{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T07:33:11Z","timestamp":1793172791060,"version":"4.5.0"},"reference-count":117,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T00:00:00Z","timestamp":1791504000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T00:00:00Z","timestamp":1791504000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Breakthrough T1D"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Technology &amp; Therapeutics"],"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>Current commercially available automated insulin delivery systems require meal and exercise announcements for optimal function, placing them in the hybrid closed loop category. Ongoing advancements aim to establish fully closed loop (FCL) systems as the next-generation standard for type 1 diabetes (T1D) management, eliminating the need for such inputs. We sought to develop a shared definition of FCL so that emerging technologies, including those using artificial intelligence, multi-hormone delivery, multi-analyte sensing, and\/or adjunctive therapies, are held to uniform performance standards.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A group of invited experts, including clinicians, researchers, and people with lived experience convened to propose an outcome-driven definition of FCL systems.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>FCL systems are defined by three core domains centered on meeting intensive glycemic targets while reducing self-management burden and improving lived experience: Time in Tight Range (TITR) 70\u2013140 mg\/dL (3.9\u20137.8 mmol\/L), Time Below Range (TBR) &lt;54 mg\/dL (&lt;3.0 mmol\/L), and person-reported outcomes (PROs) measured with validated T1D-specific assessments. This definition rests on a three-tiered classification in which all FCL systems improve lived experience and attain &gt;50% TITR and &lt;1% TBR without mandatory meal or activity announcements. Class 3 systems must attain &gt;50% TITR; Class 2, &gt;70%; and Class 1, &gt;90%\u2014while simultaneously demonstrating improved quality of life and reduced treatment burden per validated PROs. Given the elevated hypoglycemia risk from insulin-on-board during exercise, Class 1a requires &gt;90% TITR with demonstrable hypoglycemia prevention during standardized exercise testing (0% TBR).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This framework provides a uniform benchmark for evaluating future FCL technologies. Taken together, this person-centered, outcome-driven framework holds that FCL systems should (1) autonomously attain near-normoglycemia, (2) meaningfully improve lived experience across the lifespan and clinical contexts, and (3) prevent exercise-related hypoglycemia.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/15209156261496643","type":"journal-article","created":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T21:00:11Z","timestamp":1791579611000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Roadmap to Fully Closing the Loop to Optimize Health in Type 1 Diabetes"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4849-9774","authenticated-orcid":false,"given":"Brynn E.","family":"Marks","sequence":"first","affiliation":[{"name":"Breakthrough T1D, New York, New York, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8813-629X","authenticated-orcid":false,"given":"Marisa E.","family":"Hilliard","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of Psychology, Baylor College of Medicine and Texas Children\u2019s Research Institute, Texas Children\u2019s Hospital, Houston, Texas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Boris","family":"Kovatchev","sequence":"additional","affiliation":[{"name":"Center for Diabetes Technology, School of Medicine, University of Virginia, Charlottesville, Virginia, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Othmar","family":"Moser","sequence":"additional","affiliation":[{"name":"Exercise Physiology, Training and Training Therapy Research Group, Department of Human Movement Sciences, Sport, and Health, Training and Diagnostic Centre, University of Graz, Graz, Austria."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Molly L.","family":"Tanenbaum","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Gerontology, and Metabolism, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA."},{"name":"Division of Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7110-5841","authenticated-orcid":false,"given":"Courtney","family":"Ackeifi","sequence":"additional","affiliation":[{"name":"Breakthrough T1D, New York, New York, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T.","family":"Ahn","sequence":"additional","affiliation":[{"name":"Mary and Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian, Newport Beach, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramzi A.","family":"Ajjan","sequence":"additional","affiliation":[{"name":"Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anastasia","family":"Albanese-O\u2019Neill","sequence":"additional","affiliation":[{"name":"Breakthrough T1D, New York, New York, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3881-0300","authenticated-orcid":false,"given":"Abdulmohsen","family":"Bakhsh","sequence":"additional","affiliation":[{"name":"Kidney &amp; 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