drh_study (view) Content
| DCLP1 | Randomized Controlled Trial of Mobile Closed-Loop Control | 2017-11-01 | 2018-05-01 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant UC4-DK-108483. | NCT02985866 | 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. |
(Page 1 of 1)