Virtual Trials of the NICE-SUGAR Protocol: The Impact on Performance of Protocol and Protocol Compliance

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dc.contributor.authorUyttendaele U
dc.contributor.authorDickson JL
dc.contributor.authorShaw, Geoff
dc.contributor.authorDesaive T
dc.contributor.authorChase, Geoff
dc.date.accessioned2018-01-11T23:12:40Z
dc.date.available2018-01-11T23:12:40Z
dc.date.issued2017en
dc.date.updated2017-08-07T04:35:55Z
dc.description.abstractHypoglycaemia, hyperglycaemia and blood glucose (BG) variability are associated with worsened outcomes in critical care. However, NICE-SUGAR trial showed no clinical benefit from intensive insulin therapy. This study compares the table-based NICE-SUGAR and model-based STAR protocols to assess their relative capability to achieve safe, effective control for all patients. Validated virtual patients (n=443) were used to simulate glycemic outcomes of the NICE-SUGAR and STAR protocols. Key outcomes evaluate tightness and safety of control for all patients: %BG in 80–144 mg/dL range (PTR); Per-Patient Mean BG (PPM_BG); and Incidence of Hypoglycaemia (BG<40 mg/dL). These metrics determine performance overall, for each patient, and safety. Results are assessed for NICE-SUGAR measuring per-protocol (~24/day) and at reported average rate (~3-hourly; ~8/day). STAR measures 1-3-hourly, averaging 12/day. Per-protocol, STAR provided tight control, with higher PTR (90.7% vs. 78.3%) and tighter median [IQR] PPM_BG (112[106-119] vs. 117[106–137] mg/dL), and greater safety from hypoglycaemia (5 (1%) vs. 10 patients (2.5%)) compared to NICE-SUGAR simulations as per protocol. The 5-95th percentile range PPM_BG for NICE-SUGAR (97–185 mg/dL) showed ~5% of NICE-SUGAR patients had mean BG above 180mg/dL matching clinically reported performance. STAR’s 5th-90th PPM_BG percentile range was (97–146 mg/dL). Measuring as recorded clinically, NICE-SUGAR had PTR of 77%, PPM_BG of 122 [110-140] mg/dL and 24(6%) of patients experienced hypoglycaemia. These results match clinically reported values well (mean BG 115 vs. 118 mg/dL clinically vs. simulation, clinically 7% of patients had a hypoglycemic event). Glycaemic control protocols need to be both safe and effective for all patients before potential clinical benefits can be assessed. NICE-SUGAR clinical results do not match results expected from their protocol, and show reduced safety and performance in comparison to STAR.en
dc.identifier.citationUyttendaele U, Dickson JL, Shaw GM, Desaive T, Chase JG (2017). Virtual Trials of the NICE-SUGAR Protocol: The Impact on Performance of Protocol and Protocol Compliance. Toulouse, France: IFAC (International Fedaration of Automated Control) 20th World Congress. 09/07/2017-14/07/2017.en
dc.identifier.doihttps://doi.org/10.1016/j.ifacol.2017.08.1159
dc.identifier.urihttp://hdl.handle.net/10092/14944
dc.language.isoen
dc.rightsCreative Commons Attribution Non-Commercial No Derivatives Licenseen
dc.subjectglucoseen
dc.subjecthyperglycaemiaen
dc.subjectglycaemic controlen
dc.subjectinsulin sensitivityen
dc.subject.anzsrcFields of Research::40 - Engineering::4003 - Biomedical engineering::400303 - Biomechanical engineeringen
dc.subject.anzsrcFields of Research::32 - Biomedical and clinical sciences::3202 - Clinical sciences::320208 - Endocrinologyen
dc.titleVirtual Trials of the NICE-SUGAR Protocol: The Impact on Performance of Protocol and Protocol Complianceen
dc.typeConference Contributions - Publisheden
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