Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial

What Was Tested

Researchers studied Insulin Detemir and NPH Insulin (isophane) in this randomized controlled trial publication.

Who Took Part

By PubMed's age tags, the people studied were adults, women only.

The researchers performed a multiclinic randomized controlled trial (September 2018 to January 2020), which included women with singleton gestation with type 2 or overt type 2 diabetes mellitus who sought obstetrical care at ≤21 weeks' gestation.

Participants were randomized to receive either insulin detemir or neutral protamine Hagedorn by a clinic-stratified scheme.

How the Study Was Run

In design terms this was a randomized study.

Random assignment meant chance, not the researchers, decided who got Insulin Detemir and who got the comparison, which limits bias.

The primary outcome was a composite of adverse neonatal outcomes, including shoulder dystocia, large for gestational age, neonatal intensive care unit admission, respiratory distress (defined as the need of at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life), or hypoglycemia.

The secondary neonatal outcomes included gestational age at delivery, small for gestational age, 5-minute Apgar score of <7, lowest glucose level, need for intravenous glucose, respiratory distress syndrome, need for mechanical ventilation or continuous positive airway pressure, neonatal jaundice requiring therapy, brachial plexus injury, and hospital length of stay.

The secondary maternal outcomes included hypoglycemic events, hospital admission for glucose control, hypertensive disorder of pregnancy, maternal weight gain, cesarean delivery, and postpartum complications.

All analyses were intent to treat under a Bayesian framework with neutral priors (a priori assumed a 50:50 likelihood of either intervention being better; National Clinical Trial identifier 03620890).

What Was Measured

PubMed files the paper under topics including Abortion, Spontaneous, Diabetes Mellitus, Type 2, Fetal Macrosomia, Gestational Age, Hypoglycemia, Insulin Detemir and Insulin, Isophane.

Author keywords: hypertensive disorder of pregnancy, large for gestational age, maternal adverse outcomes, maternal hypoglycemia, neonatal adverse outcomes and neonatal hypoglycemia.

What This Means in Plain Language

The paper is a randomized study of Insulin Detemir and NPH Insulin (isophane).

Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2021 (American journal of obstetrics and gynecology), a journal based in United States.

More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page.