Phenotypic and Genotypic Characterization of New-onset Type I Diabetes

What Was Tested

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

The goal of DIATAG study is the identification of biomarkers of T1D evolution in a pediatric cohort.

It had 1 arm (groups): New-onset Type 1 diabetes (experimental).

The registry classes the interventions as other.

More on the Plan

Type 1 diabetes (T1D) is a common chronic disease in childhood.

Clinical presentation at onset of T1D can vary among patients from long-standing diabetes triad symptoms (polyuria, polydipsia and weight loss) to coma and ketoacidosis.

The investigators initiated a collaborative consortium including six pediatric clinics in Belgium to better characterize new-onset T1D patients.

Different subgroups of T1D patients might exist, underlying different physiopathology of T1D : * The investigators will first investigate the presence of biomarkers in different fluids (e.g. urine, blood, feces,...). * The investigators will correlate results with clinical parameters of glycemic control.

Who Took Part

Enrollment: 98 actual participants took part.

It was open to people of any sex aged from 6 months up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Polyuria, polydipsia, weight loss ± ketoacidosis. Presence in the serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8). Age between 6 months and 18 years. Male or female. Free written and oral consent.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: children under 6 months of age; treatment that interferes with insulin secretion and insulin sensitivity (e. g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins); presence of celiac disease (diagnosis based on pathological duodenal biopsy), recently diagnosed (within 1 month), at the time of inclusion.

How the Study Was Run

Design: single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-06-15 with completion listed for 2022-08-15.

It ran at 1 site in Belgium.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Evaluation of T1D subgroups by using follow-up of clinical parameters : weight in kilograms (time frame: up to 18 months after diagnosis). Evaluation of T1D subgroups by using follow-up of clinical parameters : Height in centimeter (time frame: up to 18 months after diagnosis). Evaluation of T1D subgroups by using follow-up of clinical parameters : Body mass index (kg/m²) (time frame: up to 18 months after diagnosis).

It also tracked 1 secondary outcome, for example Production of prediction model of β-cell mass evolution.

What This Means in Plain Language

Put simply, this is a not phased trial of Glucagon in 98 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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