Characteristics of pregnant women with diabetes using injectable glucose-lowering drugs in the EVOLVE study
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Aims: To examine clinical parameters, glycemic control, folic acid supplementation, and the presence of other chronic diseases during early pregnancy in the EVOLVE study population (women with pre-existing diabetes treated with injectable glucose-lowering drugs). Methods: Cross-sectional baseline evaluation of EVOLVE: an international, multicenter, non-interventional study investigating the safety of injectable glucose-lowering drugs in pregnant women with pre-existing type 1 (T1D) or type 2 diabetes (T2D). Data were collected at enrollment visit interviews before gestational week 16. Results: In total, 2383 women from 17 mainly European countries were enrolled in the study: 2122 with T1D and 261 with T2D; mean age was 31 and 33 years, and duration of diabetes was 15 and 6 years, respectively. For women with T1D or T2D, 63% and 75%, respectively, received basal and rapid-acting insulin, 36% and 3% rapid-acting insulin only, 0.7% and 14.0% basal insulin only, 0.2% and 5.4% premix insulin, 0.0% and 1.2% injectable glucagon-like peptide-1 receptor agonist treatment without insulin. In women with T1D or T2D, respectively, during early pregnancy, 59% and 62% had HbA1c <7.0% (53 mmol/mol); 16% and 36% reported not taking folic acid before or during early pregnancy. Overall, >40% of women had ≥1 chronic concomitant condition (predominantly thyroid disease or hypertension). Retinopathy was the most commonly reported diabetic complication. The most commonly reported previous pregnancy complication was miscarriage. Conclusions: Baseline data from this large multinational population of women with pre-existing diabetes indicate that sub-optimal glycemic control, poor pregnancy planning, and chronic concomitant conditions were common in early pregnancy.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Journal of Maternal-Fetal and Neonatal Medicine |
| Vol/bind | 35 |
| Udgave nummer | 25 |
| Sider (fra-til) | 7992-8000 |
| Antal sider | 9 |
| ISSN | 1476-7058 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
The authors thank all investigators, trial staff, and participants of this study. Medical writing and editorial assistance were provided by Samuel Bestall, Steven Barberini, Jane Blackburn, Erin Slobodian, and Helen Marshall of Ashfield MedComms, an Ashfield Health company, funded by Novo Nordisk A/S. We would also like to thank Balamurali Kalyanam and Pranav Kelkar, of Novo Nordisk, for review of and input to the manuscript.
Funding Information:
EM has received speakers' fees from Novo Nordisk, Lilly, and Sanofi Aventis; and has participated in steering committee tasks and guidance involving writing protocols for Novo Nordisk. KC has received speaker honoraria from or has participated in advisory boards for Novo Nordisk, Lilly, Sanofi, AstraZeneca, Boehringer Ingelheim, and Servier. JMD has received speaker honoraria from or has participated in advisory boards for Novo Nordisk, Lilly, Sanofi, Amgen, Abbott, AstraZeneca, Boehringer Ingelheim, Mundipharma, and MSD. ME and LLNH are employees of, and hold shares in, Novo Nordisk. RKN is an employee of Novo Nordisk. SDG is a consultant for Sanofi-Aventis, Eli Lilly and Co., Novo Nordisk, Takeda, MSD, Servier, and Theracos. HH has received lecturer and scientific advisor fees from Abbott, Eli Lilly, Lifescan, and Novo Nordisk; and research grants from Abbott, Lifescan, and Novo Nordisk. HPK has received speaker honoraria from, or has participated in advisory boards for, Novo Nordisk, Lilly, Sanofi-Aventis, AstraZeneca, and Servier. DRM has received speaker honoraria from, or has participated in advisory boards for, Novo Nordisk. NA, EA, HWdV, FD, and MI have no conflicts of interest to declare.
Publisher Copyright:
© 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
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