IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT02647905 (PRECISEII) para Diabetes mellitus está completado. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un estudio coincide con los criterios de filtro
Vista de tarjeta
Evaluation of the Accuracy of an Implanted Glucose Sensor (PRECISEII) 90
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT02647905 (PRECISEII) fue un estudio intervencionista para Diabetes mellitus. Su estado actual es: completado. El estudio se inició el 1 de enero de 2016, con el objetivo de reclutar a 90 participantes. Dirigido por Senseonics, Inc., la fecha de finalización prevista fue el 1 de julio de 2016. Los datos se actualizaron por última vez en ClinicalTrials.gov el 6 de junio de 2018.
Resumen
The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.
Título oficial
A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor, PRECISE II
Condiciones médicas
Diabetes mellitusOtros ID del estudio
- PRECISEII
- CTP-0023
Número del NCT
Inicio del estudio (real)
2016-01
Última actualización
2018-06-06
Fecha de finalización (estimada)
2016-07
Inscripción (prevista)
90
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Completado
Palabras clave
type 1 diabetes
type 2 diabetes
CGM
implantable
accuracy
longevity
type 2 diabetes
CGM
implantable
accuracy
longevity
Objetivo principal
Diagnóstico
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalAccuracy assessment, CGMS To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days | Continuous Glucose Monitoring System Accuracy and safety assessment of a continuous glucose monitoring device |
Resultado primario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
CGM Relative Difference to Laboratory Reference Reported as MARD | Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison. | 90 days |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Adult subjects, age ≥18 years
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form and is willing to comply with protocol requirements
- History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
- A condition preventing or complicating the placement, operation, or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition.
- Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e,g, CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.
- Hematocrit <30% or >55%
- History of hepatitis B, hepatitis C, or HIV
- Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study.
Senseonics, Inc.No hay datos de contacto.
9 Centros del estudio en 1 países
California
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States
AMCR Institute, Escondido, California, 92025, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Georgia
Atlanta Diabetes Care, Atlanta, Georgia, 30318, United States
New York
Mount Sinai Diabetes Center, New York, New York, 10029, United States
Texas
Worldwide Clinical Trials, San Antonio, Texas, 78217, United States
Clinical Trials of Texas, San Antonio, Texas, 78229, United States
Virginia
UVA Diabetes and Endocrine Clinic, Charlottesville, Virginia, 22903, United States
Washington
Rainier Clinical Research, Renton, Washington, 98057, United States