Severe HypoglycemiaGLUREDIANCT06770621
Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes
A study testing Insulin-induced hypoglycemia test, Glucagon profile and Biological sample once in people with Severe Hypoglycemia and Type1diabetes, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Hypoglycemia, Type1diabetes
- What is being tested?
- Insulin-induced hypoglycemia test, Glucagon profile and Biological sample once
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- 25 May 2022to 25 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
- Obesity defined as a BMI with a z-score >+3 SD.
- Hepatic, renal or adrenal insufficiency.
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- History of bone marrow transplantation.
- History of diabetes after hemolytic-uremic syndrome.
- Epileptic patient
- Absence of anti-islet autoantibodies.
- Dysmorphia with suspicion of underlying genetic syndrome.
- Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.
- WP2 :
- Child under 2 years of age.
- Taking treatments that interfere 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.
- Obesity defined as a BMI with a z-score >+3 SD.
- Hepatic, renal or adrenal insufficiency.
- History of bone marrow transplantation.
- History of diabetes after hemolytic-uremic syndrome.
- Absence of anti-islet autoantibodies.
- Dysmorphia with suspected underlying genetic syndrome.
- Participation in another study within the previous 3 months with administration of blood derivatives or potentially immunomodulatory treatments.
- WP3 :
- Taking treatments that interfere 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.
- Obesity defined as a BMI with a z-score >+3 SD.
- Hepatic, renal or adrenal insufficiency.
- History of bone marrow transplantation.
- History of diabetes after hemolytic-uremic syndrome.
- Ischemic cardiomyopathy
- Pregnant participant
- Epileptic patient
- WP4 :
- Child under 2 years of age.
- Body weight less than 17 kg.
- Taking treatments that interfere 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.
- Obesity defined as a BMI with a z-score >+3 SD.
- Hepatic, renal or adrenal insufficiency.
- History of bone marrow transplantation.
- History of diabetes after hemolytic-uremic syndrome.
- Dysmorphia with suspected underlying genetic syndrome.
- Participation in another study within the last 3 months, with administration of blood derivatives or potentially immunomodulatory treatments.
- WP5 :
- Child under 2 years of age.
- Body weight less than 17 kg.
- Taking treatments that interfere 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.
- Obesity defined as a BMI with a z-score >+3 SD..
- History of bone marrow transplantation.
- History of diabetes after hemolytic-uremic syndrome.
- Participation in another study within the last 3 months, with administration of blood derivatives or potentially immunomodulatory treatments.
- WP6 :
- Child under 2 years of age.
- Taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
- Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
- Obesity defined as a BMI with a z-score >+3 SD.
- Hepatic, renal or adrenal insufficiency.
- History of bone marrow transplantation.
- History of diabetes after hemolytic-uremic syndrome.
- Epileptic patient
- Dysmorphia with suspicion of underlying genetic syndrome.
- Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.
- WP7 :
- 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.
- Obesity defined as a BMI with a z-score >+3 SD.
- Hepatic, renal or adrenal insufficiency.
- History of bone marrow transplantation.
- History of diabetes after hemolytic-uremic syndrome.
- Epileptic patient
- Absence of anti-islet autoantibodies.
- Dysmorphia with suspicion of underlying genetic syndrome.
- Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Clinique Universitaires Saint Luc
Brussels, Woluwe-saint-lambert, 1200
Philippe Lysy, Pr, 027641370 ext. +32, philippe.lysy@saintluc.uclouvain.be
About this study
Official title: 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.
- Conditions
- Severe Hypoglycemia, Type1diabetes
- Being tested
- Insulin-induced hypoglycemia test, Glucagon profile, Biological sample once, Observation-questionnaire
- Keywords
- Pediatric, Hypoglycemia, Diabetes
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin-induced hypoglycemia testDiagnostic 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.
Glucagon profileDiagnostic test
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)
Biological sample onceOther
The exome of each patient will then be analyzed from the blood sample taken beforehand.
