Interface Design and Human Factors Consideration for Model-Based Tight Glycemic Control in Critical Care; ; et al in Journal of Diabetes Science and Technology (2012) Detailed reference viewed: 10 (2 ULg) Stochastic Targeted (STAR) Glycemic Control - Design, Safety and Performance; ; et al in Journal of Diabetes Science and Technology (2012) Detailed reference viewed: 13 (3 ULg) Data Entry Errors and Design for Model-Based Tight Glycemic Control in Critical Care; ; et al in Journal of Diabetes Science and Technology (2012) Detailed reference viewed: 10 (8 ULg) Enhanced insulin sensitivity variability in the first 3 days of ICU stay: Implications for TGC; ; Penning, Sophie et alin Critical Care (2011, March) Detailed reference viewed: 11 (7 ULg) Validation of a virtual patient and virtual trials method for accurate prediction of TGC protocol performance; ; Penning, Sophie et alin Critical Care (2011, March) Detailed reference viewed: 16 (8 ULg) Validation of a Virtual Patient and Virtual Trials Method for Accurate Prediction of TGC Protocol Performance; ; Penning, Sophie et alPoster (2011, March) Detailed reference viewed: 18 (7 ULg) Enhanced insulin sensitivity variability in the first 3 days of ICU stay: Implications for TGC; ; Penning, Sophie et alPoster (2011, March) Detailed reference viewed: 19 (7 ULg) Safety and Performance of Stochastic Targeted (STAR) TGC of Insulin and Nutrition; ; et al in Proceedings of SQAO 2011 (2011) Detailed reference viewed: 12 (0 ULg) Pilot Trials of STAR Target to Range Glycemic ControlPenning, Sophie ; ; et alin Intensive Care Medicine (2011), 37 (Suppl 1) Detailed reference viewed: 13 (5 ULg) Variability of insulin sensitivity for diabetics and non-diabetics during the first 3 days of ICU stay; ; et al in Intensive Care Medicine (2011), 37 (Suppl 1) Detailed reference viewed: 9 (3 ULg)![]() Variability of insulin sensitivity for diabetics and non-diabetics during the first 3 days of ICU stay; ; et al Poster (2011) Detailed reference viewed: 7 (2 ULg)![]() Safety and Performance of Stochastic Targeted (STAR) Glycemic Control of Insulin and Nutrition - First Pilot Results; ; et al Poster (2011) Detailed reference viewed: 6 (2 ULg) Safety and Performance of Stochastic Targeted (STAR) Glycemic Control of Insulin and Nutrition – First Pilot Results; ; et al in Intensive Care Medicine (2011) Detailed reference viewed: 9 (2 ULg) Pilot Trials of STAR Target to Range Glycemic ControlPenning, Sophie ; ; et alPoster (2011) Detailed reference viewed: 8 (2 ULg) Pilot proof of concept clinical trials of Stochastic Targeted (STAR) glycemic control.; ; et al in Annals of intensive care (2011), 1 ABSTRACT: INTRODUCTION: Tight glycemic control (TGC) has shown benefits but has been difficult to achieve consistently. STAR (Stochastic TARgeted) is a flexible, model-based TGC approach directly ... [more ▼] ABSTRACT: INTRODUCTION: Tight glycemic control (TGC) has shown benefits but has been difficult to achieve consistently. STAR (Stochastic TARgeted) is a flexible, model-based TGC approach directly accounting for intra- and inter- patient variability with a stochastically derived maximum 5% risk of blood glucose (BG) < 4.0 mmol/L. This research assesses the safety, efficacy, and clinical burden of a STAR TGC controller modulating both insulin and nutrition inputs in pilot trials. METHODS: Seven patients covering 660 hours. Insulin and nutrition interventions are given 1-3 hourly as chosen by the nurse to allow them to manage workload. Interventions are calculated by using clinically validated computer models of human metabolism and its variability in critical illness to maximize the overlap of the model-predicted (5-95th percentile) range of BG outcomes with the 4.0-6.5 mmol/L band while ensuring a maximum 5% risk of BG < 4.0 mmol/L. Carbohydrate intake (all sources) was selected to maximize intake up to 100% of SCCM/ACCP goal (25 kg/kcal/h). Maximum insulin doses and dose changes were limited for safety. Measurements were made with glucometers. Results are compared to those for the SPRINT study, which reduced mortality 25-40% for length of stay >/=3 days. Written informed consent was obtained for all patients, and approval was granted by the NZ Upper South A Regional Ethics Committee. RESULTS: A total of 402 measurements were taken over 660 hours (~14/day), because nurses showed a preference for 2-hourly measurements. Median [interquartile range, (IQR)] cohort BG was 5.9 mmol/L [5.2-6.8]. Overall, 63.2%, 75.9%, and 89.8% of measurements were in the 4.0-6.5, 4.0-7.0, and 4.0-8.0 mmol/L bands. There were no hypoglycemic events (BG < 2.2 mmol/L), and the minimum BG was 3.5 mmol/L with 4.5% < 4.4 mmol/L. Per patient, the median [IQR] hours of TGC was 92 h [29-113] using 53 [19-62] measurements (median, ~13/day). Median [IQR] results: BG, 5.9 mmol/L [5.8-6.3]; carbohydrate nutrition, 6.8 g/h [5.5-8.7] (~70% goal feed median); insulin, 2.5 U/h [0.1-5.1]. All patients achieved BG < 6.1 mmol/L. These results match or exceed SPRINT and clinical workload is reduced more than 20%. CONCLUSIONS: STAR TGC modulating insulin and nutrition inputs provided very tight control with minimal variability by managing intra- and inter- patient variability. Performance and safety exceed that of SPRINT, which reduced mortality and cost in the Christchurch ICU. The use of glucometers did not appear to impact the quality of TGC. Finally, clinical workload was self-managed and reduced 20% compared with