Jotic Aleksandra, Milicic Tanja, Lalic Katarina, Lukic Ljiljana, Macesic Marija, Stanarcic Gajovic Jelena, Stoiljkovic Milica, Gojnic Dugalic Miroslava, Jeremic Veljko, Lalic Nebojsa M
Clinic for Endocrinology, Diabetes and Metabolic Diseases, Clinical Center of Serbia, Dr. Subotića 13, 11000, Belgrade, Serbia.
Faculty of Medicine, University of Belgrade, Dr. Subotića 8, 11000, Belgrade, Serbia.
Diabetes Ther. 2020 Apr;11(4):845-858. doi: 10.1007/s13300-020-00780-7. Epub 2020 Feb 15.
We evaluated the effectiveness of long-term continuous subcutaneous insulin infusion (CSII) compared with multiple daily insulin (MDI) injections for glycaemic control and variability, hypoglycaemic episodes and maternal/neonatal outcomes in pregnant women with pre-existing type 1 diabetes (pT1D).
Our observational cohort study included 128 consecutive pregnant women with pT1D, who were treated from 1 January 2010 to 31 December 2017. Of 128 participants, 48 were on CSII and 80 were on MDI. Glycaemic control was determined by glycated haemoglobin (HbA1c) (captured in preconception and each trimester of pregnancy). Glucose variability (GV) was expressed as the coefficient of variation (CV) [calculated from self-monitoring of blood glucose (SMBG) values], and hypoglycaemia was defined as glucose values < 3.9 mmol/l. The data on maternal and neonatal outcomes were collected from obstetrical records.
Duration of the treatment was 8.8 ± 5.3 years in the CSII and 12.6 ± 8.0 years in the MDI group. The CSII lowered HbA1c in preconception (7.1 ± 0.1 vs. 7.9 ± 0.2%, p = 0.03) and the first (6.9 ± 0.1 vs. 7.7 ± 0.2%, p = 0.02), second (6.6 ± 0.1 vs. 7.2 ± 0.1%, p = 0.003) and third (6.5 ± 0.1 vs. 6.8 ± 0.1%, p = 0.02) trimesters significantly better than MDI. Significantly lower CV was observed only for fasting glycaemia in the first trimester (17.1 vs 28.4%, p < 0.001) in favour of CSII. Moreover, the CSII group had significantly lower mean hypoglycaemic episodes/week/patient only during the first trimester (2.0 ± 1.7 vs 4.8 ± 1.5, p < 0.01). In early pregnancy, the majority of women on CSII had less hypoglycaemia than on MDI (0-3: 79.1 vs. 29.1%; 4-6: 18.8 vs. 65.8%; ≥ 7: 2.1 vs. 5.1%, p < 0.01, respectively). We found no difference in the incidence of adverse maternal/neonatal outcomes.
Treatment with CSII resulted in a favourable reduction of HbA1c in the preconception period and each trimester in pregnancy. Moreover, long-term CSII treatment demonstrated more stable metabolic control with less GV of fasting glycaemia and fewer hypoglyacemic episodes only during early pregnancy.
我们评估了长期持续皮下胰岛素输注（CSII）与多次每日胰岛素（MDI）注射相比，对患有1型糖尿病（pT1D）的孕妇进行血糖控制、血糖变异性、低血糖发作以及母婴结局的有效性。
我们的观察性队列研究纳入了128例连续的患有pT1D的孕妇，她们在2010年1月1日至2017年12月31日期间接受治疗。在128名参与者中，48人采用CSII治疗，80人采用MDI治疗。血糖控制通过糖化血红蛋白（HbA1c）来确定（在孕前及孕期各阶段采集）。血糖变异性（GV）以变异系数（CV）表示[根据自我血糖监测（SMBG）值计算]，低血糖定义为血糖值<3.9 mmol/L。母婴结局数据从产科记录中收集。
CSII组的治疗时长为8.8±5.3年，MDI组为12.6±8.0年。CSII在孕前（7.1±0.1%对7.9±0.2%，p = 0.03）、孕早期（6.9±0.1%对7.7±0.2%，p = 0.02）、孕中期（6.6±0.1%对7.2±0.1%，p = 0.003）和孕晚期（6.5±0.1%对6.8±0.1%，p = 0.02）显著降低HbA1c水平，优于MDI组。仅在孕早期观察到空腹血糖的CV显著更低（17.1%对28.4%，p<0.001），支持CSII治疗。此外，CSII组仅在孕早期平均每周每位患者的低血糖发作次数显著更低（2.0±1.7次对4.8±1.5次，p<0.01）。在孕早期，大多数采用CSII治疗的女性低血糖情况比采用MDI治疗时更少（0 - 3次：79.1%对29.1%；4 - 6次：18.8%对65.8%；≥7次：2.1%对5.1%，p均<0.01）。我们发现母婴不良结局的发生率没有差异。
CSII治疗在孕前及孕期各阶段均能有效降低HbA1c水平。此外，长期CSII治疗显示出更稳定的代谢控制，空腹血糖的GV更小，且仅在孕早期低血糖发作次数更少。
