NCT06770621

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

Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes (GLUREDIA Study): Characteristics and Predictive Biomarkers.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 2 Years – 30 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Severe Hypoglycemia
• Type1diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Insulin-induced hypoglycemia test	For these tests, multiple blood samples will be collected during insulin-induced hypoglycemia (stage 1 hypoglycemia is defined as a blood glucose level below 70 mg/dL, while stage 2 corresponds to values below 54 mg/dL). The tests will be conducted on patients who have fasted for at least 12 hours and will be supervised by a medical staff member trained to manage severe hypoglycemia.
DIAGNOSTIC_TEST	Glucagon profile	The subject must fast before the consultation and follow a specific diet the day before; after an initial blood draw (P1), the patient will have breakfast and take any required insulin, followed by two additional blood draws 1.5 hours after breakfast (P2) and 1.5 hours after P2 (P3)
OTHER	Biological sample once	The exome of each patient will then be analyzed from the blood sample taken beforehand.
OTHER	Observation-questionnaire	only the answer to a questionnaire

Timeline

• Start date: 2022-05-25
• Primary completion: 2025-10-25
• Completion: 2025-10-25
• First posted: 2025-01-13
• Last updated: 2025-01-13

Locations

1 site across 1 country: Belgium