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Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System (STRIVE 2)

28 de mayo de 2026 actualizado por: Insulet Corporation

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia

This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5.

After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses

Tipo de estudio

Intervencionista

Inscripción (Estimado)

200

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

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90022
        • Aún no reclutando
        • University of Southern California
        • Contacto:
          • Martha Walker
          • Número de teléfono: 323-605-4442
          • Correo electrónico: mawalker@usc.edu
        • Investigador principal:
          • Anne Peters
      • Santa Barbara, California, Estados Unidos, 93105
        • Reclutamiento
        • Sansum Diabetes Research Institute
        • Investigador principal:
          • Kristin Castorino
        • Contacto:
          • Juliana Lopez
          • Número de teléfono: 8057059465
          • Correo electrónico: jlopez@sansum.org
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Aún no reclutando
        • University of Colorado
        • Investigador principal:
          • Gregory Forlenza
        • Contacto:
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06511
        • Aún no reclutando
        • Yale
        • Contacto:
        • Investigador principal:
          • Amy Steffen
    • Florida
      • Tampa, Florida, Estados Unidos, 33612
        • Aún no reclutando
        • University of South Florida
        • Contacto:
        • Investigador principal:
          • Dorothy Shulman
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
        • Aún no reclutando
        • Emory University
        • Contacto:
          • Sabeena Usman
        • Investigador principal:
          • Georgia Davis
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Aún no reclutando
        • Northwestern University
        • Investigador principal:
          • Grazia Aleppo
        • Contacto:
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Aún no reclutando
        • Indiana University
        • Investigador principal:
          • Viral Shah
        • Contacto:
          • Kathy Bohanan
          • Número de teléfono: 317-278-0651
          • Correo electrónico: kkremer@iu.edu
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Reclutamiento
        • Joslin Diabetes Center
        • Investigador principal:
          • Lori Laffel
        • Contacto:
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Reclutamiento
        • Henry Ford Health Systems
        • Investigador principal:
          • Davida Kruger
        • Contacto:
          • Lydia Oehring
          • Número de teléfono: +1 (313) 916-3906
          • Correo electrónico: loehrin1@hfhs.org
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55416
        • Reclutamiento
        • Health Partners
        • Contacto:
        • Investigador principal:
          • Amy Criego
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Aún no reclutando
        • Baylor College of Medicine
        • Contacto:
        • Investigador principal:
          • Daniel DeSalvo

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age at time of consent 14-75 years (inclusive)
  • Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment
  • Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation
  • HbA1c ≥ 7.5%
  • Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user
  • Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user
  • Currently using a continuous glucose monitor
  • Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents.
  • Participant agrees to provide their own insulin for the duration of the study
  • Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
  • Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
  • If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
  • Willing to wear the system continuously throughout the study
  • Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged < 18 years per local regulatory requirements
  • Able to read and understand English and operate the study device in English
  • If of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

  • Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
  • Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
  • Any planned surgery during the study which could be considered major in the judgment of the investigator
  • History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
  • History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
  • Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
  • Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
  • Use of hydroxyurea
  • Plans to receive blood transfusion over the course of the study
  • Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
  • Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.
  • Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening
  • Pregnant or lactating, or of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner).
  • Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period
  • Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment
  • Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Omnipod 5 System
Dispositivo: Omnipod 5 System
The Omnipod 5 System with the study CGM
Experimental: Omnipod 6 System
Dispositivo: Omnipod 6 System
The Omnipod 6 System with the study CGM

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time in Range 70-180 mg/dL
Periodo de tiempo: 13 weeks
Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <54 mg/dL
Periodo de tiempo: 13 weeks
Change in CGM percent time <54 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <70 mg/dL
Periodo de tiempo: 13 weeks
Change in CGM percent time <70 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >180 mg/dL
Periodo de tiempo: 13 weeks
Change in CGM percent time >180 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time in Range 70-140 mg/dL
Periodo de tiempo: 13 weeks
Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
HbA1c
Periodo de tiempo: 13 weeks
Change in HbA1c (%) between Omnipod 6 and Omnipod 5
13 weeks
Mean sensor glucose
Periodo de tiempo: 13 weeks
Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >250 mg/dL
Periodo de tiempo: 13 weeks
Change in CGM percent time >250 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total boluses per day
Periodo de tiempo: 13 weeks
Total blues per day will be compared between Omnipod 6 and Omnipod 5
13 weeks
Total daily insulin per kg and total insulin delivered via automation
Periodo de tiempo: 13 weeks
Total daily insulin per kg and total insulin delivered via automation will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage of time in automated mode
Periodo de tiempo: 13 weeks
Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with HbA1c <7.0% and <7.5%
Periodo de tiempo: 13 weeks
Percentage with HbA1c <7.0% and <7.5% will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with >= 70% time in range
Periodo de tiempo: 13 weeks
Percentage with >= 70% time in range will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with >= 50% time in range
Periodo de tiempo: 13 weeks
Percentage with >= 50% time in range will be compared between Omnipod 6 and Omnipod 5
13 weeks
Diabetes treatment satisfaction
Periodo de tiempo: 13 weeks
Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6
13 weeks
System Usability
Periodo de tiempo: 13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
System Opinion
Periodo de tiempo: 13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
Health Related Quality of Life (HR-QOL)
Periodo de tiempo: 13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Hypoglycemia confidence
Periodo de tiempo: 13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Missed Meal - Peak glucose
Periodo de tiempo: 13 weeks
Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - AUC
Periodo de tiempo: 13 weeks
AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Time in Range
Periodo de tiempo: 13 weeks
Time in Range 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time > 180 mg/dL
Periodo de tiempo: 13 weeks
Percentage of Time > 180 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time > 250 mg/dL
Periodo de tiempo: 13 weeks
Percentage of Time > 250 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time <54 mg/dL
Periodo de tiempo: 13 weeks
Percentage of Time <54 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time <70 mg/dL
Periodo de tiempo: 13 weeks
Percentage of Time <70 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Number of severe hypoglycemic events
Periodo de tiempo: 13 weeks
13 weeks
Number of DKA or HHS events
Periodo de tiempo: 13 weeks
13 weeks
Other related serious adverse events
Periodo de tiempo: 13 weeks
13 weeks
Unanticipated adverse device effects
Periodo de tiempo: 13 weeks
13 weeks
Reportable device-related adverse events
Periodo de tiempo: 13 weeks
13 weeks

Colaboradores e Investigadores

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

Patrocinador

Insulet Corporation

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)

13 de mayo de 2026

Finalización primaria (Estimado)

1 de febrero de 2027

Finalización del estudio (Estimado)

1 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

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

28 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STRIVE 2

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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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