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Abstract
BACKGROUND This study assessed the efficacy and safety of ultra-rapid insulin Fiasp® in the hybrid closed-loop MiniMed™ 670G system. METHODS This was a pilot randomized, double-blinded, cross-over study among established MiniMed™ 670G users comparing percent time in range (TIR) and hypoglycemia for Novolog® and Fiasp®. Following two weeks optimization with their home insulin, participants were randomized to receive Novolog® or Fiasp® for two weeks, followed by the other insulin for the next two weeks. Data from the second week of blinded insulin use was analyzed to allow one week for 670G adaptation. During the second week, individuals were asked to eat the same breakfast for three days to assess differences in meal pharmacodynamics. RESULTS Nineteen adults were recruited with mean age of 40±18 years, diabetes duration of 27±12 years and median HbA1c of 7.1 (6.9,7.5)%, using 0.72 (0.4,1.2) units/kg/day. For Novolog® and Fiasp® respectively the %TIR (70-180mg/dL) was 75.3±9.5 and 78.4 ±9.3; %time <70mg/dL was 3.1±2.1 and 2.3±2.0; %time >180mg/dL was 21.6±9.0 and 19.3±8.9; mean glucose was 147±12 and 146±12mg/dL; coefficient of variation was 28.6±4.5% and 26.8±4.4%; %time in Auto Mode 86.4±9.2 and 84.4±9.2. All comparisons were non-significant for insulin type. Total daily dose (Novolog® 48.8±28.4 vs. Fiasp® 52.4±31.7 units; p=0.01) and daily basal (Novolog® 17.6 (15.5,33.8) vs. Fiasp® 19.1 (15.3,38.5) units; p=0.07) correlated with TIR and %time >180mg/dL. For insulin delivery in Auto Mode there was no statistical difference in total daily dose or daily basal between arms. Paired analysis for matched breakfast meals revealed no significant differences in time to maximum glucose, peak glucose or glucose excursion. CONCLUSIONS In this pilot study the use of either Novolog® or Fiasp® in a commercially available MiniMed™ 670G system operating in Auto Mode resulted in clinically similar glycemic outcomes, with a slight increase in daily insulin requirements using Fiasp®.
View details for DOI 10.1089/dia.2020.0083
View details for PubMedID 32520594