Elisabeth R. Mathiesen, Amra Ciric Alibegovic, Gayathri Anil, Fidelma Dunne, Tariq Halasa, Marina Ivanišević, David R. McCance, Rikke Baastrup Nordsborg, Peter Damm, the EVOLVE study group
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The aim of this study was to assess glycaemic control and safety of IAsp versus other bolus insulins in Type 1 diabetic pregnancy in a real-world setting.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>This was a post hoc analysis of a prospective cohort study of 1840 pregnant women with T1D, treated with IAsp (<i>n</i> = 1434) or other bolus insulins (<i>n</i> = 406) in the Diabetes Pregnancy Registry. The primary (composite) outcome was the proportion of pregnancies resulting in major congenital malformations or perinatal or neonatal death. Secondary outcomes included all HbA<sub>1c</sub> values measured immediately before and during pregnancy and major hypoglycaemia, as well as abortion, pre-eclampsia, pre-term delivery, large for gestational age at birth, stillbirth and fetal malformations.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>There were no significant differences found in any of the pregnancy outcomes between treatment with IAsp and other bolus insulins in either the crude or propensity score-adjusted analyses. However, maternal HbA<sub>1c</sub> was lower in the IAsp group at the end of the third trimester (adjusted difference, −0.16% point [95% CI −0.28;−0.05]; −1.8 mmol/mol [95% CI −3.1;−0.6]; <i>p</i> = 0.0046).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>No significant differences in safety or pregnancy outcomes were demonstrated when comparing treatment with IAsp versus other bolus insulins in women with T1D during pregnancy. The observed improvement in HbA<sub>1c</sub> with IAsp in late pregnancy should be confirmed in other studies.</p>\n </section>\n </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":null,"pages":null},"PeriodicalIF":3.2000,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.15411","citationCount":"0","resultStr":"{\"title\":\"A comparison of the safety and effectiveness of insulin aspart with other bolus insulins in women with pre-existing Type 1 diabetes during pregnancy: A post hoc analysis of a prospective cohort study\",\"authors\":\"Elisabeth R. Mathiesen, Amra Ciric Alibegovic, Gayathri Anil, Fidelma Dunne, Tariq Halasa, Marina Ivanišević, David R. 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引用次数: 0
摘要
目的：在一项随机临床试验中，1 型糖尿病（T1D）孕妇使用的胰岛素类似物天冬胰岛素（IAsp）的安全性和有效性已得到证实，IAsp 在孕期得到广泛应用。本研究的目的是在实际环境中评估 1 型糖尿病孕妇使用 IAsp 与其他栓剂胰岛素的血糖控制情况和安全性：这是一项前瞻性队列研究的事后分析，研究对象是糖尿病妊娠登记处的1840名T1D孕妇，她们接受了IAsp（1434人）或其他栓剂胰岛素（406人）治疗。主要（复合）结果是导致重大先天性畸形或围产期或新生儿死亡的妊娠比例。次要结果包括孕前和孕期测量的所有 HbA1c 值、严重低血糖、流产、先兆子痫、早产、胎龄过大、死胎和胎儿畸形：无论是粗略分析还是倾向得分调整分析，均未发现使用IAsp和其他栓剂胰岛素治疗的妊娠结局有明显差异。然而，IAsp组孕妇在妊娠三个月结束时的HbA1c较低（调整后差异为-0.16%点[95% CI -0.28;-0.05]；-1.8 mmol/mol [95% CI -3.1;-0.6]；P = 0.0046）：妊娠期T1D妇女使用IAsp治疗与使用其他栓剂胰岛素治疗相比，在安全性和妊娠结局方面没有明显差异。在妊娠晚期使用IAsp可改善HbA1c，这一点应在其他研究中得到证实。
A comparison of the safety and effectiveness of insulin aspart with other bolus insulins in women with pre-existing Type 1 diabetes during pregnancy: A post hoc analysis of a prospective cohort study
Aims
The safety and efficacy of insulin analogue insulin aspart (IAsp) have been demonstrated in a randomised clinical trial in pregnant women with Type 1 diabetes (T1D), and IAsp is widely used during pregnancy. The aim of this study was to assess glycaemic control and safety of IAsp versus other bolus insulins in Type 1 diabetic pregnancy in a real-world setting.
Methods
This was a post hoc analysis of a prospective cohort study of 1840 pregnant women with T1D, treated with IAsp (n = 1434) or other bolus insulins (n = 406) in the Diabetes Pregnancy Registry. The primary (composite) outcome was the proportion of pregnancies resulting in major congenital malformations or perinatal or neonatal death. Secondary outcomes included all HbA1c values measured immediately before and during pregnancy and major hypoglycaemia, as well as abortion, pre-eclampsia, pre-term delivery, large for gestational age at birth, stillbirth and fetal malformations.
Results
There were no significant differences found in any of the pregnancy outcomes between treatment with IAsp and other bolus insulins in either the crude or propensity score-adjusted analyses. However, maternal HbA1c was lower in the IAsp group at the end of the third trimester (adjusted difference, −0.16% point [95% CI −0.28;−0.05]; −1.8 mmol/mol [95% CI −3.1;−0.6]; p = 0.0046).
Conclusions
No significant differences in safety or pregnancy outcomes were demonstrated when comparing treatment with IAsp versus other bolus insulins in women with T1D during pregnancy. The observed improvement in HbA1c with IAsp in late pregnancy should be confirmed in other studies.
期刊介绍：
Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions.
The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed.
We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services.
Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”
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