Diabetes Center for Children and Adolescents, Children's Hospital on the Bult, Hanover Medical School, Hanover, Germany.
Novo Nordisk Pharma GmbH, Mainz, Germany.
Diabetes Technol Ther. 2021 Mar;23(3):203-212. doi: 10.1089/dia.2020.0360. Epub 2020 Oct 21.
The GoBolus study investigated the real-world effectiveness of faster aspart in patients with type 1 diabetes (T1D) using intermittent-scanning continuous glucose monitoring (iscCGM) systems. This 24-week, multicenter, single-arm, noninterventional study investigated adults with T1D (HbA, 7.5%-9.5%) receiving multiple daily injections (MDI) of insulin and using iscCGM within local healthcare settings for ≥6 months before switching to faster aspart at study start (week 0; baseline). Primary endpoint was HbA change from baseline to week 24. Exploratory endpoint was change in iscCGM metrics from baseline to week 24. Overall, 243 patients were included (55.6% male), with mean age/diabetes duration, 49.9/18.8 years; mean HbA, 8.1%. By week 24, HbA had decreased by 0.19% (-2.1 mmol/mol, < 0.0001) with no mean change in insulin doses or basal/bolus insulin ratios. For patients with sufficient available iscCGM data ( = 92): "time in range" (TIR; 3.9-10.0 mmol/L) increased from 46.9% to 50.1% ( = 0.01), corresponding to an increase of 46.1 min/day; time in hyperglycemia decreased from 49.1% to 46.1% (>10.0 mmol/L, = 0.026) and 20.4% to 17.9% (>13.9 mmol/L, = 0.013), corresponding to 43.5 ( = 0.024) and 35.6 ( = 0.015) fewer minutes per day on average spent in these ranges, respectively; no change for time in hypoglycemia (<3.9 and <3.0 mmol/L). Mean interstitial and postprandial glucose improved from 10.4 to 10.1 mmol/L ( = 0.035) and 11.9 to 11.0 mmol/L ( = 0.002), respectively. Real-world switching to faster aspart in adults with T1D on MDI improved HbA, increased TIR, and decreased time in hyperglycemia without affecting time in hypoglycemia. The GoBolus study: NCT03450863.
GoBolus 研究使用间歇性扫描连续血糖监测(iscCGM)系统,调查了 1 型糖尿病(T1D)患者中更快门冬胰岛素的真实世界疗效。这是一项为期 24 周、多中心、单臂、非干预性研究,共纳入 243 例接受多次每日注射(MDI)胰岛素治疗且在研究开始时(第 0 周;基线)切换至更快门冬胰岛素前,使用 iscCGM 至少 6 个月的 T1D 成年患者。主要终点为从基线到第 24 周的 HbA 变化。探索性终点为从基线到第 24 周 iscCGM 指标的变化。总体而言,243 例患者入组(55.6%为男性),平均年龄/糖尿病病程为 49.9/18.8 岁;平均 HbA 为 8.1%。至第 24 周时,HbA 下降了 0.19%(-2.1mmol/mol, < 0.0001),胰岛素剂量或基础/餐时胰岛素比例无明显变化。对于有足够可用 iscCGM 数据的患者( = 92):“血糖控制达标时间”(TIR;3.9-10.0mmol/L)从 46.9%增加至 50.1%( = 0.01),对应于每天增加 46.1 分钟;高血糖时间从 49.1%降至 46.1%(>10.0mmol/L, = 0.026)和 20.4%降至 17.9%(>13.9mmol/L, = 0.013),分别对应于平均每天减少 43.5( = 0.024)和 35.6( = 0.015)分钟;低血糖时间无变化(<3.9 和 <3.0mmol/L)。平均间质和餐后血糖分别从 10.4 降至 10.1mmol/L( = 0.035)和 11.9 降至 11.0mmol/L( = 0.002)。在接受 MDI 治疗的 T1D 成年患者中,真实世界中切换至更快门冬胰岛素可改善 HbA,增加 TIR,并减少高血糖时间,而不影响低血糖时间。GoBolus 研究:NCT03450863。