Introduction

Medtronic has developed a virtual patient simulator for modeling and predicting insulin therapy outcomes for people with type 1 diabetes (T1D). An enhanced simulator was created to estimate outcomes when using the MiniMed^TM 670G system with standard NovoLog® (EU: NovoRapid, US: NovoLog) versus Fiasp ® by using clinical data.

Methods

Sixty-seven participants' PK profiles were generated per type of insulin (Total of 134 PK profiles). 7,485 virtual patients' PK measurements was matched with one of the 67 NovoLog® PK Tmax values. These 7,485 virtual patients were then simulated using the Medtronic MiniMed™ 670G algorithm following an in-silico protocol of 90 days: 14 days in open loop (Manual Mode) followed by 76 days in closed loop (Auto Mode). Simulation study was repeated with each NovoLog® PK profile being replaced by its corresponding Fiasp® PK profile in the same virtual patient. To validate our in-silico analysis, we compared the results of “actual” 19 “real life” patients from a clinical study

Results

Simulated overall and postprandial glycemic outcomes improved in all age groups with Fiasp®. The percentage of time in the euglycemic range increased by about ~2.2% with Fiasp®, in all age groups (p < 0.01). The percentage of time spent at <70 mg/dL was reduced by about ~0.6% with insulin Fiasp® (p < 0.01) and the mean glucose was reduced by about 1.3 mg/dL (p < 0.01), excluding those age <7 years. The simulated mean postprandial SG was reduced by ~5 mg/dL, a significant difference for all age groups. A clinical study results showed similar improvements with MiniMed^TM 670G system when switching from NovoLog® to Fiasp®.

Conclusions

The simulation studies indicate that using Fiasp® in place of NovoLog® with the MiniMed^TM 670G system will significantly improve the time spent in the healthy, euglycemic range and reduce exposure to hyperglycemia and hypoglycemia in most patients.

中文翻译：

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与NovoLog®相比，在模拟试验中与MiniMed ^TM 670G混合闭环系统一起使用时，速效门冬胰岛素（Fiasp®）可改善血糖结果

介绍

美敦力（Medtronic）开发了一种虚拟的患者模拟器，用于为1型糖尿病（T1D）患者建模和预测胰岛素治疗的结果。通过使用临床数据，创建了增强型模拟器来估计将MiniMed ^TM 670G系统与标准NovoLog®（欧盟：NovoRapid，美国：NovoLog）对比Fiasp®时的效果。

方法

每种胰岛素生成67位参与者的PK曲线（总共134个PK曲线）。7,485名虚拟患者的PK测量值与67个NovoLog®PK Tmax值之一匹配。然后，使用Medtronic MiniMed™670G算法按照90天的计算机内协议对这7485名虚拟患者进行了模拟：在开环（手动模式）下为14天，然后在闭环（自动模式）下为76天。重复模拟研究，在同一虚拟患者中，将每个NovoLog®PK配置文件替换为其相应的Fiasp®PK配置文件。为了验证我们的计算机分析，我们比较了一项临床研究中的“实际” 19名“现实生活”患者的结果

结果

Fiasp®在所有年龄段的模拟总体和餐后血糖结果均得到改善。在所有年龄段中，Fiasp®在正常血糖范围内的时间百分比增加了约2.2％（p <0.01）。使用胰岛素Fiasp®时，在<70 mg / dL上花费的时间百分比减少了约〜0.6％（p <0.01），而平均年龄在7岁以下的人，平均葡萄糖减少了约1.3 mg / dL（p <0.01）。年。餐后SG的模拟平均值降低了〜5 mg / dL，在所有年龄组中均存在显着差异。临床研究结果表明，从NovoLog®切换到Fiasp®时，MiniMed ^TM 670G系统具有类似的改进。

结论

仿真研究表明，在MiniMed ^TM 670G系统上使用Fiasp®代替NovoLog®可以显着改善在健康，正常血糖范围内花费的时间，并减少大多数患者的高血糖和低血糖暴露。