{"id":24532,"date":"2022-03-28T08:44:50","date_gmt":"2022-03-28T14:44:50","guid":{"rendered":"https:\/\/saluddigital.com\/?p=24532"},"modified":"2025-10-21T10:04:38","modified_gmt":"2025-10-21T16:04:38","slug":"dispositivo-que-monitorea-constantemente-la-glucosa-en-adultos-recibe-aprobacion-de-la-fda","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/noticias\/dispositivo-que-monitorea-constantemente-la-glucosa-en-adultos-recibe-aprobacion-de-la-fda\/","title":{"rendered":"Device That Continuously Monitors Glucose in Adults Receives FDA Approval"},"content":{"rendered":"
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A sensor for glucose monitoring in adults with diabetes with the ability to function for up to six months has received approval from the US Food and Drug Administration (FDA).<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The continuous glucose monitoring system developed by the Senseonics company received FDA approval to market its Eversense E3 product. This device is implanted in the body of adults with diabetes and monitors their glucose for up to six months.<\/p>

The implantable device is about the size of a fingernail and, according to the FDA, \u201cprovides real-time blood sugar (glucose) readings every five minutes for people with diabetes. The system consists of an implantable fluorescence-based sensor, a transmitter, and a mobile app to display glucose values, trends, and alerts on the patient's compatible mobile device."<\/p>

The device must be implanted by a medical professional as it is inserted under the skin. Through bluetooth, it completely wirelessly sends glucose data to a mobile device. In addition, the Eversense mobile app alerts the user in the event of hyperglycemia or hypoglycemia, according to the levels configured by the patient.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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The FDA also explains the importance of the system's data collection as it "can track long-term trends in glucose measurements and help patients and their providers make adjustments to treatment plans over time to maintain blood glucose levels in a safe range.<\/p>

After Senseonics' application to the FDA was postponed due to the pandemic, they have finally received the yes, in order to provide their services to patients living with diabetes.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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The medical director of Senseonics explained in a statement that this system is a great advance for the control and monitoring of diabetes in adults. Likewise, he thanked the researchers of the PROMISE study, and their participants, who were a vital part in achieving the development of the system. \u201cWe are excited to start making this next-generation product available in the US for people with diabetes,\u201d he explained.<\/p>

On the other hand, the American company has also announced that it will seek to carry out tests to develop a similar device, but that it extends its use for up to a year.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t BIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

FDA<\/strong><\/p>

https:\/\/www.fda.gov\/medical-devices\/eversense-e3-continuous-glucose-monitoring-system-p160048s016<\/a><\/p>

MOBIHEALTH NEWS<\/strong><\/p>

https:\/\/www.mobihealthnews.com\/news\/senseonics-scores-fda-approval-eversense-e3-cgm-implantable-sensor<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Un sensor para el monitoreo de la glucosa en adultos con diabetes con capacidad de funcionar hasta seis meses ha recibido la aprobaci\u00f3n de la Administraci\u00f3n de Alimentos y Medicamentos (FDA) de EE.UU. El sistema de monitoreo continuo de glucosa desarrollado por la compa\u00f1\u00eda Senseonics, recibi\u00f3 la aprobaci\u00f3n de la FDA para comercializar su producto Eversense E3. Este dispositivo se implanta en el cuerpo de adultos con diabetes y monitorea hasta por seis meses su glucosa. El dispositivo implantable tiene un tama\u00f1o aproximado de una u\u00f1a y seg\u00fan explica la FDA: \u201cbrinda lecturas de az\u00facar en la sangre (glucosa) en tiempo real cada cinco minutos para las personas con diabetes. El sistema consta de un sensor implantable basado en fluorescencia, un transmisor y una aplicaci\u00f3n m\u00f3vil para mostrar valores de glucosa, tendencias y alertas en el dispositivo m\u00f3vil compatible del paciente\u201d. El dispositivo debe ser implantado por un profesional m\u00e9dico ya que se inserta por debajo de la piel.  A trav\u00e9s de bluetooth, de forma totalmente inal\u00e1mbrica env\u00eda los datos de la glucosa a un dispositivo m\u00f3vil.  Adem\u00e1s, la app m\u00f3vil de Eversense alerta al usuario en caso de hiperglucemias o hipoglucemias, seg\u00fan los niveles configurados por el paciente. La FDA tambi\u00e9n explica la importancia de la recopilaci\u00f3n de datos del sistema ya que \u201cpueden rastrear tendencias a largo plazo en las mediciones de glucosa y ayudar a los pacientes y sus proveedores a realizar ajustes en los planes de tratamiento a lo largo del tiempo para mantener los niveles de glucosa en sangre en un rango seguro\u201d. Luego de que la solicitud de Senseonics ante la FDA fuera aplazada debido a la pandemia, finalmente han recibido el s\u00ed, para poder brindar sus servicios a pacientes que viven con diabetes. La directora m\u00e9dica de Senseonics, explic\u00f3 en un comunicado que este sistema es un gran avance para el control y monitoreo de la diabetes en adultos. Asimismo, agradeci\u00f3 a los investigadores del estudio PROMISE, y a sus participantes, que fueron parte vital para alcanzar el desarrollo del sistema. \u201cEstamos entusiasmados de comenzar a fabricar este producto de pr\u00f3xima generaci\u00f3n disponible en los EE. UU. para las personas con diabetes\u201d, explic\u00f3. Por otra parte, la compa\u00f1\u00eda estadounidense tambi\u00e9n ha anunciado que buscar\u00e1 realizar pruebas para desarrollar un dispositivo similar, pero que extiende su uso hasta por un a\u00f1o. BIBLIOGRAF\u00cdA FDA https:\/\/www.fda.gov\/medical-devices\/eversense-e3-continuous-glucose-monitoring-system-p160048s016 MOBIHEALTH NEWS https:\/\/www.mobihealthnews.com\/news\/senseonics-scores-fda-approval-eversense-e3-cgm-implantable-sensor<\/p>","protected":false},"author":1,"featured_media":24534,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3395,3393,160],"tags":[145],"class_list":["post-24532","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-apps-moviles-e-internet-de-las-cosas","category-inteligencia-artificial-y-ciencia","category-noticias","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/24532","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/comments?post=24532"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/24532\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/24534"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=24532"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=24532"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=24532"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}