Novo Nordisk A/S, Søborg, Denmark.
Novo Nordisk A/S, Måløv, Denmark.
Diabetes Technol Ther. 2022 Jan;24(1):10-17. doi: 10.1089/dia.2021.0199. Epub 2021 Dec 14.
In the onset 5 trial, fast-acting insulin aspart (faster aspart) was noninferior to insulin aspart (IAsp) for change from baseline glycated hemoglobin at 16 weeks, when used in continuous subcutaneous insulin infusion by participants with type 1 diabetes. The aim of this post hoc analysis was to investigate whether infusion set wear-time was associated with changes in sensor glucose, measured using continuous glucose monitoring (CGM). This was a post hoc analysis of onset 5 data. Mean infusion set wear-time and duration of CGM-wearing period were assessed. Mean CGM sensor glucose 24 h before and 24 h after were used to calculate the before-after difference (CGM sensor glucose drift). Mean infusion set wear-time was 2.9 and 3.0 days in the faster aspart and IAsp arms, respectively. At 16 weeks, the average duration of the CGM wearing period was 13.7 and 13.8 days, respectively. Mean CGM sensor glucose before versus after an infusion set change, at week 16, was 10.14 versus 9.39 mmol/L with faster aspart and 9.48 versus 9.47 mmol/L with IAsp. The estimated treatment difference in CGM sensor glucose drift at 16 weeks for faster aspart versus IAsp was +0.72 mmol/L (95% confidence interval: 0.48-0.96, < 0.001). Mean infusion set wear-time and duration of CGM-wearing period were similar for faster aspart and IAsp. A significantly greater upward drift in CGM sensor glucose values measured during an infusion set wearing period was observed with faster aspart versus IAsp. NCT02825251.
在起始 5 试验中,速效门冬胰岛素(更快门冬)在 16 周时与门冬胰岛素(IAsp)相比,在 1 型糖尿病患者连续皮下胰岛素输注时,糖化血红蛋白从基线的变化无差异。本事后分析旨在研究输注装置佩戴时间是否与使用连续血糖监测(CGM)测量的传感器葡萄糖变化有关。这是起始 5 数据的事后分析。评估了平均输注装置佩戴时间和 CGM 佩戴期的持续时间。使用 CGM 佩戴前 24 小时和后 24 小时的平均传感器葡萄糖值来计算前后差值(CGM 传感器葡萄糖漂移)。更快门冬和 IAsp 组的平均输注装置佩戴时间分别为 2.9 和 3.0 天。在 16 周时,CGM 佩戴期的平均持续时间分别为 13.7 和 13.8 天。在 16 周时,输注装置更换前后,平均 CGM 传感器葡萄糖值分别为 10.14 与 9.39mmol/L (更快门冬)和 9.48 与 9.47mmol/L (IAsp)。与 IAsp 相比,更快门冬在 16 周时 CGM 传感器葡萄糖漂移的估计治疗差异为+0.72mmol/L(95%置信区间:0.48-0.96, < 0.001)。更快门冬和 IAsp 的平均输注装置佩戴时间和 CGM 佩戴期相似。在输注装置佩戴期间测量的 CGM 传感器葡萄糖值呈明显向上漂移,更快门冬的漂移幅度明显大于 IAsp。NCT02825251。