Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial

What Was Tested

This registered phase 4 trial tested Insulin Aspart.

Active treatment group will receive insulin-glucose-infusion during labour.

In the observational group, blood glucose level during labour will be monitored and insulin-glucose-infusion is started only if needed.

It had two arms (groups): Insulin-glucose-infusion (experimental) and Observation (active comparator).

Insulin-glucose-infusion is administered once active labour begins and will be continued until birth.

The registry classes the interventions as drug.

More on the Plan

Intrapartum blood glucose level has negative correlation to neonatal blood glucose level in type 1 diabetics.

In gestational diabetes the correlation is less clear.

In the view of current knowledge, it seems that moderately elevated intrapartum blood glucose may not cause neonatal hypoglycemia.

There is no consensus of how to treat intrapartum blood glucose level in gestational diabetics.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to women only.

Healthy volunteers could join, not only people with the condition.

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: planned caesarean section,; premature birth (\< 37 gestational weeks).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

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.

It started in 2015-09 with completion listed for 2020-12.

It ran at 1 site in Finland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Neonatal hypoglycemia (time frame: within 48 hours after birth).

It also tracked 4 secondary outcomes, for example Moderate neonatal hypoglycemia, Severe neonatal hypoglycemia, Duration of neonatal blood glucose monitoring and Proportion of participants needing insulin-glucose-infusion in the observational arm.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Aspart in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.