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    Pilot Proof of Concept Clinical Trials of Stochastic Targeted (STAR) Glycemic Control (2011)

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    12635850_Annals Int Care - STAR Chch PRINTED.pdf (418.8Kb)
    Type of Content
    Journal Article
    UC Permalink
    http://hdl.handle.net/10092/6324
    
    Publisher's DOI/URI
    https://doi.org/10.1186/2110-5820-1-38
    
    Publisher
    University of Canterbury. Mechanical Engineering
    ISSN
    2110-5820
    Collections
    • Engineering: Journal Articles [1642]
    Authors
    Evans, A.
    Shaw, Geoff cc
    Le Compte, A.J.
    Tan, C.S.
    Ward, L.
    Steel, J.
    Pretty, C.G.
    Pfeifer, L.
    Penning, S.
    Suhaimi, F.
    Signal, M.
    Desaive, T.
    Chase, Geoff cc
    show all
    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.

    Citation
    Evans, A., Shaw, G.M., Le Compte, A.J., Tan, C.S., Ward, L., Steel, J., Pretty, C.G., Pfeifer, L., Penning, S., Suhaimi, F., Signal, M., Desaive, T., Chase, J.G. (2011) Pilot Proof of Concept Clinical Trials of Stochastic Targeted (STAR) Glycemic Control. Annals of Intensive Care, 1(38), pp. Online.
    This citation is automatically generated and may be unreliable. Use as a guide only.
    ANZSRC Fields of Research
    32 - Biomedical and clinical sciences::3202 - Clinical sciences::320212 - Intensive care
    32 - Biomedical and clinical sciences::3202 - Clinical sciences::320208 - Endocrinology
    32 - Biomedical and clinical sciences::3201 - Cardiovascular medicine and haematology::320102 - Haematology
    40 - Engineering::4003 - Biomedical engineering::400303 - Biomechanical engineering
    Rights
    https://hdl.handle.net/10092/17651

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    • Stochastic targeted (STAR) glycemic control: Design, safety and performance 

      Evans, A.; Le Compte, A.J.; Tan, C-S.; Ward, L.; Steel, J.; Pretty, C.G.; Penning, S.; Suhaimi, F.; Shaw, Geoff; Desaive, T.; Chase, Geoff (University of Canterbury. Mechanical Engineering, 2012)
      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 that directly ...
    • Safety and Performance of Stochastic Targeted (STAR) Glycemic Control of Insulin and Nutrition – First Pilot Results 

      Shaw, Geoff; Le Compte, A.J.; Evans, A.; Tan, C.S.; Steel, L.; Ward, L.; Pretty, C.G.; Penning, S.; Desaive, T.; Chase, Geoff (University of Canterbury. Mechanical Engineering, 2011)
    • Development and pilot trial results of stochastic targeted (STAR) glycemic control in a medical ICU 

      Fisk, L.; Le Compte, A.J.; Shaw, Geoff; Penning, S.; Desaive, T.; Chase, Geoff (University of Canterbury. Mechanical Engineering, 2012)
      Accurate glycemic control (AGC) is difficult due to excessive hypoglycemia risk. Stochastic TARgeted (STAR) glycemic control forecasts changes in insulin sensitivity to calculate a range of glycemic outcomes for an insulin ...
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