The Medtronic MiniMed™ 670G hybrid closed-loop (HCL) system was investigated in a multi-center pivotal trial conducted in 1T1D children aged 7-13 years. A 3-month at-home study phase with Auto Mode enabled followed the 2 week run-in phase in Manual Mode. The system improved overall glycemic control and minimized the percentage of time in hypoglycemia (≤70mg/dL, 3.9mmol/L). Several aspects of the postprandial response and sensor glucose (SG) values, during the run-in and study were compared. The maximum increase in SG (mg/dL) per 50 grams of carbohydrate (carb) in postprandial responses >3h; settling time, defined as the minutes for the postprandial response to settle back to <10mg/dL of the glycemic value at meal start; and the 3-h postprandial distribution of SG values were analyzed. Analyses were separated into 4-11am, 11am-4pm, and 4pm-4am periods. The median (IQR) for the postprandial maximum SG increase 4-11am was 91 (139) and 96 (136) mg/dL, p=0.34; for 11am-4pm was 86 (152) and 82 (141) mg/dL, p=0.66; and for 4pm-4am was 102(182) and 87.5 (166), p<0.001, for run-in and study, respectively. That for settling time for 4-11am was 192 (176) and 189 (158) min, p<0.001; for 11am-4am was 195.5 (213) and 191 (217) min, p=0.24; and for 4pm-4am was 295 (555) and 221 (447) min, p<0.001, respectively. That for 3-h postprandial SG values for 4-11am was 154 (106) and 150.5 (88) mg/dL, p=0.004; for 11am-4pm was 159.5 (104) and 153 (93) mg/dL, p<0.001; and for 4pm-4am was 163 (106) and 158 (89) mg/dL, p=0.001, respectively. The postprandial response in most of the tested outcomes between the study and run-in phase was significantly improved when the MiniMed™ 670G Auto Mode feature was enabled. For meals consumed between 4pm-4am, a reduction of 14.5 mg/dL was observed in the median maximum SG per 50 grams of carb. Furthermore, for meals consumed between 4pm-4am, settling time was reduced by 74 minutes. Overall, the HCL system reduced postprandial excursions and settling times throughout the day, while showing significant improvements 4pm-4am.


B. Grosman: Employee; Self; Medtronic. A. Roy: Employee; Self; Medtronic MiniMed, Inc.. D. Wu: None. N. Parikh: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.

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