BACKGROUND STAR is a model-based, personalised, risk-based dosing approach for glycaemic control (GC) in critically ill patients. STAR provides safe, effective control to nearly all patients, using 1-3 hourly measurement and intervention intervals. However, the average 11-12 measurements per day required can be a clinical burden in many intensive care units. This study aims to significantly reduce workload by extending STAR 1-3 hourly intervals to 1 to 4-, 5-, and 6-hourly intervals, and evaluate the impact of these longer intervals on GC safety and efficacy, using validated in silico virtual patients and trials methods. A Standard STAR approach was used which allowed more hyperglycaemia over extended intervals, and a STAR Upper Limit Controlled approach limited nutrition to mitigate hyperglycaemia over longer intervention intervals. RESULTS Extending STAR from 1-3 hourly to 1-6 hourly provided high safety and efficacy for nearly all patients in both approaches. For STAR Standard, virtual trial results showed lower % blood glucose (BG) in the safe 4.4-8.0 mmol/L target band (from 83 to 80%) as treatment intervals increased. Longer intervals resulted in increased risks of hyper- (15% to 18% BG > 8.0 mmol/L) and hypo- (2.1% to 2.8% of patients with min. BG < 2.2 mmol/L) glycaemia. These results were achieved with slightly reduced insulin (3.2 [2.0 5.0] to 2.5 [1.5 3.0] U/h) and nutrition (100 [85 100] to 90 [75 100] % goal feed) rates, but most importantly, with significantly reduced workload (12 to 8 measurements per day). The STAR Upper Limit Controlled approach mitigated hyperglycaemia and had lower insulin and significantly lower nutrition administration rates. CONCLUSIONS The modest increased risk of hyper- and hypo-glycaemia, and the reduction in nutrition delivery associated with longer treatment intervals represent a significant risk and reward trade-off in GC. However, STAR still provided highly safe, effective control for nearly all patients regardless of treatment intervals and approach, showing this unique risk-based dosing approach, modulating both insulin and nutrition, to be robust in its design. Clinical pilot trials using STAR with different measurement timeframes should be undertaken to confirm these results clinically.

中文翻译：

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风险和回报：延长随机血糖控制时间间隔以减少工作量。

背景技术STAR是重症患者血糖控制（GC）的基于模型，个性化，基于风险的给药方法。STAR使用1-3小时的测量和干预间隔，为几乎所有患者提供安全，有效的控制。但是，在许多重症监护病房中，每天平均需要进行11-12次测量可能是临床负担。这项研究旨在通过使用经过验证的计算机模拟患者，将STAR 1-3小时间隔延长至1至4、5和6小时间隔，并评估这些较长间隔对GC安全性和疗效的影响，从而显着减少工作量和试验方法。使用标准STAR方法可以在较长的时间间隔内实现更多的高血糖，而STAR上限控制方法可以限制营养，从而在较长的干预间隔内缓解高血糖。结果将STAR从1-3小时延长到1-6小时，几乎为两种方法的所有患者提供了高安全性和有效性。对于STAR标准，虚拟试验结果显示，随着治疗间隔的延长，在安全的4.4-8.0 mmol / L目标带中，血糖百分比降低（从83％到80％）。较长的间隔时间会导致高血糖（15％至18％BG> 8.0 mmol / L）和低血糖（最低BG <2.2 mmol / L患者的2.1％至2.8％）的风险增加。这些结果是通过胰岛素（3.2 [2.0 5.0]至2.5 [1.5 3.0] U / h略有降低）和营养（目标饲料的100 [85 100]至90 [75 100]％）的降低而实现的，但最重要的是，减少工作量（每天12到8次测量）。STAR上限控制方法可减轻高血糖症，并降低胰岛素并显着降低营养管理率。结论高血糖和低血糖的风险适度增加，以及与更长治疗间隔相关的营养输送减少，代表了GC的重大风险和回报折衷。但是，STAR仍然为几乎所有患者提供高度安全，有效的控制，无论其治疗间隔和方法如何，这表明这种独特的基于风险的给药方法（可调节胰岛素和营养）在设计上非常可靠。应当使用具有不同测量时间范围的STAR进行临床试验，以临床确认这些结果。无论治疗间隔和方法如何，几乎所有患者均可得到有效控制，这显示了这种独特的基于风险的给药方法，可调节胰岛素和营养，使其设计稳健。应当使用具有不同测量时间范围的STAR进行临床试验，以临床确认这些结果。无论治疗间隔和治疗方法如何，几乎所有患者都能得到有效控制，这显示了这种独特的基于风险的给药方法，可调节胰岛素和营养，使其设计稳健。应当使用具有不同测量时间范围的STAR进行临床试验，以临床确认这些结果。