(853) Randomized Controlled Trial of Detemir versus NPH in Gestational and Type 2 Diabetes: DETERMINE Study

Objective: Diabetes mellitus (DM) is one of the most common complications in pregnancy. Neonatal hypoglycemia (HG) as a result of DM is associated with NICU admissions and delay to milestones. We hypothesized that the longer-acting insulin detemir may yield lower rates of neonatal HG, compared to intermediate-acting NPH in pregnancies with GDM or T2DM.

Study Design: We conducted a prospective, multi-center, unblinded, randomized-controlled trial. Subjects requiring insulin initiation during pregnancy were randomized 1:1 to detemir or NPH. IRB approval and clinicaltrials.gov registration were obtained. Primary outcomes were rates of neonatal HG ( < 45 mg/dl) in the first 24 hours of life, and persistent HG ( < 50 mg/dl) beyond 24 hours. Secondary outcomes were rates of maternal, antenatal and neonatal complications. Data were analyzed using Wilcoxon Rank sum, Chi-Square or Fisher’s exact tests. Uni- and multivariable logistic regressions were performed. Planned enrollment was 336, but the trial was halted early due to discontinuation of detemir in 2024.

Results: 73 subjects were recruited (NPH: 38, Detemir: 35). Demographic differences were not noted for most categories, but intake A1c (NPH: 5.7%, IQR 5.5-6.0%; Det: 6.8%, IQR 6.0-8.7%; p=0.021) and race (more Asian/Caucasian in NPH versus more Black in detemir) differed, likely due to early termination of study. No differences were noted in rates of HG (44.4 v 36.4%, p=0.495) or persistent HG (5.6 v 6.1%, p=1.0), even after controlling for DM type, preterm birth, BMI and site. No differences were noted for secondary neonatal outcomes (Table 2).  Rates of postpartum hemorrhage were higher for NPH (36.8 v 8.8%, p=0.005), but no other differences in maternal outcomes were noted, including mode of delivery, HTN, insulin drip, lacerations, or infection (Table 1).

Conclusion: No difference in rates of neonatal HG were seen between NPH and detemir groups. This study is limited by early termination of the trial due to discontinued production of detemir. Further studies will need to be performed to compare currently available basal insulins in management of DM in pregnancy.