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Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes

12 de noviembre de 2026 actualizado por: Medtronic MiniMed, Inc.

This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The study is a multi-center, prospective single-arm design without controls for adult and pediatric subjects with T1D or T2D. The study is anticipated to last approximately 24 months from first investigational center initiation to study completion (last subject, last visit completed). The subject's participation from study enrollment to study exit is approximately up to 46 days (including replacement sensor wear and repeat office procedures if needed).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1500

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Chula Vista, California, Estados Unidos, 91911
      • Escondido, California, Estados Unidos, 92025-6428
      • Palo Alto, California, Estados Unidos, 94304
        • Aún no reclutando
        • Stanford University
        • Contacto:
        • Investigador principal:
          • Rayhan Lal
      • San Diego, California, Estados Unidos, 92123
        • Aún no reclutando
        • Rady Children's Hospital - San Diego
        • Contacto:
          • Carla Logan
          • Número de teléfono: 858-966-8400
          • Correo electrónico: Clogan1@rchsd.org
        • Investigador principal:
          • Anna Cymbaluk
      • San Francisco, California, Estados Unidos, 94158
        • Aún no reclutando
        • University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes
        • Contacto:
        • Investigador principal:
          • Laya Ekhlaspour
      • Santa Barbara, California, Estados Unidos, 93105
        • Reclutamiento
        • Sansum Diabetes Research Institute
        • Contacto:
        • Investigador principal:
          • Andrew Rhinehart
      • Walnut Creek, California, Estados Unidos, 94598
        • Reclutamiento
        • Diablo Clinical Research, Inc.
        • Investigador principal:
          • Mark Christiansen
        • Contacto:
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Reclutamiento
        • Barbara Davis Center for Diabetes
        • Investigador principal:
          • Gregory Forlenza
        • Investigador principal:
          • Satish Garg
        • Contacto:
        • Contacto:
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06511
        • Aún no reclutando
        • Yale University School of Medicine
        • Contacto:
        • Investigador principal:
          • Laura Nally
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • Aún no reclutando
        • University of Florida
        • Contacto:
        • Investigador principal:
          • Michael Haller
      • Tampa, Florida, Estados Unidos, 33612
        • Aún no reclutando
        • University of South Florida (USF) Diabetes and Endocrinology Center
        • Contacto:
          • Elizabeth Doble
          • Número de teléfono: 813-974-5529
          • Correo electrónico: edoble@usf.edu
        • Investigador principal:
          • Dorothy Shulman
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30318
        • Reclutamiento
        • Atlanta Diabetes Associates
        • Investigador principal:
          • Bruce Bode
        • Contacto:
    • Idaho
      • Idaho Falls, Idaho, Estados Unidos, 83404
    • Texas
      • Austin, Texas, Estados Unidos, 78749
        • Reclutamiento
        • Texas Diabetes and Endocrinology
        • Contacto:
        • Investigador principal:
          • Lindsay Harrison
      • San Antonio, Texas, Estados Unidos, 78240
        • Reclutamiento
        • Diabetes and Glandular Disease Clinic
        • Investigador principal:
          • Mark Kipnes
        • Contacto:
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22903
        • Reclutamiento
        • University of Virginia Health System
        • Contacto:
        • Investigador principal:
          • Mark DeBoer
    • Washington
      • Renton, Washington, Estados Unidos, 98057
        • Reclutamiento
        • Rainier Clinical Research Center
        • Investigador principal:
          • Sheryl Marks
        • Contacto:
      • Seattle, Washington, Estados Unidos, 98105
        • Aún no reclutando
        • Seattle Children's
        • Contacto:
        • Investigador principal:
          • Catherine Pihoker

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

2 años a 80 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Age 2-80 years at time of screening.

  2. Has a clinical diagnosis of diabetes as stipulated according to the following age group:

    1. Age 2-10 years: Has a clinical diagnosis of T1D or T2D as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
    2. Age 11-80 years: Has a clinical diagnosis of T1D or T2D for 6 months or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.

