Medtronic Diabetes, United States.
Medtronic Diabetes, United States.
Comput Methods Programs Biomed. 2021 Jun;205:106087. doi: 10.1016/j.cmpb.2021.106087. Epub 2021 Apr 8.
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 670G system with standard NovoLog® (EU: NovoRapid, US: NovoLog) versus Fiasp ® by using clinical data.
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 670G system when switching from NovoLog® to Fiasp®.
The simulation studies indicate that using Fiasp® in place of NovoLog® with the MiniMed 670G system will significantly improve the time spent in the healthy, euglycemic range and reduce exposure to hyperglycemia and hypoglycemia in most patients.
美敦力为 1 型糖尿病（T1D）患者的胰岛素治疗结果建模和预测开发了一种虚拟患者模拟器。使用临床数据创建了一个增强型模拟器，以估计使用美敦力 MiniMed 670G 系统与标准诺和锐（欧盟：诺和锐速，美国：诺和锐）时的结果。
为每种胰岛素生成 67 名参与者的 PK 曲线（共 134 条 PK 曲线）。7485 名虚拟患者的 PK 测量值与诺和锐®Tmax 值中的 67 个值之一相匹配。然后，使用美敦力 MiniMed™670G 算法对这 7485 名虚拟患者进行模拟，遵循 90 天的模拟方案：14 天开环（手动模式），随后 76 天闭环（自动模式）。使用相同的虚拟患者，用每种诺和锐®PK 曲线替换其相应的法地特®PK 曲线，重复模拟研究。为了验证我们的计算机分析，我们将临床研究中“实际”的 19 名“真实生活”患者的结果与模拟结果进行了比较。
法地特®可改善所有年龄段患者的总体和餐后血糖结果。所有年龄段患者的血糖控制达标时间（euglycemic range）增加了约 2.2%（p<0.01）。使用胰岛素法地特®，血糖<70mg/dL 的时间减少了约 0.6%（p<0.01），并且平均血糖降低了约 1.3mg/dL（p<0.01），不包括年龄<7 岁的患者。模拟餐后平均血糖降低了约 5mg/dL，这对所有年龄段都是显著差异。一项临床研究结果表明，当从诺和锐®切换到法地特®时，MiniMed 670G 系统的临床结果也有类似的改善。
模拟研究表明，在 MiniMed 670G 系统中使用法地特®代替诺和锐®将显著改善大多数患者的健康、血糖控制达标时间，并减少高血糖和低血糖暴露。