Observation-questionnaireOther
only the answer to a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| To investigate the evolution of pancreatic α-cell function. (WP1) | Experimental | Regular clinical and biological monitoring will be conducted during this period, as well as four insulin-induced hypoglycemia (IIH) tests. Hormones and other blood parameters will be measured, and an analysis of the genome, proteome, and micro-RNAs (miRs) will be performed during these IIH tests and throughout the biological monitoring. The primary goal of this study is to find a correlation between the patient's phenotype and the various biological results obtained, mainly blood biomarkers, in order to subsequently determine models to predict the state of pancreatic α-cell function in the first months post-diagnosis. Receives: Diagnostic Test: Insulin-induced hypoglycemia test |
| Conduct an assessment of the management of severe hypoglycemia. (WP2) | 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. Receives: Other: Observation-questionnaire |
| Evaluate the α-cell function in first-degree relatives of patients with type 1 diabetes. (WP3) | Experimental | In this cohort of relatives, the investigators will evaluate the function of pancreatic α-islets and the counter-regulation mechanism. This evaluation will have two main objectives. The first objective will be to compare this counter-regulation mechanism between individuals without type 1 diabetes and patients with type 1 diabetes. The second objective is to determine whether the dysfunction of the counter-regulation mechanism in diabetic patients is solely due to type 1 diabetes or if there is a familial component to this dysfunction. Receives: Diagnostic Test: Insulin-induced hypoglycemia test |
| Characterize the glycemic profile and α-cell function. (WP4) | Experimental | The aim is to assess residual function in patients with pancreatic disease, the phenomenon of counter-regulation and its impact on carbohydrate metabolism. To this end, IIH tests will be carried out in these patients, during which blood samples will be taken as in patients with type 1 diabetes (see above). This group of patients will also serve as a control group for the study of our diabetic patients.
Patient with : exocrine dysfunction of the pancreas either as a consequence of cystic fibrosis or as a consequence of (sub)total pancreatectomy. Receives: Diagnostic Test: Insulin-induced hypoglycemia test |
| Evaluate the phenomenon of counter-regulation in patients with proven growth hormone. (WP5) | Active comparator | These patients will serve as control groups for our GLUREDIA study to assess counter-regulation in our diabetic patients.
Patient with : groth hormone or adrenal hormone deficiency and in healthy patients with no proven hormone deficiency. Receives: Diagnostic Test: Insulin-induced hypoglycemia test |
| Study the link between the clinical characteristics of diabetic patients and their genome (WP6) | Experimental | For each participant, the investigators will study their clinical history and the evolution of their glycemic parameters from diagnosis to the date they agreed to take part in the study (retrospective analysis). Next, each patient's exome will be analyzed from a blood tube taken during a consultation following agreement to take part in the study. With these analyses, the investigators hope to gain a better understanding of the clinical course of our diabetic patients and their risk of severe hypoglycemia. Receives: Other: Biological sample once |
| Evaluation of the circadian rhythm of glucagon (WP7) | Experimental | After recruitment, each participant will complete a questionnaire assessing their sensitivity to hypoglycemia. Based on their responses and phenotype, participants will be divided into two cohorts for analysis. Subsequently, a glucagon profile will be established for each participant through quarterly consultations involving blood samples taken by a pediatric nurse. Receives: Diagnostic Test: Glucagon profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the evolution of pancreatic α-cell function. (WP1)
Regular clinical and biological monitoring will be performed during this period as well as four insulin-induced hypoglycemia (IIH) tests.
Measured: 18 months per patient
To evaluate the presence of blood biomarkers that correlate with the evolution of α-cell function. (WP1)
Regular clinical and biological monitoring will be performed during this period as well as four insulin-induced hypoglycemia (IIH) tests. Hormones and other blood parameters will be measured and genome, proteome and microRNA (miRs) analysis will be performed during the IIH tests and during the biological follow-up. The expected results are the description and prediction of CRR in the first months after T1DM.
