Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes (GLUREDIA Study): Characteristics and Predictive Biomarkers.
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.
‣ 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.
∙ Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
• Patients aged between 2 and 30 years
• Minimum weight: 17 kg (for blood samples)
• Male - female patients
• Free, written and oral consent.
‣ 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.
⁃ Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
⁃ Patients aged between 2 years and 18 years (\<18 years).
⁃ Male - female patients
⁃ Free, written and oral consent.
‣ Adult older than 18 years.
⁃ Absence of blood marker of diabetes (Absence of antibodies, HbA1C \<6.5%, C-peptide \> 0.18 nmol/L, Fasting blood glucose \< 100 mg/dL, blood glucose at any time \< 200 mg/dL).
⁃ Be a first-degree relative with a patient being followed for diabetes (meeting ISPAD criteria).
⁃ Male - Female
⁃ Free written and oral consent
∙ Cohort of patients followed for cystic fibrosis:
• Pediatric patient between 2 and 18 years of age.
• Diagnosed with cystic fibrosis with impaired pancreatic endocrine function.
• Presents glucose homeostasis disorders (regular hypo/hyper-glycemia).
• Male - female patient
• Free, written and oral consent
∙ Cohort of patients with (sub)total pancreatectomy:
• Pediatric patients between 2 and 18 years of age.
• Follow-up for total pancreatectomy or caudal pancreatectomy
• Presents disorders of carbohydrate homeostasis (regular hypo-/hyper-glycemia)
• Male - female patient
• Free, written and oral consent
‣ Patient who has undergone insulin testing due to suspected growth hormone deficiency or adrenal insufficiency or hypopituitarism.
⁃ Patients between the ages of 2 years and 18 years (\<18 years).
⁃ Male - female patient.
⁃ Free written and oral consent.
‣ 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.
⁃ Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
⁃ Patients aged between 2 and 18 years (\<18 years).
⁃ Male - female patients
⁃ Free, written and oral consent.
‣ 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.
⁃ Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
⁃ Patients aged between 2 and 18 years
⁃ Minimum weight: 17 kg (for blood samples)
⁃ Male - female patients
⁃ Free, written and oral consent.