Søholm Julie C, Nørgaard Sidse K, Nørgaard Kirsten, Clausen Tine D, Damm Peter, Mathiesen Elisabeth R, Ringholm Lene
Center for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark.
Department of Nephrology and Endocrinology, Rigshospitalet, Copenhagen, Denmark.
Diabet Med. 2025 Jan;42(1):e15467. doi: 10.1111/dme.15467. Epub 2024 Nov 4.
We compared sensor-derived glycaemic metrics in pregnant women with type 1 diabetes (T1D) randomised to faster acting insulin aspart (faster aspart) or insulin aspart (IAsp).
A pre-planned secondary analysis of the CopenFast trial included women with T1D using intermittently scanned continuous glucose monitoring (isCGM) during pregnancy. Glycaemic metrics, including time in range (TIRp, 3.5-7.8 mmol/L) and time below range in pregnancy (TBRp, <3.5 mmol/L), were evaluated in the intervals: from randomisation (median 9.5 weeks, interquartile range 9.0-11.0) to 21 weeks, from 22 to 33 weeks and from 34 to 37 weeks.
In total, 113 (91%) of 124 women using isCGM in the original trial were included. At randomisation, glycaemic metrics were comparable in both groups. Women randomised to faster aspart achieved higher TIRp from 22 to 33 weeks (estimated treatment difference 5.1% [95% confidence interval 0.3; 9.7], p = 0.04) and mean TIRp >70% from randomisation to 21 weeks onwards, while this was achieved after 34 weeks in women randomised to IAsp. TBRp remained stable around 4% throughout pregnancy in both groups. One (2%) versus 5 (9%) experienced ≥1 severe hypoglycaemic event (odds ratio 0.93 [-0.2; -0.01], p = 0.04). Infant birthweight standard deviation score was lower in the faster aspart group (estimated treatment difference -0.5 [-0.9; -0.03], p = 0.04); however, this attenuated when adjusting for parity (p = 0.10).
Women using faster aspart achieved more TIRp and experienced less severe hypoglycaemia compared to women using IAsp. Infant birthweight was lower and thereby more appropriate in the faster aspart group; however, this attenuated when adjusting for parity.
我们比较了随机分配至使用速效门冬胰岛素（更快起效门冬胰岛素）或门冬胰岛素（IAsp）的1型糖尿病（T1D）孕妇中传感器衍生的血糖指标。
对CopenFast试验进行的一项预先计划的二次分析纳入了在孕期使用间歇性扫描式动态血糖监测（isCGM）的T1D女性。在以下时间段评估血糖指标，包括血糖达标时间（TIRp，3.5 - 7.8 mmol/L）和孕期血糖低于范围的时间（TBRp，<3.5 mmol/L）：从随机分组（中位数9.5周，四分位间距9.0 - 11.0）至21周、从22至33周以及从34至37周。
原始试验中使用isCGM的124名女性中，共有113名（91%）被纳入。随机分组时，两组的血糖指标具有可比性。随机分配至更快起效门冬胰岛素组的女性在22至33周时达到了更高的TIRp（估计治疗差异5.1% [95%置信区间0.3；9.7]，p = 0.04），并且从随机分组至21周及之后平均TIRp >70%，而随机分配至IAsp组的女性在34周后才达到这一水平。两组在整个孕期TBRp均稳定在4%左右。1名（2%）与5名（9%）发生了≥1次严重低血糖事件（比值比0.93 [-0.2；-0.01]，p = 0.04）。更快起效门冬胰岛素组婴儿出生体重标准差评分更低（估计治疗差异-0.5 [-0.9；-0.03]，p = 0.04）；然而，在调整胎次后这种差异减弱（p = 0.10）。
与使用IAsp的女性相比，使用更快起效门冬胰岛素的女性达到了更多的TIRp且发生严重低血糖的情况更少。更快起效门冬胰岛素组婴儿出生体重更低，因此更合适；然而，在调整胎次后这种差异减弱。
