{"id":25688,"date":"2012-03-20T04:48:12","date_gmt":"2012-03-20T08:48:12","guid":{"rendered":"http:\/\/asweetlife.org\/?p=25688"},"modified":"2015-12-30T03:21:01","modified_gmt":"2015-12-30T08:21:01","slug":"first-us-artificial-pancreas-outpatient-trial-approved-by-fda","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=25688","title":{"rendered":"First US Artificial Pancreas Outpatient Trial Approved by FDA"},"content":{"rendered":"<div style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/JDRF-New-Logo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-25691 lazyload\" title=\"JDRF New Logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/JDRF-New-Logo.jpg\" alt=\"\" width=\"200\" height=\"97\" \/><\/a>The U.S. Food and Drug Administration (FDA) has approved the first outpatient artificial pancreas trial in the United States, marking a critical development in the effort by JDRF and its allies to bring this innovative and lifesaving diabetes technology to people with type 1 diabetes.<\/div>\n<div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">The JDRF-funded study will test an artificial pancreas system&#8217;s ability to function outside of a hospital setting, and is similar to the current outpatient trials being conducted in Europe. \u00a0<\/div>\n<div style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/APP.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"size-medium wp-image-25690 alignright lazyload\" title=\"Artificial Pancreas\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/APP-300x201.jpg\" alt=\"Artificial Pancreas\" width=\"210\" height=\"141\" data-sizes=\"auto\" data-srcset=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/APP-300x201.jpg 300w, https:\/\/asweetlife.org\/wp-content\/uploads\/2012\/03\/APP.jpg 471w\" sizes=\"(max-width: 210px) 100vw, 210px\" \/><\/a>\u00a0<\/div>\n<div style=\"text-align: justify;\">The study is part of the first outpatient trials using an approach developed by the JDRF-supported Artificial Pancreas Consortium, an international research group including teams from Montpellier University Hospital (France), the Universities of Padova and Pavia (Italy), and the Universities of Virginia in Charlottesville and of California in Santa Barbara (USA).<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">The approval of this milestone study follows a major 18-month long effort by JDRF and allies to ensure a clear and reasonable regulatory pathway for outpatient artificial pancreas studies, and ultimately for\u00a0 artificial pancreas\u00a0systems to be approved and made available by the FDA. JDRF-funded studies have shown improved clinical outcomes from early trials of prototype\u00a0 artificial pancreas\u00a0systems. \u00a0In early 2011, JDRF proposed guidance to the FDA, based on recommendations from an external expert panel. \u00a0In the following months, over 100,000 people in the diabetes community signed JDRF&#8217;s petition, and numerous leading clinical organizations, as well as over 60 Senators and 250 Representatives joined JDRF in urging FDA to act. The FDA met its promised deadline and released draft guidance for\u00a0 artificial pancreas\u00a0systems on December 1, 2011.\u00a0<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">JDRF recently completed an evaluation of the draft FDA\u00a0 artificial pancreas\u00a0guidance, and submitted comments to FDA on March 3rd. \u00a0JDRF believes that the draft contains many positive elements that will encourage research and development of artificial pancreas technologies and lead to their eventual availability in the U.S.<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">The development of an artificial pancreas is one of JDRF&#8217;s top priorities. JDRF and the National Institutes of Health&#8217;s Special Diabetes Program have funded groundbreaking work in recent years to advance its research and development.<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) has approved the first outpatient artificial pancreas trial in the United States, marking a critical development in the effort by JDRF and its allies to bring this innovative and lifesaving diabetes technology to people with type 1 diabetes&#8230;<\/p>\n","protected":false},"author":131,"featured_media":25691,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1448],"tags":[415,135,287],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>First US Artificial Pancreas Outpatient Trial Approved by FDA<\/title>\n<meta name=\"description\" content=\"The U.S.FDA approved the first outpatient artificial pancreas trial in the United States, marking a 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