Fetal Overgrowth and Preterm Delivery in Women With Type 1 Diabetes Using Insulin Pumps or Multiple Daily Injections: A Post Hoc Analysis of the EVOLVE Study Cohort

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OBJECTIVETo compare the risk of fetal overgrowth and preterm delivery in pregnant women with type 1 diabetes (T1D) treated with insulin pumps versus multiple daily injections (MDI) and examine whether possible differences were mediated through improved glycemic control or gestational weight gain during pregnancy.RESEARCH DESIGN AND METHODSThe risk of pregnancy and perinatal outcomes were evaluated in a cohort of 2,003 pregnant women with T1D enrolled from 17 countries in a real-world setting during 2013–2018.RESULTSIn total, 723 women were treated with pumps and 1,280 with MDI. At inclusion (median gestational weeks 8.6 [interquartile range 7–10]), pump users had lower mean HbA1c (mean ± SD 50.6 ± 9.8 mmol/mol [6.8 ± 0.9%] vs. 53.6 ± 13.8 mmol/mol [7.1 ± 1.3%], P < 0.001), longer diabetes duration (18.4 ± 7.8 vs. 14.4 ± 8.2 years, P < 0.001), and higher prevalence of retinopathy (35.3% vs. 24.4%, P < 0.001). Proportions of large for gestational age (LGA) offspring and preterm delivery were 59.0% vs. 52.2% (adjusted odds ratio [OR] 1.36 [95% CI 1.09; 1.70], P = 0.007) and 39.6% vs. 32.1% (adjusted OR 1.46 (95% CI 1.17; 1.82), P < 0.001), respectively. The results did not change after adjustment for HbA1c or gestational weight gain.CONCLUSIONSInsulin pump treatment in pregnant women with T1D, prior to the widespread use of continuous glucose monitoring or automated insulin delivery, was associated with a higher risk of LGA offspring and preterm delivery compared with MDI in crude and adjusted analyses. This association did not appear to be mediated by differences in glycemic control as represented by HbA1c or by gestational weight gain.
TidsskriftDiabetes Care
Udgave nummer3
Sider (fra-til)384-392
Antal sider9
StatusUdgivet - 2024

Bibliografisk note

Funding Information:
Acknowledgments. The authors thank all investigators, staff, and participants of this study. Medical writing support was provided by Ryan Ard (Novo Nordisk). A list of all investigators involved in the EVOLVE study cohort are listed in the Supplementary Material. Funding. The Diabetes Pregnancy Registry as part of the EVOLVE study was funded by Novo Nordisk A/S. Duality of Interest. I.H.T. is an industrial PhD student funded by Novo Nordisk and holds shares in Novo Nordisk. L.L.N.H., R.B.N., A.C.A., and M.A.G. are employees of and hold shares in Novo Nordisk. E.R.M. has received speaker fees from Novo Nordisk and has participated in steering committee tasks and guidance involving writing protocols for Novo Nordisk. E.R.M. and P.D. have participated in several multinational clinical studies on the use of insulin in pregnant women with preexisting diabetes in collaboration with Novo Nordisk. No other potential conflicts of interest relevant to this article were reported. Author Contributions. I.H.T drafted the manuscript. I.H.T., L.L.N.H., R.B.N., and J.P. performed the statistical analyses. I.H.T., L.L.N.H., A.C.A., M.-A.G., J.P., P.D., and E.R.M. conceptualized and designed the study. All authors were involved in the interpretation of results, edited the manuscript, and provided input, critical review, and approval of the final version of the manuscript. I.H.T. is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Prior Presentation. Parts of this study were presented in abstract form at the 83rd Scientific Sessions of the American Diabetes Association, San Diego, CA, 23–26 June 2023.

Publisher Copyright:
© 2024 by the American Diabetes Association.

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