{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T16:53:03Z","timestamp":1793292783128,"version":"4.5.0"},"reference-count":43,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2022,3,1]],"date-time":"2022-03-01T00:00:00Z","timestamp":1646092800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2022,3,1]],"date-time":"2022-03-01T00:00:00Z","timestamp":1646092800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Technology &amp; Therapeutics"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction:<\/jats:title>\n                    <jats:p>This trial assessed safety and effectiveness of an advanced hybrid closed-loop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods:<\/jats:title>\n                    <jats:p>\n                      This multicenter single-arm study involved an intent-to-treat population of 157 individuals (39 adolescents aged 14\u201321 years and 118 adults aged \u226522\u201375 years) with T1D. Study participants used the MiniMed\u2122 AHCL system during a baseline run-in period in which sensor-augmented pump +\/\u2212 predictive low glucose management or Auto Basal was enabled for \u223c14 days. Thereafter, Auto Basal and Auto Correction were enabled for a study phase (\u223c90 days), with glucose target set to 100 or 120\u2009mg\/dL for \u223c45 days, followed by the other target for \u223c45 days. Study endpoints included safety events and change in mean A1C, time in range (TIR, 70\u2013180\u2009mg\/dL) and time below range (TBR, &lt;70\u2009mg\/dL). Run-in and study phase values were compared using Wilcoxon signed-rank test or paired\n                      <jats:italic toggle=\"yes\">t<\/jats:italic>\n                      -test.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Overall group time spent in closed loop averaged 94.9%\u2009\u00b1\u20095.4% and involved only 1.2\u2009\u00b1\u20090.8 exits per week. Compared with run-in, AHCL reduced A1C from 7.5%\u2009\u00b1\u20090.8% to 7.0%\u2009\u00b1\u20090.5% (&lt;0.001, Wilcoxon signed-rank test,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009155), TIR increased from 68.8%\u2009\u00b1\u200910.5% to 74.5%\u2009\u00b1\u20096.9% (&lt;0.001, Wilcoxon signed-rank test), and TBR reduced from 3.3%\u2009\u00b1\u20092.9% to 2.3%\u2009\u00b1\u20091.7% (&lt;0.001, Wilcoxon signed-rank test). Similar benefits to glycemia were observed for each age group and were more pronounced for the nighttime (12 AM\u20136 AM). The 100\u2009mg\/dL target increased TIR to 75.4% (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009155), which was further optimized at a lower active insulin time (AIT) setting (i.e., 2\u2009h), without increasing TBR. There were no severe hypoglycemic or diabetic ketoacidosis events during the study phase.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>These findings show that the MiniMed AHCL system is safe and allows for achievement of recommended glycemic targets in adolescents and adults with T1D. Adjustments in target and AIT settings may further optimize glycemia and improve user experience.<\/jats:p>\n                    <jats:p>Clinical Trial Registration number: NCT03959423.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/dia.2021.0319","type":"journal-article","created":{"date-parts":[[2021,10,25]],"date-time":"2021-10-25T12:39:00Z","timestamp":1635165540000},"page":"178-189","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":222,"title":["Safety and Glycemic Outcomes During the MiniMed\u2122 Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes"],"prefix":"10.1177","volume":"24","author":[{"given":"Anders L.","family":"Carlson","sequence":"first","affiliation":[{"name":"International Diabetes Center, HealthPartners Institute, Minneapolis, Minnesota, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer L.","family":"Sherr","sequence":"additional","affiliation":[{"name":"Yale University School of Medicine Pediatric Endocrinology, New Haven, Connecticut, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dorothy I.","family":"Shulman","sequence":"additional","affiliation":[{"name":"University of South Florida Diabetes and Endocrinology, Tampa, Florida, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satish K.","family":"Garg","sequence":"additional","affiliation":[{"name":"Barbara Davis Center of Childhood Diabetes, Aurora, Colorado, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodica","family":"Pop-Busui","sequence":"additional","affiliation":[{"name":"Division of Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor, Michigan, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce W.","family":"Bode","sequence":"additional","affiliation":[{"name":"Atlanta Diabetes Associates, Atlanta, Georgia, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Lilenquist","sequence":"additional","affiliation":[{"name":"Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ron L.","family":"Brazg","sequence":"additional","affiliation":[{"name":"Rainier Clinical Research Center, Renton, Washington, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin B.","family":"Kaiserman","sequence":"additional","affiliation":[{"name":"SoCal Diabetes, Torrance, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark S.","family":"Kipnes","sequence":"additional","affiliation":[{"name":"Diabetes and Glandular Disease Clinic, San Antonio, Texas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James R.","family":"Thrasher","sequence":"additional","affiliation":[{"name":"Arkansas Diabetes and Endocrinology Center, Little Rock, Arkansas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John H. Chip","family":"Reed","sequence":"additional","affiliation":[{"name":"Endocrine Research Solutions, Inc., Roswell, Georgia, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert H.","family":"Slover","sequence":"additional","affiliation":[{"name":"Barbara Davis Center of Childhood Diabetes, Aurora, Colorado, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Athena","family":"Philis-Tsimikas","sequence":"additional","affiliation":[{"name":"Scripps Whittier Diabetes Institute, La Jolla, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Christiansen","sequence":"additional","affiliation":[{"name":"Diablo Clinical Research Center, Walnut Creek, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benyamin","family":"Grosman","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anirban","family":"Roy","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Vella","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard A.M.","family":"Jonkers","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoxiao","family":"Chen","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Shin","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4597-4194","authenticated-orcid":false,"given":"Toni L.","family":"Cordero","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott W.","family":"Lee","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew S.","family":"Rhinehart","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3546-3385","authenticated-orcid":false,"given":"Robert A.","family":"Vigersky","sequence":"additional","affiliation":[{"name":"Medtronic, Northridge, California, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the MiniMed\u2122 AHCL Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,3,14]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.2337\/dc15-2078"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2016.0333"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2015.0431"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2019.0011"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/pedi.12071"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2016.11708"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2019.0286"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1907863"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1089\/dia.2019.0400"},{"key":"e_1_3_4_11_2","first-page":"794","article-title":"Reduced burden of diabetes and improved quality of life: experiences from unrestricted day-and-night hybrid closed-loop use in very young children with type 1 diabetes","volume":"20","author":"Musolino G","year":"2019","unstructured":"Musolino G, , Dovc K, , Boughton CK, et al.: Reduced burden of diabetes and improved quality of life: experiences from unrestricted day-and-night hybrid closed-loop use in very young children with type 1 diabetes. 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