Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes
Author:
McVean Jennifer12, Forlenza Gregory P.3, Beck Roy W.4, Bauza Colleen4, Bailey Ryan4, Buckingham Bruce5, DiMeglio Linda A.6, Sherr Jennifer L.7, Clements Mark8, Neyman Anna6, Evans-Molina Carmella6, Sims Emily K.6, Messer Laurel H.39, Ekhlaspour Laya510, McDonough Ryan8, Van Name Michelle7, Rojas Diana4, Beasley Shannon1, DuBose Stephanie411, Kollman Craig4, Moran Antoinette1, Moran Antoinette12, McVean Jennifer12, Beasley Shannon12, Pappenfus Beth12, Street Anne12, Nelson Brittney12, Leschyshyn Janice12, Kennedy Jane12, Rizky Ihsan12, Forlenza Gregory12, Cobry Erin12, Messer Laurel12, Slover Robert12, Wadwa Paul12, Towers Lindsey12, Karami Angela12, Fivekiller Emily12, Boranian Emily12, Escobar Estella12, Jost Emily12, Lange Samantha12, Berget Cari12, Geiser Luke12, Clements Mark12, Moore Wayne12, McDonough Ryan12, Paprocki Emily12, Halpin Kelsee12, Yan Yun12, Livingston Erica12, Howell Kelsye12, Seuferling Barbara12, Parish Susan12, Orlich Stephen12, Goff Rachel12, Neyman Anna12, DiMeglio Linda12, Woerner Stephanie12, Evans-Molina Carmella12, Sims Emily12, Kirchner Megan12, Chatila Dana12, Buckingham Bruce12, Ekhlasour Laya12, Norlander Lisa12, Frank Eliana12, Suh Bailey12, Morgan Marci12, Kingman Ryan12, Hsu Liana12, Sherr Jennifer12, Weyman Kate12, Tichy Eileen12, Van Name Michelle12, Brei Michelle12, Steffen Amy12, Carria Lori12, Zgorski Melinda12, Bauza Colleen12, Beck Roy12, Bailey Ryan12, Kollman Craig12, DuBose Stephanie12, Rojas Diana12, Cagnina Nicole12, Reese Nicole12, Strayer Heidi12, Smith Emma12, Frey Sarah12, Vyas Shachi12, Rosen Jonathan12, Dutta Sanjoy12, Janicek Robert12, Gabrielson Deanna12, Yu Liping12, Stablein Donald12, Klingensmith Georgeanna12, Rodrigeuz Henry12,
Affiliation:
1. University of Minnesota, Minneapolis 2. now with Medtronic, Northridge, California 3. Barbara Davis Center, University of Colorado Anschutz Medical Campus, Denver 4. Jaeb Center for Health Research, Tampa, Florida 5. Stanford University, Stanford, California 6. Indiana University School of Medicine, Indianapolis 7. Yale School of Medicine, New Haven, Connecticut 8. Children’s Mercy Hospital, Kansas City, Missouri 9. now with Tandem Diabetes Care, San Diego, California 10. now with University of California, San Francisco 11. now with Emory University, Atlanta, Georgia 12. for the CLVer Study Group
Abstract
ImportanceNear 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.ObjectiveTo 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.Design, Setting, and ParticipantsThis 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.InterventionsRandom assignment to intensive diabetes management, which included use of an automated insulin delivery system (n = 61), or standard care, which included use of a continuous glucose monitor (n = 52), as part of a factorial design in which participants weighing 30 kg or more also were assigned to receive either oral verapamil or placebo.Main Outcomes and MeasuresThe primary outcome was mixed-meal tolerance test–stimulated C-peptide area under the curve (a measure of pancreatic beta cell function) 52 weeks from diagnosis.ResultsAmong 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, −0.01 [95% CI, −0.11 to 0.10]; P = .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.Conclusions and RelevanceIn 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.Trial RegistrationClinicalTrials.gov Identifier: NCT04233034
Publisher
American Medical Association (AMA)
Cited by
17 articles.
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