Measured: 18 months per patient
Secondary outcomes (6)
Conduct an assessment of the management of severe hypoglycemia. (WP2)
Use of a questionnaire which is sent out once per patient during a routine consultation. The analysis does not take the form of a score, but is based on the analysis of the answers to the question according to the patient's profile. (WP2)
Measured: Baseline
Evaluate the α-cell function in first-degree relatives of patients with type 1 diabetes. (WP3)
In the remaining parents, those without biological signs of (pre-)diabetes, an IIH test will be performed during which blood samples identical to those performed in patients with type 1 diabetes will be taken. (WP3)
Measured: Baseline
Characterize the glycemic profile and α-cell function. (WP4)
IIH tests will be performed in these patients during which blood samples will be taken as in patients with type 1 diabetes. This group of patients will also be a control group for the study of our diabetic patients. (WP4)
Measured: Baseline
Evaluate the phenomenon of counter-regulation in patients with proven growth hormone. (WP5)
Patients suspected of adrenal or pituitary hormone deficiency, will perform as part of their diagnosis a hypoglycemic test. Here the difference is that the investigators will add two additional tubes to each sample, to those already collected as part of the hypoglycemic test. These tubes will be used, as in the other parts, to measure hormones and other blood parameters, as well as to perform an analysis of the genome, proteome and micro-RNAs (miRs).
(WP5)
Measured: Baseline
Study the link between the clinical characteristics of diabetic patients and their genome (WP6)
For each participant, the investigators will study their clinical history, the evolution of their glycemic parameters from diagnosis to the date they agree to take part in the study (retrospective analysis). Next, each patient's exome will be analyzed from a blood tube taken during a consultation following agreement to take part in the study. With these analyses, the inestigators hope to gain a better understanding of the clinical course of our diabetic patients and their risk of severe hypoglycemia. (WP6)
Measured: Baseline
Evaluation of the circadian rhythm of glucagon (WP7)
Each participant will complete a questionnaire assessing his or her susceptibility to hypoglycemia. A glucagonemic profile will then be established for each participant. This step, carried out during quarterly consultations, will involve blood sampling. (WP7)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start25 May 2022
- Primary completion25 Oct 2025 (estimated)
- Study completion25 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study, parallel Assignment, the main objective is diagnostic, open-label, this study has 7 sub-sections.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor
- Investigators
- Philippe Lysy, Pr, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770621
- Sponsor's protocol ID
- 2022/02FEV/043
- Acronym
- GLUREDIA
- Status last verified
- Jan 2025
- First submitted
- 25 Jul 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harvengt A, Beckers M, Iakovidou I, Maure A, Syed Z, Boutsen L, Beckers D, Lysy PA. Early loss and progressive deterioration of glucagon responses to hypoglycemia in children with type 1 diabetes. BMJ Open Diabetes Res Care. 2026 Aug 26;14(4):e005959. doi: 10.1136/bmjdrc-2026-005959.
PubMed 42648789
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes (GLUREDIA Study): Characteristics and Predictive Biomarkers.
- ClinicalTrials.gov ID
- NCT06770621
- Acronym / sponsor ID
- GLUREDIA / 2022/02FEV/043
- Conditions
- Severe Hypoglycemia, Type1diabetes
- Keywords
- Pediatric, Hypoglycemia, Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 25 May 2022 (actual)
- Primary completion
- 25 Oct 2025 (estimated)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Interventional study, parallel Assignment, the main objective is diagnostic, open-label, this study has 7 sub-sections.
