97-LB: Safety and Glycemic Outcomes of the MiniMed Advanced Hybrid Closed-Loop (AHCL) System in Subjects with T1D

• Published in: Diabetes (New York, N.Y.) Vol. 69; no. Supplement_1
• Main Authors: CARLSON, ANDERS L., BODE, BRUCE W., BRAZG, RONALD L., CHRISTIANSEN, MARK P., GARG, SATISH K., KAISERMAN, KEVIN, KIPNES, MARK, LILJENQUIST, DAVID R., PHILIS-TSIMIKAS, ATHENA, POP-BUSUI, RODICA, SHERR, JENNIFER, SHULMAN, DOROTHY I., SINGH, KAMALPREET K., SLOVER, ROBERT H., THRASHER, JAMES, CHEN, XIAOXIAO, GROSMAN, BENYAMIN, LEE, SCOTT W., LINTEREUR, LOUIS J., LIU, MARGARET, PARIKH, NEHA, RHINEHART, ANDREW S., PENG, FEN, ROY, ANIRBAN, SHIN, JOHN, WU, DI, VIGERSKY, ROBERT
• Format: Journal Article
• Language: English
• Published: New York American Diabetes Association 01.06.2020
• Subjects: Closed loop systems; Diabetes; Glucose monitoring; Hypoglycemia; Insulin
• ISSN: 0012-1797; 1939-327X
• DOI: 10.2337/db20-97-LB

Background: Automated insulin delivery systems improve glycemic control including time spent in, below and above range (TIR, TBR and TAR, respectively) in people with T1D. A next generation system, the MiniMedTM AHCL system, that offers a target set point (SP) of 100 or 120mg/dL, autocorrects to 120mg/dL every 5 mins and has fewer Auto Mode exits, was evaluated. Methods: A 16-site, single-arm, in-home trial of the AHCL system in 39 adolescents (14-21yrs) and 118 adults (≥22yrs) with T1D was conducted. After a baseline period of sensor-integrated pump, HCL feature, or predictive low glucose feature use (~14 days), the AHCL feature was enabled with a 100 or 120mg/dL SP for ~45 days and then the other SP for ~45 days. Study endpoints included safety events, change in A1C, sensor glucose (SG), %TIR, %TBR and %TAR. Results: There were no DKA or severe hypoglycemia episodes during the study period. Auto Mode was used ≥95% of the time; autocorrection was 22% of daily bolus. The table shows outcomes (mean±SD) for the overall group and each age group at baseline and study period (100 and 120mg/dL SP), and at the 100mg/dL SP. Best glycemic results (SG of 141±8.8mg/dL, TIR of 78.8±5.5% and TBR of 2.6±2.0%; N=29) were seen with a 100mg/dL SP and active insulin time of 120 minutes. Conclusion: These pivotal trial data demonstrate that AHCL is safe and significantly improved A1C and SG in subjects aged ≥14 years with T1D.