Insulin Glargine in the Intensive Care Unit: A Model-Based Clinical Trial Design (2013)
Type of ContentJournal Article
PublisherUniversity of Canterbury. Mechanical Engineering
AuthorsWillis, J.G., Fisk, L., Razak, N., Le Compte, A.J., Shaw, G.M., Chase, J.G.show all
Introduction: Current succesful AGC (Accurate Glycemic Control) protocols require extra clinical effort and are impractical in less acute wards where patients are still susceptible to stress-induced hyperglycemia. Long-acting insulin Glargine has the potential to be used in a low effort controller. However, potential variability in efficacy and length of action, prevent direct in-hospital use in an AGC framework for less acute wards. Method: Clinically validated virtual trials based on data from stable ICU patients from the SPRINT cohort who would be transferred to such an approach are used to develop a 24-hour AGC protocol robust to different Glargine potencies (1.0x, 1.5x and 2.0x regular insulin) and initial dose sizes (dose = total insulin over prior 12, 18 and 24 hours). Glycemic control in this period is provided only by varying nutritional inputs. Performance is assessed as %BG in the 4.0-8.0mmol/L band and safety by %BG<4.0mmol/L. Results: The final protocol consisted of Glargine bolus size equal to insulin over the previous 18 hours. Compared to SPRINT there was a 6.9% - 9.5% absolute decrease in mild hypoglycemia (%BG<4.0mmol/L) and up to a 6.2% increase in %BG between 4.0 and 8.0mmol/L. When the efficacy is known (1.5x assumed) there were reductions of: 27% BG measurements, 59% insulin boluses, 67% nutrition changes, and 6.3% absolute in mild hypoglycemia. Conclusion: A robust 24-48 clinical trial has been designed to safely investigate the efficacy and kinetics of Glargine as a first step towards developing a Glargine-based protocol for less acute wards. Ensuring robustness to variability in Glargine efficacy significantly affects the performance and safety that can be obtained.
CitationWillis, J.G., Fisk, L., Razak, N., Le Compte, A.J., Shaw, G.M., Chase, J.G. (2013) Insulin Glargine in the Intensive Care Unit: A Model-Based Clinical Trial Design. Biomedical Signal Processing & Control (BSPC), 8(2), pp. 120-129.
This citation is automatically generated and may be unreliable. Use as a guide only.
Keywordsclinical trial; simulation; glycemic control
ANZSRC Fields of Research11 - Medical and Health Sciences::1103 - Clinical Sciences::110306 - Endocrinology
11 - Medical and Health Sciences::1103 - Clinical Sciences::110310 - Intensive Care