Fast-acting insulin aspart (Fiasp®) improves glycemic outcomes when used with MiniMed™ 670G hybrid closed-loop system in simulated trials compared to NovoLog®

Introduction: Medtronic has developed a virtual patient simulator for modeling and predicting insulin therapy outcomes for people with type 1 diabetes (T1D). An enhanced simulator was created to estimate outcomes when using the MiniMed (TM) 670G system with standard NovoLog (R) (EU: NovoRapid, US: NovoLog) versus Fiasp (R) by using clinical data. Methods: Sixty-seven participants' PK profiles were generated per type of insulin (Total of 134 PK profiles). 7,485 virtual patients' PK measurements was matched with one of the 67 NovoLog (R) PK Tmax values. These 7,485 virtual patients were then simulated using the Medtronic MiniMed (TM) 670G algorithm following an in-silico protocol of 90 days: 14 days in open loop (Manual Mode) followed by 76 days in closed loop (Auto Mode). Simulation study was repeated with each NovoLog (R) PK profile being replaced by its corresponding Fiasp (R) PK profile in the same virtual patient. To validate our in-silico analysis, we compared the results of "actual" 19 "real life" patients from a clinical study Results: Simulated overall and postprandial glycemic outcomes improved in all age groups with Fiasp (R). The percentage of time in the euglycemic range increased by about similar to 2.2% with Fiasp (R), in all age groups (p < 0.01). The percentage of time spent at <70 mg/dL was reduced by about similar to 0.6% with insulin Fiasp (R) (p < 0.01) and the mean glucose was reduced by about 1.3 mg/dL (p < 0.01), excluding those age <7 years. The simulated mean postprandial SG was reduced by similar to 5 mg/dL, a significant difference for all age groups. A clinical study results showed similar improvements with MiniMed (TM) 670G system when switching from NovoLog (R) to Fiasp (R). Conclusions: The simulation studies indicate that using Fiasp (R) in place of NovoLog (R) with the MiniMed (TM) 670G system will significantly improve the time spent in the healthy, euglycemic range and reduce exposure to hyperglycemia and hypoglycemia in most patients. (C) 2021 Elsevier B.V. Allrights reserved.