The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.
Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins
Open accessAbstract
BACKGROUND: There are a lack of data regarding the effect of basal insulin analogues on rates of events like congenital malformation and perinatal mortality in diabetic pregnancy. METHODS: The present study is a prospective, non-interventional, multicentre cohort study conducted in seven countries, designed to assess the safety of insulin detemir during pregnancy, and to monitor the health status of resulting infants (exposed in utero) up to 1 year of age. The study population includes women with type 1 or type 2 diabetes, who are pregnant and being treated with insulin. Data will be collected in the context of routine practice. The primary endpoint is the proportion of pregnancies in women treated with insulin detemir, compared with other basal insulin regimens, which do not result in any of the following events: major congenital malformations, perinatal death or neonatal death. A sample size of 3075 pregnancies was calculated to provide an 80% power to detect a difference of 3.5% between groups in the primary endpoint at a 5% level. DISCUSSION: The study will also examine other important maternal endpoints (e.g., incidences of severe hypoglycaemia and pre-eclampsia) and perinatal outcomes such as overweight neonates, as well as infant outcomes at 1 year of age. It has a fixed recruitment period from 2013 to 2018, enrolling all eligible patients, and is expected to inform future prescribing with basal insulins in diabetic pregnancy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01892319 (date registered: 27.06.2013).
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The safety of the use of aspart and detemir analogs was confirmed in randomized trials.
“The safety of the use of aspart and detemir analogs was confirmed in randomized trials [104,105,106]”
From Gestational Diabetes Mellitus—Recent Literature Review (2022) · cites this paper as [105]
The Background reports one randomized trial comparing detemir with NPH insulin, both given with insulin aspart, and says it suggested similar tolerability for perinatal outcomes. That supports a qualified safety statement about detemir, but the trial did not independently establish aspart’s safety, and the paper says the trial was too small to assess rare outcomes such as malformations and perinatal or neonatal death. (LLM, conf=0.88)
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Outcomes in Type 1 Diabetic Pregnancies
Jensen, D. M., Damm, P., Moelsted-Pedersen, L., Ovesen, P., Westergaard, J. G., Moeller, M., & Beck-Nielsen, H. (2004) · Diabetes Care · doi:10.2337/diacare.27.12.2819 · Cited by 486
Self-citationSuhonen, L., Hiilesmaa, V., & Teramo, K. (2000) · Diabetologia · doi:10.1007/s001250050010 · Cited by 302
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Research works printed but not linked: 14
- Persson M, Norman M, Hanson U. Obstetric and perinatal outcomes in type 1 diabetic pregnancies: A large, population-based study. Diabetes Care. 2009;32:2005–9. · DOI
- Eidem I, Stene LC, Henriksen T, Hanssen KF, Vangen S, Vollset SE, Joner G. Congenital anomalies in newborns of women with type 1 diabetes: nationwide population-based study in Norway, 1999–2004. Acta Obstet Gynecol Scand. 2010;89:1403–11. · DOI
- Eidem I, Vangen S, Hanssen KF, Vollset SE, Henriksen T, Joner G, Stene LC. Perinatal and infant mortality in term and preterm births among women with type 1 diabetes. Diabetologia. 2011;54:2771–8. · DOI
- Mathiesen ER, Damm P, Jovanovic L, McCance DR, Thyregod C, Jensen AB, Hod M. Basal insulin analogues in diabetic pregnancy: a literature review and baseline results of a randomised, controlled trial in type 1 diabetes. Diabetes Metab Res Rev. 2011;27:543–51. · DOI · Paper page
