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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-30
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

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. Despite several studies in adults, the presence of CRR dysfunction remains unpredictable and not well understood. The objective of GLUREDIA is therefore to describe and predict the evolution of CRR in children with T1DM.

Eligibility criteria

Qualifiers

De novo type 1 diabetic patient, as per ISPAD criteria;

Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +/- Acido ketosis.

Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at 120 minutes of an OGTT AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see 8. a. 2.) with random blood glucose ≥200 mg/dL.

Patients aged between 2 and 30 years

Disqualifiers

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.

Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.

Trial design

Treatments tested in this trial

  • Insulin-induced hypoglycemia test
  • Glucagon profile
  • Biological sample once
  • Observation-questionnaire

Treatment groups

1,000 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator