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Detemir insulin, being used increasingly during pregnancy, may have pharmacological benefit compared to neutral protamine Hagedorn (NPH).We evaluated the probability that treatment with detemir compared to NPH reduces the risk for adverse neonatal outcome among individuals with Type 2 diabetes mellitus (T2DM) or early gestational diabetes (GDM; diagnosed <21 weeks).
We performed a multicenter randomized controlled trial from 09/2018 to 01/2020, which included singleton gestation and T2DM or early GDM who sought obstetrical care ≤21 weeks. Participants were allocated to receive either Detemir or NPH by a center-stratified scheme. Primary outcome was a composite of adverse neonatal outcomes (shoulder dystocia, large for gestational age, neonatal intensive care unit admission, respiratory distress, or hypoglycemia). We utilized Bayesian statistics to estimate a sample size of 108 to have >75% probability of any reduction in the primary outcome, assuming 80% power and a hypothesized effect of 33% reduction with detemir. All analyses were intent to treat under a Bayesian framework with neutral priors (a prior assumed a 50-50 likelihood of either intervention being better (NCT 03620890).
We met our planned sample size. Groups were similar at baseline (Table 1). Five participants had pregnancy loss prior to 24 weeks. Table 2 described neonatal and maternal outcomes. Bayesian analysis indicates an 87% posterior probability of reduced primary outcome with detemir relative to NPH (posterior adjusted relative risk, 0.88, 95% credible interval, 0.61 – 1.11). Bayesian analyses were also performed for secondary outcomes with consistent findings of lower adverse outcomes with use of detemir vs NPH such as maternal hypoglycemic events (97% probability of benefit), and hypertensive disorders (85% probability of benefit).
In our comparative effectiveness trial, use of detemir compared to NPH resulted in lower rates of adverse neonatal outcomes, driven by improvement in respiratory outcomes and NICU admission.