SPRINT. [less ▲] Detailed reference viewed: 13 (10 ULg) Tight Glycemic Control Models for Critically Ill Patients in Intensive Care UnitsPenning, Sophie ; ; Desaive, Thomas et alPoster (2010, November 26) Detailed reference viewed: 14 (8 ULg) Tight Glycemic Control Models for Critically Ill Patients in Intensive Care UnitsPenning, Sophie ; ; Moorhead, Katherine et alin 9th Belgian Day on Biomedical Engineering, "Bridging the gap between medicine and engineering', Friday November 26th 2010 in the Academy Palace, Hertogstraat 1, 1000 Brussels (2010, November 26) Critically ill patients often present stress-induced hyperglycemia and low insulin sensitivity. Recent studies have shown that high blood glucose (BG) levels are linked to worsened patient outcomes and ... [more ▼] Critically ill patients often present stress-induced hyperglycemia and low insulin sensitivity. Recent studies have shown that high blood glucose (BG) levels are linked to worsened patient outcomes and increased mortality. Tight glycemic control (TGC) aims at reducing BG levels taking into account inter-patient variability, evolving physiological patient conditions and minimizing hypoglycemic risks. Clinical protocols are used to specify insulin and nutrition rates and BG measurement time interval during control. This research compares different protocols to determine the best one to use at the CHU of Liege. [less ▲] Detailed reference viewed: 22 (6 ULg) What makes tight glycemic control tight? The impact of variability and nutrition in two clinical studies.; ; Preiser, Jean-Charles et alin Journal of Diabetes Science and Technology (2010), 4(2), 284-98 INTRODUCTION: Tight glycemic control (TGC) remains controversial while successful, consistent, and effective protocols remain elusive. This research analyzes data from two TGC trials for root causes of ... [more ▼] INTRODUCTION: Tight glycemic control (TGC) remains controversial while successful, consistent, and effective protocols remain elusive. This research analyzes data from two TGC trials for root causes of the differences achieved in control and thus potentially in glycemic and other outcomes. The goal is to uncover aspects of successful TGC and delineate the impact of differences in cohorts. METHODS: A retrospective analysis was conducted using records from a 211-patient subset of the GluControl trial taken in Liege, Belgium, and 393 patients from Specialized Relative Insulin Nutrition Titration (SPRINT) in New Zealand. Specialized Relative Insulin Nutrition Titration targeted 4.0-6.0 mmol/liter, similar to the GluControl A (N = 142) target of 4.4-6.1 mmol/liter. The GluControl B (N = 69) target was 7.8-10.0 mmol/liter. Cohorts were matched by Acute Physiology and Chronic Health Evaluation II score and percentage males (p > .35); however, the GluControl cohort was slightly older (p = .011). Overall cohort and per-patient comparisons (median, interquartile range) are shown for (a) glycemic levels achieved, (b) nutrition from carbohydrate (all sources), and (c) insulin dosing for this analysis. Intra- and interpatient variability were examined using clinically validated model-based insulin sensitivity metric and its hour-to-hour variation. RESULTS: Cohort blood glucose were as follows: SPRINT, 5.7 (5.0-6.6) mmol/liter; GluControl A, 6.3 (5.3-7.6) mmol/liter; and GluControl B, 8.2 (6.9-9.4) mmol/liter. Insulin dosing was 3.0 (1.0-3.0), 1.5 (0.5-3), and 0.7 (0.0-1.7) U/h, respectively. Nutrition from carbohydrate (all sources) was 435.5 (259.2-539.1), 311.0 (0.0-933.1), and 622.1 (103.7-1036.8) kcal/day, respectively. Median per-patient results for blood glucose were 5.8 (5.3-6.4), 6.4 (5.9-6.9), and 8.3 (7.6-8.8) mmol/liter. Insulin doses were 3.0 (2.0-3.0), 1.5 (0.8-2.0), and 0.5 (0.0-1.0) U/h. Carbohydrate administration was 383.6 (207.4-497.7), 103.7 (0.0-829.4), and 207.4 (0.0-725.8) kcal/day. Overall, SPRINT gave approximately 2x more insulin with a 3-4x narrower, but generally non-zero, range of nutritional input to achieve equally TGC with less hypoglycemia. Specialized Relative Insulin Nutrition Titration had much less hypoglycemia (<2.2 mmol/liter), with 2% of patients, compared to GluControl A (7.7%) and GluControl B (2.9%), indicating much lower variability, with similar results for glucose levels <3.0 mmol/liter. Specialized Relative Insulin Nutrition Titration also had less hyperglycemia (>8.0 mmol/liter) than groups A and B. GluControl patients (A+B) had a approximately 2x wider range of insulin sensitivity than SPRINT. Hour-to-hour variation was similar. Hence GluControl had greater interpatient variability but similar intrapatient variability. CONCLUSION: Protocols that dose insulin blind to carbohydrate administration can suffer greater outcome glycemic variability, even if average cohort glycemic targets are met. While the cohorts varied significantly in model-assessed insulin resistance, their variability was similar. Such significant intra- and interpatient variability is a further significant cause and marker of glycemic variability in TGC. The results strongly recommended that TGC protocols be explicitly designed to account for significant intra- and interpatient variability in insulin resistance, as well as specifying or having knowledge of carbohydrate administration to minimize variability in glycemic outcomes across diverse cohorts and/or centers. [less ▲] Detailed reference viewed: 32 (5 ULg) |
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