Alejandra Macias Pulido, MD; Linda Morrow, MD; Gabriela Campos-Cortes, MD; Julie Willard, MD; Moises Hernandez, MD; Marcus Hompesch, MD
Poster presented at the Diabetes Technology Meeting, North Bethesda, Maryland. 2019 Nov.
About this poster:
The euglycemic glucose clamp (GC) technique is the gold standard for the pharmacodynamic assessment of novel and biosimilar insulins. However, no currently accepted criteria exist to analyze clamp quality. This poster details the assessment of clamp quality parameters among different subject populations from a significant pool of data and evaluate acceptability criteria.
Methods summarized in the poster include the coefficient of variation (CV) and deviation from target (DFT) from 976 semi-automated (algorithm supported) euglycemic GCs using proprietary technology with the GlucoScout as the glucose sensor. These ≥24h clamps from 5 studies were performed to assess time-action profiles of long-acting insulins. CV is defined as the variability of blood glucose (BG) measurement: (Standard Deviation of BG/Mean BG)100. DFT is defined as the difference between BG and target level: [Mean (Measured BG – target level)/target level]100.