{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T07:27:32Z","timestamp":1793345252591,"version":"4.5.0"},"reference-count":14,"publisher":"American Medical Association (AMA)","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2023,3,28]]},"abstract":"<jats:sec><jats:title>Importance<\/jats:title><jats:p>Near normalization of glucose levels instituted immediately after diagnosis of type 1 diabetes has been postulated to preserve pancreatic beta cell function by reducing glucotoxicity. Previous studies have been hampered by an inability to achieve tight glycemic goals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine the effectiveness of intensive diabetes management to achieve near normalization of glucose levels on preservation of pancreatic beta cell function in youth with newly diagnosed type 1 diabetes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>This randomized, double-blind, clinical trial was conducted at 6 centers in the US (randomizations from July 20, 2020, to October 13, 2021; follow-up completed September 15, 2022) and included youths with newly diagnosed type 1 diabetes aged 7 to 17 years.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Random assignment to intensive diabetes management, which included use of an automated insulin delivery system (n\u2009=\u200961), or standard care, which included use of a continuous glucose monitor (n\u2009=\u200952), as part of a factorial design in which participants weighing 30 kg or more also were assigned to receive either oral verapamil or placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>The primary outcome was mixed-meal tolerance test\u2013stimulated C-peptide area under the curve (a measure of pancreatic beta cell function) 52 weeks from diagnosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 113 participants (mean [SD] age, 11.8 [2.8] years; 49 females [43%]; mean [SD] time from diagnosis to randomization, 24 [5] days), 108 (96%) completed the trial. The mean C-peptide area under the curve decreased from 0.57 pmol\/mL at baseline to 0.45 pmol\/mL at 52 weeks in the intensive management group, and from 0.60 to 0.50 pmol\/mL in the standard care group (treatment group difference, \u22120.01 [95% CI, \u22120.11 to 0.10]; <jats:italic>P<\/jats:italic>\u2009=\u2009.89). The mean time in the target range of 70 to 180 mg\/dL, measured with continuous glucose monitoring, at 52 weeks was 78% in the intensive management group vs 64% in the standard care group (adjusted difference, 16% [95% CI, 10% to 22%]). One severe hypoglycemia event and 1 diabetic ketoacidosis event occurred in each group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and Relevance<\/jats:title><jats:p>In youths with newly diagnosed type 1 diabetes, intensive diabetes management, which included automated insulin delivery, achieved excellent glucose control but did not affect the decline in pancreatic C-peptide secretion at 52 weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04233034\">NCT04233034<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jama.2023.2063","type":"journal-article","created":{"date-parts":[[2023,2,24]],"date-time":"2023-02-24T16:00:27Z","timestamp":1677254427000},"page":"980","source":"Crossref","is-referenced-by-count":88,"title":["Effect of Tight Glycemic Control on 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