Real-World Data from the MiniMed™ 670G System Commercial Launch—The First 1,052 Patients Using the System for Three Months

Abstract

The Medtronic MiniMed™ 670G hybrid closed-loop system with SmartGuard™ technology was released for commercial use in the U.S. in March 2017. Sensor glucose (SG) and device utilization data from the initial open-loop Manual Mode and closed-loop Auto Mode periods were analyzed for the first 1052 patients and compared to those from the MiniMed™ 670G system pivotal trial1. De-identified data voluntarily uploaded to CareLink™ Personal software, from 3/17/17 to 11/11/17, were evaluated monthly, for 3 months. Data for 12,758 patient-days in Manual Mode and 142,065 patient-days after Auto Mode start were compared to results of the MiniMed™ 670G pivotal trial (124 patients aged 14-75 years) conducted from 6/2/15 to 3/7/16. The percentage of time in Auto Mode, after initiation, was >85% over the 3 months for the entire commercial cohort. The SG values across glucose ranges were comparable to pivotal trial data (Table). These findings indicate that outcomes data for the first 1052 patients using the commercial MiniMed™ 670G system mirrored the pivotal trial outcomes. Further, the increased time in target range and decreased hypoglycemia and hyperglycemia were sustained over 3 months. Pivotal TrialCommercial LaunchManual ModeAuto ModeManual ModeAuto Mode Month 1Auto Mode Month 2Auto Mode Month 3Patients, N1241241052105210521052Auto Mode Use, %-87.20-88.6086.7885.96Mean SG, mg/dL150.2150.78157.02149.84150.30150.75Percentage of time in SG range, mg/dL<500.850.520.380.300.320.33<541.330.780.600.460.500.52<705.472.952.652.072.212.2370-18067.1372.6167.3975.0074.3674.07>18027.424.4529.9622.9323.4323.70>2506.945.587.494.504.865.14 1. Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes. Diabetes Technol Ther. 2017;19:155-163. Disclosure P. Agrawal: None. M. Stone: None. S. Gopalakrishnan: Employee; Self; Medtronic. C. Fogel: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.