Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women

What Was Tested

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

Who Took Part

The age groups tagged for this paper are adults, women only.

Subjects (n = 322) who were pregnant or planning pregnancy were randomized to IAsp or HI as meal-time insulin in an open-label, parallel-group, multicenter study.

How the Study Was Run

The design is described as randomized, open-label, multicenter and parallel-group.

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

Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Running at several centres spread the Insulin Aspart study over different clinics and patient groups.

The Insulin Aspart group and the comparison group ran side by side rather than switching.

Outcomes assessed included risk of major maternal hypoglycemia, A1C, plasma glucose profiles, and maternal safety outcomes.

What Was Measured

PubMed files the paper under topics including Body Mass Index, Diabetes Mellitus, Type 1, Europe, Gestational Age, Glycated Hemoglobin, Hypoglycemia and Hypoglycemic Agents.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Insulin Aspart and NPH Insulin (isophane).

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2007 (Diabetes care), a journal based in United States.

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