Evaluación de la Precisión del Sistema de Monitoreo de Glucosa Intersticial Basado en Sensores de Abbott
Este estudio tiene como objetivo evaluar la precisión del Sistema de Monitoreo de Glucosa Intersticial Basado en Sensor de Abbott utilizando la Cuadrícula de Error de Consenso, una herramienta para evaluar la precisión clínica en puntos individuales.
Colección de datos
Recopilados desde hoy en adelante - ProspectivoDiabetes Mellitus Tipo 2+5
+ Enfermedades del Sistema Endocrino
+ Enfermedades Autoinmunes
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 1 de febrero de 2014
Fecha en la que se inscribió al primer participante.The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 hours each for venous reference glucose measurements. With every reference measurement, the subject or study staff will perform a measurement on the System.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 75 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: 1. Subject must be at least 18 years of age. 2. Subject must have type 1 or type 2 diabetes for at least 2 years prior to enrollment. 3. Subject must require insulin therapy through an insulin pump and/or multiple daily insulin injections (at least 3 injections daily) for at least 6 months prior to enrollment. 4. Subject must be able to read and understand English. 5. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. 6. Subject must be available to participate in all study visits. 7. Subject must be willing and able to provide written signed and dated informed consent. Exclusion Criteria: 1. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin. 2. Subject is pregnant, attempting to conceive or not willing and able to practice birth control during the study duration (applicable to female subjects only). 3. Subject has skin lesions, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements. 4. Subject currently is participating in another clinical trial. 5. Subject has donated blood within 112 days (3.7 months) prior to the beginning of the study activities. 6. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to: • History of HIV, Hepatitis B or C 7. Subject has a known medical condition that, in the opinion of the investigator, may increase the risk of bleeding. 8. Subject has X-ray, MRI or CT appointment scheduled during the period of study participation, and the appointment cannot be rescheduled for a time before study participation starts or after study participation ends. 9. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 4 ubicaciones
Diablo Clinical Research
Walnut Creek, United StatesAtlanta Diabetes Associates
Atlanta, United StatesRainier Clinical Research Center
Renton, United States