- Callesen NF, Damm J, Mathiesen JM, Ringholm L, Damm P, Mathiesen ER. Treatment with the long-acting insulin analogues detemir or glargine during pregnancy in women with type 1 diabetes: comparison of glycaemic control and pregnancy outcome. J Matern Fetal Neonatal Med. 2013;26:588–92. · DOI
- Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brøndsted L, Jovanovic L, Damm P, McCance DR, Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012;35:2012–7. · DOI · Paper page
- Hod M, Mathiesen ER, Jovanovič L, McCance DR, Ivanisevic M, Durán-Garcia S, Brøndsted L, Nazeri A, Damm P. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J Matern Fetal Neonatal Med. 2014;27:7–13. · DOI · Paper page
- Macintosh MC, Fleming KM, Bailey JA, Doyle P, Modder J, Acolet D, Golightly S, Miller A. Perinatal mortality and congenital anomalies in babies of women with type 1 or type 2 diabetes in England, Wales, and Northern Ireland: population based study. BMJ. 2006;333:177. · DOI · Paper page
- Evers IM, de Valk HW, Visser GH. Risk of complications of pregnancy in women with type 1 diabetes: nationwide prospective study in the Netherlands. BMJ. 2004;328:915. · DOI
- Günter HH, Scharf A, Hertel H, Hillemanns P, Wenzlaff P, Maul H. Perinatal morbidity in pregnancies of women with preconceptional and gestational diabetes mellitus in comparison with pregnancies of non-diabetic women. Results of the perinatal registry of Lower Saxony, Germany]. [Article in German]. Z Geburtshilfe Neonatol. 2006;210:200–7. · DOI
- Mathiesen ER, Ringholm L, Damm P. Stillbirth in diabetic pregnancies. Best Pract Res Clin Obstet Gynaecol. 2011;25:105–11. · DOI
- Monami M, Marchionni N, Mannucci E. Long-acting insulin analogues versus NPH human insulin in type 2 diabetes: a meta-analysis. Diabetes Res Clin Pract. 2008;81:184–9. · DOI · Paper page
- Monami M, Marchionni N, Mannucci E. Long-acting insulin analogues vs. NPH human insulin in type 1 diabetes. A meta-analysis. Diabetes Obes Metab. 2009;11:372–8. · DOI
- Ringholm L, Pedersen-Bjergaard U, Thorsteinsson B, Damm P, Mathiesen ER. Hypoglycaemia during pregnancy in women with type 1 diabetes. Diabetic Med. 2012;29:558–66. · DOI · Paper page
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Gestational Diabetes Mellitus—Recent Literature Review
Modzelewski, R., Stefanowicz-Rutkowska, M. M., Matuszewski, W., & Bandurska-Stankiewicz, E. M. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11195736 · Cited by 223
Benhalima, K., Mathiesen, E. R., Paldanius, P. M., & Mathieu, C. (2018) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.13386 · Cited by 4
Self-citation
Metadata
- Authors
- Mathiesen, E. R., Andersen, H., Kring, S. I. I., & Damm, P.
- Affiliations
- University of Copenhagen (DK)
- Novo Nordisk (Denmark) (DK)
- Corresponding author
- Mathiesen, Elisabeth R.
- Venue
- BMC Pregnancy and Childbirth
- Published
- 2017-01-18
- Volume
- 17
- Issue
- 1
- Pages
- 38-38
- ISSN
- 1471-2393 (ISSN-L)
- PMC
- PMC5241954
- OpenAlex
- W2572474416
- Cited by
- 12
- References
- 2
- Citations by year
- 2024: 1 · 2023: 2 · 2022: 3 · 2021: 3 · 2018: 3
- FWCI
- 0.97
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- BMC Pregnancy and Childbirth (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by)
- Funders
- Novo Nordisk
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- insulin detemir, diabetes in pregnancy, type 1 diabetes, type 2 diabetes, congenital malformations, perinatal mortality, neonatal death, basal insulin analogues, insulin safety, severe hypoglycemia, preeclampsia, infant outcomes
- MeSH terms
- Abnormalities, Drug-Induced, Insulin Detemir, Adult, Diabetes Mellitus, Female, Humans, Hypoglycemic Agents, Infant, Newborn, Pregnancy, Pregnancy in Diabetics, Prospective Studies, Research Design, Perinatal Death
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