Medtronic International Trading Sàrl, Tolochenaz, Switzerland.
Diabetes Research Institute, IRCCS San Raffaele Hospital and San Raffaele Vita Salute University, Milan, Italy.
Diabetes Obes Metab. 2021 Aug;23(8):1942-1949. doi: 10.1111/dom.14424. Epub 2021 May 27.
To evaluate the real-world performance of the MiniMed 670G system in Europe, in individuals with diabetes.
Data uploaded from October 2018 to July 2020 by individuals living in Europe were aggregated and retrospectively analysed. The mean glucose management indicator (GMI), percentage of time spent within (TIR), below (TBR) and above (TAR) glycaemic ranges, system use and insulin consumed in users with 10 or more days of sensor glucose data after initial Auto Mode start were determined. Another analysis based on suboptimally (GMI > 8.0%) and well-controlled (GMI < 7.0%) glycaemia pre-Auto Mode initiation was also performed.
Users (N = 14 899) spent a mean of 81.4% of the time in Auto Mode and achieved a mean GMI of 7.0% ± 0.4%, TIR of 72.0% ± 9.7%, TBR less than 3.9 mmol/L of 2.4% ± 2.1% and TAR more than 10 mmol/L of 25.7% ± 10%, after initiating Auto Mode. When compared with pre-Auto Mode initiation, GMI was reduced by 0.3% ± 0.4% and TIR increased by 9.6% ± 9.9% (P < .0001 for both). Significantly improved glycaemic control was observed irrespective of pre-Auto Mode GMI levels of less than 7.0% or of more than 8.0%. While the total daily dose of insulin increased for both groups, a greater increase was observed in the latter, an increase primarily due to increased basal insulin delivery. By contrast, basal insulin decreased slightly in well-controlled users.
Most MiniMed 670G system users in Europe achieved TIR more than 70% and GMI less than 7% while minimizing hypoglycaemia, in a real-world environment. These international consensus-met outcomes were enabled by automated insulin delivery meeting real-time insulin requirements adapted to each individual user.
评估 MiniMed 670G 系统在欧洲的真实世界性能,针对糖尿病患者。
汇总并回顾性分析了 2018 年 10 月至 2020 年 7 月期间居住在欧洲的个人上传的数据。确定了初始自动模式启动后 10 天或以上有传感器血糖数据的使用者中,平均血糖管理指标(GMI)、时间百分比(TIR)、时间百分比(TBR)、时间百分比(TAR)、系统使用和胰岛素消耗。还基于自动模式启动前血糖控制不理想(GMI > 8.0%)和控制良好(GMI < 7.0%)进行了另一个分析。
使用者(N=14899)平均 81.4%的时间处于自动模式,平均 GMI 为 7.0%±0.4%,TIR 为 72.0%±9.7%,TBR 小于 3.9mmol/L 为 2.4%±2.1%,TAR 大于 10mmol/L 为 25.7%±10%,在启动自动模式后。与自动模式启动前相比,GMI 降低了 0.3%±0.4%,TIR 增加了 9.6%±9.9%(均<.0001)。无论自动模式启动前的 GMI 水平是否低于 7.0%或高于 8.0%,均观察到血糖控制明显改善。虽然两组的胰岛素总日剂量均增加,但后者增加幅度更大,这主要是由于基础胰岛素剂量增加。相比之下,血糖控制良好的使用者基础胰岛素略有下降。
在真实环境中,大多数欧洲的 MiniMed 670G 系统使用者实现了 TIR 超过 70%和 GMI 低于 7%,同时最大限度地减少了低血糖。这些符合国际共识的结果是通过满足每个个体用户实时胰岛素需求的自动胰岛素输送实现的。