{"id":53262,"date":"2023-01-24T23:02:15","date_gmt":"2023-01-24T22:02:15","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/tidepool-announces-fda-clearance-of-tidepool-loop\/"},"modified":"2023-01-24T23:02:15","modified_gmt":"2023-01-24T22:02:15","slug":"tidepool-announces-fda-clearance-of-tidepool-loop","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/tidepool-announces-fda-clearance-of-tidepool-loop\/","title":{"rendered":"Tidepool Announces FDA Clearance of Tidepool Loop"},"content":{"rendered":"
\n

\nOpen Source Diabetes Nonprofit Brings Community-Led Innovation in the Form of the First iPhone-Controlled Interoperable Automated Glycemic Controller for Type 1 Diabetes Management\n<\/p>\n

PALO ALTO, Calif.–(BUSINESS WIRE)–#diabetes<\/a>–Tidepool, a 501(c)3 nonprofit committed to empowering the next generation of innovations in diabetes management, today announced the FDA clearance of Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in persons six years of age and greater.\n<\/p>\n

<\/a><\/p>\n

\nTidepool Loop, a patient-led project, is the first application of its kind to receive clearance from the FDA, and is also the first to enable insulin delivery from a compatible Apple Watch. The algorithm technology in Tidepool Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend and deliver correction boluses when glucose values are predicted to exceed predefined thresholds.\n<\/p>\n

\n\u201cWe knew this day would come, but we couldn\u2019t have achieved it without the support of the entire diabetes community, including the FDA,\u201d said Howard Look, CEO and co-founder of Tidepool. \u201cI\u2019d also like to personally acknowledge and celebrate the contributions of the DIY community and participants in the Loop Observational Study conducted by the JAEB Center for Health Research who made this milestone possible.\u201d\n<\/p>\n

\nTidepool Loop can now serve as a predicate device for future interoperable Automated Insulin Dosing (AID) submissions, providing a more clearly defined pathway through the regulatory process. This work was supported by grants from JDRF<\/a>, The Helmsley Charitable Trust<\/a>, the Tullman Foundation, and a diverse community of individual funders impacted by their experience with diabetes.\n<\/p>\n

\n\u201cTidepool helped bridge the gap between the fast pace of innovation in the community and the rigor of current quality management systems. This is a triumph for stakeholders across the diabetes industry, and most importantly, will make a real impact in the lives of people with diabetes,\u201d said David Panzirer, Trustee at The Leona M. and Harry B. Helmsley Charitable Trust.\n<\/p>\n

\n\u201cTidepool Loop\u2019s groundbreaking FDA clearance represents a pivotal step towards a world where people with T1D can choose the pump, CGM, and algorithm that are best for them\u2014and have all three work together,\u201d said Aaron Kowalski, CEO of JDRF. \u201cIt\u2019s also a testament to the innovation, commitment, and spirit of the T1D community. We look forward to continuing to work with Tidepool to make open protocol a reality, and we anxiously await news on future AID systems that will utilize this tremendous platform.\u201d\n<\/p>\n

\nWith the clearance of Tidepool Loop, the organization is now finalizing agreements with device partners to create a seamless experience for both physicians prescribing Tidepool Loop and the patients using it. Though Tidepool’s initial launch device partners have not been announced, the company has a development partnership with Dexcom<\/a> (DXCM) and additional yet-to-be-named medical device companies for future inclusion of their components with the Tidepool Loop platform.\n<\/p>\n

\nAbout Tidepool<\/b>\n<\/p>\n

\nTidepool is a 501(c)3 nonprofit organization on a mission to make diabetes data more accessible, actionable, and meaningful for people with diabetes, their care teams, and researchers. Founded in 2013, Tidepool hosts a suite of software tools for people with diabetes and the clinics that serve them, including Tidepool Web, Tidepool Mobile, Tidepool Uploader, and soon Tidepool Loop. Learn more at tidepool.org<\/a>. Follow us on Twitter at @Tidepool_org<\/a> and on Facebook<\/a> and Instagram<\/a>.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nChristopher Snider
\n
Saira Khan-Gallo
\n
media@tidepool.org<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Open Source Diabetes Nonprofit Brings Community-Led Innovation in the Form of the First iPhone-Controlled Interoperable Automated Glycemic Controller for Type 1 Diabetes Management PALO ALTO, Calif.–(BUSINESS WIRE)–#diabetes–Tidepool, a 501(c)3 nonprofit committed to empowering the next generation of innovations in diabetes management, today announced the FDA clearance of Tidepool Loop, an automated insulin dosing app intended … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-53262","6":"format-standard","7":"category-industry"},"yoast_head":"\nTidepool Announces FDA Clearance of Tidepool Loop - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/tidepool-announces-fda-clearance-of-tidepool-loop\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Tidepool Announces FDA Clearance of Tidepool Loop - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Open Source Diabetes Nonprofit Brings Community-Led Innovation in the Form of the First iPhone-Controlled Interoperable Automated Glycemic Controller for Type 1 Diabetes Management PALO ALTO, Calif.–(BUSINESS WIRE)–#diabetes–Tidepool, a 501(c)3 nonprofit committed to empowering the next generation of innovations in diabetes management, today announced the FDA clearance of Tidepool Loop, an automated insulin dosing app intended ... 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