Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes

What Was Tested

In this not phased trial, researchers set out to test Glucagon.

The GLUREDIA study investigates the counter-regulatory response (CRR) during hypoglycemia in children with type 1 diabetes (T1D).

Hypoglycemia can lead to severe symptoms, but is normally counteracted by CRR, corresponding to the secretion of hormones to maintain normoglycemia.

Hypoglycemia is common in T1DM but some patients develop severe hypoglycemia as a result of CRR dysfunction.

It had seven arms (groups): To investigate the evolution of pancreatic α-cell function. (WP1) (experimental), Conduct an assessment of the management of severe hypoglycemia. (WP2) (active comparator), Evaluate the α-cell function in first-degree relatives of patients with type 1 diabetes. (WP3) (experimental), Characterize the glycemic profile and α-cell function. (WP4) (experimental) and Evaluate the phenomenon of counter-regulation in patients with proven growth hormone. (WP5) (active comparator).

Study of glycemic variations collected by the continuous glucose monitoring sensor in the days preceding a severe hypoglycemia. The aim of this analysis is to identify a specific glycemic profile in patients in the days leading up to severe hypoglycemia in order to better anticipate such events.

The registry classes the interventions as diagnostic test and other.

Who Took Part

1000 planned participants were the target.

It was open to people of any sex aged from 2 years up to 30 years.

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

Examples of who could join: Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +/- Acido ketosis. Patients aged between 2 and 30 years. Minimum weight: 17 kg (for blood samples). Male - female patients. Free, written and oral consent.

The full record lists 9 inclusion and 128 exclusion criteria; among the exclusions: child under 2 years of age; taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins); presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

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

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

It started in 2022-05-25 with completion listed for 2025-10-25.

It ran at 1 site in Belgium.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: To investigate the evolution of pancreatic α-cell function. (WP1) (time frame: 18 months per patient). To evaluate the presence of blood biomarkers that correlate with the evolution of α-cell function. (WP1) (time frame: 18 months per patient).

It also tracked 6 secondary outcomes, for example Conduct an assessment of the management of severe hypoglycemia. (WP2), Evaluate the α-cell function in first-degree relatives of patients with type 1 diabetes. (WP3), Characterize the glycemic profile and α-cell function. (WP4), Evaluate the phenomenon of counter-regulation in patients with proven growth hormone. (WP5), Study the link between the clinical characteristics of diabetic patients and their genome (WP6) and Evaluation of the circadian rhythm of glucagon (WP7).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Glucagon in 1000 people.

With 1000 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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