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| DCLP1 | Randomized Controlled Trial of Mobile Closed-Loop Control | This protocol, NCT02985866, is a 3-month parallel group, multicenter, randomized unblinded trial designed to comparemobile CLC with sensor augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ‡14 years, and baseline HbA1c <10.5% (91 mmol/mol). The study was designed to assess two coprimary outcomes: superiority of CLC over SAP in continuous glucose monitor (CGM)–measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L. | 2017-11-01 | 2018-05-01 | NCT02985866 | 127 | 32.29 | 47.24409448818898 | Boris Kovatchev,Bruce Buckingham,Carol Levy,Dan Raghinaru,David W. Lam,Elvira Isganaitis,Eyal Dassau,Francis J. Doyle III,Gregory P. Forlenza,John Lum,Jordan E. Pinsker,Laya Ekhlaspour,Lori M. Laffel,Mei Mei Church,R. Paul Wadwa,Roy W. Beck,Stacey M. Anderson,Sue A. Brown,Vikash Dadlani,Yogish C. Kudva |
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