{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,29]],"date-time":"2025-11-29T16:26:10Z","timestamp":1764433570609,"version":"3.41.2"},"reference-count":29,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,8,8]],"date-time":"2024-08-08T00:00:00Z","timestamp":1723075200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabet Med"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>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\u2010world setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a post hoc analysis of a prospective cohort study of 1840 pregnant women with T1D, treated with IAsp (<jats:italic>n<\/jats:italic>\u2009=\u20091434) or other bolus insulins (<jats:italic>n<\/jats:italic>\u2009=\u2009406) 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<jats:sub>1c<\/jats:sub> values measured immediately before and during pregnancy and major hypoglycaemia, as well as abortion, pre\u2010eclampsia, pre\u2010term delivery, large for gestational age at birth, stillbirth and fetal malformations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats: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\u2010adjusted analyses. However, maternal HbA<jats:sub>1c<\/jats:sub> was lower in the IAsp group at the end of the third trimester (adjusted difference, \u22120.16% point [95% CI \u22120.28;\u22120.05]; \u22121.8\u2009mmol\/mol [95% CI \u22123.1;\u22120.6]; <jats:italic>p<\/jats:italic>\u2009=\u20090.0046).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats: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<jats:sub>1c<\/jats:sub> with IAsp in late pregnancy should be confirmed in other studies.<\/jats:p><\/jats:sec>","DOI":"10.1111\/dme.15411","type":"journal-article","created":{"date-parts":[[2024,8,8]],"date-time":"2024-08-08T11:40:36Z","timestamp":1723117236000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A comparison of the safety and effectiveness of insulin aspart with other bolus insulins in women with pre\u2010existing Type 1 diabetes during pregnancy: A post hoc analysis of a prospective cohort study"],"prefix":"10.1111","volume":"41","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3279-0863","authenticated-orcid":false,"given":"Elisabeth R.","family":"Mathiesen","sequence":"first","affiliation":[{"name":"Center for Pregnant Women with Diabetes Department of Endocrinology  Copenhagen Denmark"},{"name":"Department of Clinical Medicine University of Copenhagen  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amra Ciric","family":"Alibegovic","sequence":"additional","affiliation":[{"name":"Medical and Science, Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gayathri","family":"Anil","sequence":"additional","affiliation":[{"name":"Global Medical Affairs, Global Business Services (GMA\u2010GBS), Novo Nordisk Service Centre India Private Limited  Bengaluru India"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3682-9403","authenticated-orcid":false,"given":"Fidelma","family":"Dunne","sequence":"additional","affiliation":[{"name":"College of Medicine Nursing and Health Sciences, National University of Ireland Galway  Galway Ireland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tariq","family":"Halasa","sequence":"additional","affiliation":[{"name":"Real\u2010World Science\u2014Diabetes, Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marina","family":"Ivani\u0161evi\u0107","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology State Referral Center for Diabetes in Pregnancy, Clinical Hospital Center Zagreb  Zagreb Croatia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David R.","family":"McCance","sequence":"additional","affiliation":[{"name":"Metabolic Unit, Royal Victoria Hospital  Belfast UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rikke Baastrup","family":"Nordsborg","sequence":"additional","affiliation":[{"name":"Data Science, Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Damm","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine University of Copenhagen  Copenhagen Denmark"},{"name":"Center for Pregnant Women with Diabetes, Department of Gynaecology, Fertility and Obstetrics  Copenhagen Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the EVOLVE study group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,8,8]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"International Diabetes Federation.IDF Diabetes Atlas 10th edition.2021Accessed January 20 2023.https:\/\/www.diabetesatlas.org\/"},{"key":"e_1_2_13_3_1","unstructured":"Centers for Disease Control and Prevention.Diabetes during Pregnancy.2018Accessed January 20 2023.https:\/\/www.cdc.gov\/reproductivehealth\/maternalinfanthealth\/diabetes\u2010during\u2010pregnancy.htm#:~:text=Diabetes%20during%20pregnancy%E2%80%94including%20type 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