Dasiglucagon in Children With Congenital Hyperinsulinism Up to 1 Year of Age: Results From a Randomized Clinical Trial

What Was Tested

Researchers studied Glucagon in this randomized controlled trial publication.

Congenital hyperinsulinism (CHI) is a cause of persistent hypoglycemia in childhood with a considerable risk of lifelong neurological sequelae.

Dasiglucagon is a glucagon analog for the treatment of hypoglycemia.

Who Took Part

The abstract describes 1, participants taking part.

By PubMed's age tags, the people studied were infants, both men and women.

Participants comprised children with CHI aged 7 days to 12 months who were dependent on IV glucose.

In part 1, participants were randomized to dasiglucagon or placebo for 48 hours, then crossed over to the other treatment for 48 hours.

How the Study Was Run

In design terms this was a randomized, double-blind, open-label, placebo-controlled and crossover study.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Glucagon, so expectations could not easily colour the readings.

Being open-label, the Glucagon study did not mask who received what.

Some participants received a placebo instead of Glucagon, giving a reference point.

A time span of 21 days appears in the methods.

This study included a randomized, crossover, double-blind, placebo-controlled part 1 and an open-label, single-arm part 2 at 4 centers in Germany, the United Kingdom, and the United States.

In part 2, all participants received dasiglucagon for 21 days.

The primary outcome was mean IV glucose infusion rate (GIR) in the last 12 hours of part 1.

What Was Measured

Topics PubMed links to this paper include Congenital Hyperinsulinism, Glucagon, Blood Glucose, Prognosis and Hypoglycemia.

Author keywords: dasiglucagon and treatment.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Glucagon in 1, participants over 21 days.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2025 (The Journal of clinical endocrinology and metabolism), a journal based in United States.

More context: the Glucagon compound page, all human trials.