the MiniMed™ 780G. |
Subjects will continue to use the MiniMed™ 780G for 12 weeks |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Primary Endpoint
Periodo de tiempo: During the 12-week study phase
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Secondary Endpoint 1
Periodo de tiempo: End of 12-week Study Phase
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The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with a non-inferiority testing. |
End of 12-week Study Phase
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Secondary endpoint 2
Periodo de tiempo: During the 12-week Study Phase
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The between-treatment (NMX8 system arm versus 780Gm system arm) difference in % of Time spent in target range (70 to 180 mg/dL [3.9 - 10.0 mmol/L]) during the study phase with superiority test. |
During the 12-week Study Phase
|
|
Secondary Endpoint 3
Periodo de tiempo: End of the 12-week Study Phase
|
The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with superiority testing. |
End of the 12-week Study Phase
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Pr. Ohad Cohen, MD, Medtronic MiniMed, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CIP352
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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