  3. Subject or parent(s)/ guardian(s)/ caregiver(s) is/are literate and able to read the language offered in the study materials.

  4. Is willing to provide informed consent/assent for participation.

  5. If participating in BGA FST, has adequate venous access as assessed by investigator or appropriate staff.

  6. Is willing to perform fingerstick blood glucose measurements as needed.

  7. Is willing to wear the study devices continuously throughout the study.

  8. Subject or parent(s)/guardian(s)/caregiver(s) is/are willing to complete the requirements for diary data entry, as applicable.

  9. If participating in glycemic challenges, has met the following conditions:

    1. Been using insulin for at least 3 months
    2. A relatively stable insulin-to-carbohydrate ratio(s) and insulin sensitivity factor(s) for at least one month per investigator assessment Subjects who do not meet the above conditions can be included in the study, however, will participate in the FST under observation only (no glycemic challenges).

Exclusion Criteria:

  1. Unable to consent due to a mental or intellectual disability.

  2. Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.

  3. Has had a hypoglycemic seizure within the past 6 months prior to screening visit.

  4. Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.

  5. Has a history of 1 or more episodes of DKA in the last 6 months prior to screening visit.

  6. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.

  7. Has a history of a seizure disorder.

  8. Has a central nervous system or cardiac disorder resulting in syncope.

  9. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.

  10. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

  11. Currently pregnant or planning to become pregnant during the time period of study participation

    1. A negative pregnancy test will be required for all females of child-bearing potential at time of screening
    2. For sexually active females of child-bearing potential the investigator will use discretion to determine if the form of contraception that is being used is reliable

  12. Has diagnosis of adrenal insufficiency.

  13. Is using hydroxyurea at time of screening or plans to use it during the study.

  14. Is participating in another pharmaceutical or device trial within 2 weeks of enrollment or anticipates participation in another trial during the course of the study. (Please note participation in an observational study is acceptable.)

  15. Has a planned procedure involving the use of a Magnetic Resonance Imaging (MRI), diathermy devices, or other devices that generate strong magnetic fields (e.g., x-ray, CT scan, or other types of radiation) during the study wear period.

  16. Has elective surgery planned that requires general anesthesia during the course of the study.

  17. T2D: Is using insulin secretagogue.

  18. Is, at the discretion of the investigator, abusing drugs or alcohol

  19. Age 7-80 years: has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that prior blood draw from routine care may be used as long as the prior blood draw was done within 3 months prior to screening and report of lab placed with subject source documents).

  20. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.

  21. Has had any of the following cardiovascular events more than 1 year prior to screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. However, subject may participate at the discretion of the investigator and with clearance from the cardiologist.

  22. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.

  23. Is a member of the research staff involved with the study.

  24. Is a sponsor employee or their immediate family member (excluding adult children and/or adult siblings).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Next Generation Extended Wear Sensors

All subjects will wear the sensor. Each subject and subject's parent/guardian/caregiver (if applicable) may insert and tape (if applicable) the study glucose sensors once trained or have them inserted and taped (if applicable) by the trained investigational center staff.
Dispositivo: Next Generation Extended Wear Sensors

Disposable Sensor (MMT-5600XNG and MMT-5600X) - labeled as DS5K and referred to as Unity

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Primary Safety Endpoints
Periodo de tiempo: Approximately up to 46 days

Descriptive summary will be used to characterize:

  • Skin assessment of subject's glucose sensor insertion sites

  • Adverse events (AE) to include:

    • Serious Adverse Events (SAE)
    • Device Related AEs
    • Procedure Related AEs
    • Serious Adverse Device Effects (SADE)
    • Unanticipated Adverse Device Effects (UADE)
    • Severe hypoglycemia
    • Diabetic Ketoacidosis (DKA)
    • Hyperosmolar Hyperglycemic State (HHS)
Approximately up to 46 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Medtronic MiniMed, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de octubre de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

28 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de octubre de 2026

Publicado por primera vez (Actual)

7 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CIP358

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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