American Journal of Obstetrics and Gynecology
SMFM paperRandomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes
Section snippets
Materials and Methods
This open-label, noninferiority, randomized study was conducted between March 2013 and January 2015. The study was approved by the institutional review board (#12-166) of Mount Sinai Roosevelt Hospital and was registered in ClinicalTrials.gov (NCT01837680). Eligible subjects were all pregnant women with a viable singleton or twin gestation, with either preexisting T2DM or GDM at ≤34 weeks, in need of medical therapy, who received care at our institution. GDM was diagnosed based on a positive
Results
During the study period of March 2013 through October 2014, 740 women entered the DIPP. In all, 635 women were excluded, leaving 105 women consented for randomization (53 to the NPH group, and 52 to the detemir group). In the detemir group, 46 patients received the allocation for the duration of treatment and 6 patients did not as they had an allergic reaction. Two patients were lost to follow-up, and 2 discontinued the detemir due to personal preference and switched to an oral hypoglycemic
Comment
From our data, we conclude that IDet is noninferior to insulin NPH for the treatment of GDM and T2DM in pregnancy. We have demonstrated this by using multiple analyses to validate and corroborate our results. First, by using a mixed effects model to analyze the primary outcome, we were able to account for the fact that patients came to follow-up visits at variable time intervals and therefore we may have overrepresentation of glucose data obtained over short intervals. Secondly, we have
Acknowledgments
We thank Sophia Scarpelli, RN, CDE, and Debi Lee, RN, CDE, of Roosevelt Hospital Diabetes in Pregnancy Program, Member of Mount Sinai Health System. They have no disclosures of financial funding.
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Cited by (0)
The authors report no conflict of interest.
Cite this article as: Herrera KM, Rosenn BM, Foroutan J, et al. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol 2015;213:426.e1-7.