PubMed | Northridge, University of Colorado at Denver, 4 Atlanta Diabetes Associates, Stanford University and 6 more.
Type: | Journal: Diabetes technology & therapeutics | Year: 2017
The safety and effectiveness of the in-home use of a hybrid closed-loop (HCL) system that automatically increases, decreases, and suspends insulin delivery in response to continuous glucose monitoring were investigated.Adolescents (n=30, ages 14-21 years) and adults (n=94, ages 22-75 years) with type 1 diabetes participated in a multicenter (nine sites in the United States, one site in Israel) pivotal trial. The Medtronic MiniMedAdolescents (meanstandard deviation [SD] 16.52.29 years of age and 7.74.15 years of diabetes) used the system for a median 75.8% (interquartile range [IQR] 68.0%-88.4%) of the time (2977 patient-days). Adults (meanSD 44.612.79 years of age and 26.412.43 years of diabetes) used the system for a median 88.0% (IQR 77.6%-92.7%) of the time (9412 patient-days). From baseline run-in to the end of study phase, adolescent and adult HbAHCL therapy was safe during in-home use by adolescents and adults and the study phase demonstrated increased time in target, and reductions in HbAClinicaltrials.gov identifier: NCT02463097.