| Arm | Type | Receives |
|---|---|---|
| To investigate the evolution of pancreatic α-cell function. (WP1) | Experimental | Diagnostic Test: Insulin-induced hypoglycemia testRegular clinical and biological monitoring will be conducted during this period, as well as four insulin-induced hypoglycemia (IIH) tests. Hormones and other blood parameters will be measured, and an analysis of the genome, proteome, and micro-RNAs (miRs) will be performed during these IIH tests and throughout the biological monitoring. The primary goal of this study is to find a correlation between the patient's phenotype and the various biological results obtained, mainly blood biomarkers, in order to subsequently determine models to predict the state of pancreatic α-cell function in the first months post-diagnosis. |
| Conduct an assessment of the management of severe hypoglycemia. (WP2) | Active comparator | Other: Observation-questionnaireStudy 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. |
| Evaluate the α-cell function in first-degree relatives of patients with type 1 diabetes. (WP3) | Experimental | Diagnostic Test: Insulin-induced hypoglycemia testIn this cohort of relatives, the investigators will evaluate the function of pancreatic α-islets and the counter-regulation mechanism. This evaluation will have two main objectives. The first objective will be to compare this counter-regulation mechanism between individuals without type 1 diabetes and patients with type 1 diabetes. The second objective is to determine whether the dysfunction of the counter-regulation mechanism in diabetic patients is solely due to type 1 diabetes or if there is a familial component to this dysfunction. |
| Characterize the glycemic profile and α-cell function. (WP4) | Experimental | Diagnostic Test: Insulin-induced hypoglycemia testThe aim is to assess residual function in patients with pancreatic disease, the phenomenon of counter-regulation and its impact on carbohydrate metabolism. To this end, IIH tests will be carried out in these patients, during which blood samples will be taken as in patients with type 1 diabetes (see above). This group of patients will also serve as a control group for the study of our diabetic patients. Patient with : exocrine dysfunction of the pancreas either as a consequence of cystic fibrosis or as a consequence of (sub)total pancreatectomy. |
| Evaluate the phenomenon of counter-regulation in patients with proven growth hormone. (WP5) | Active comparator | Diagnostic Test: Insulin-induced hypoglycemia testThese patients will serve as control groups for our GLUREDIA study to assess counter-regulation in our diabetic patients. Patient with : groth hormone or adrenal hormone deficiency and in healthy patients with no proven hormone deficiency. |
| Study the link between the clinical characteristics of diabetic patients and their genome (WP6) | Experimental | Other: Biological sample onceFor each participant, the investigators will study their clinical history and the evolution of their glycemic parameters from diagnosis to the date they agreed to take part in the study (retrospective analysis). Next, each patient's exome will be analyzed from a blood tube taken during a consultation following agreement to take part in the study. With these analyses, the investigators hope to gain a better understanding of the clinical course of our diabetic patients and their risk of severe hypoglycemia. |
| Evaluation of the circadian rhythm of glucagon (WP7) | Experimental | Diagnostic Test: Glucagon profileAfter recruitment, each participant will complete a questionnaire assessing their sensitivity to hypoglycemia. Based on their responses and phenotype, participants will be divided into two cohorts for analysis. Subsequently, a glucagon profile will be established for each participant through quarterly consultations involving blood samples taken by a pediatric nurse. |
Who may qualify
- Ages
- 2 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (51 listed)
- 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.
Key exclusion criteria (81 listed)
- 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.
- Obesity defined as a BMI with a z-score >+3 SD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin-induced hypoglycemia testFor 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 | Characterize the glycemic profile and α-cell function. (WP4), Evaluate the phenomenon of counter-regulation in patients with proven growth hormone. (WP5), Evaluate the α-cell function in first-degree relatives of patients with type 1 diabetes. (WP3), To investigate the evolution of pancreatic α-cell function. (WP1) |
| Glucagon profileThe 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) | Diagnostic test | Evaluation of the circadian rhythm of glucagon (WP7) |
| Biological sample onceThe exome of each patient will then be analyzed from the blood sample taken beforehand. | Other | Study the link between the clinical characteristics of diabetic patients and their genome (WP6) |
| Observation-questionnaireonly the answer to a questionnaire | Other | Conduct an assessment of the management of severe hypoglycemia. (WP2) |
Primary outcome
To investigate the evolution of pancreatic α-cell function. (WP1)
Time frame: 18 months per patient
Regular clinical and biological monitoring will be performed during this period as well as four insulin-induced hypoglycemia (IIH) tests.
To evaluate the presence of blood biomarkers that correlate with the evolution of α-cell function. (WP1)
Time frame: 18 months per patient
Regular clinical and biological monitoring will be performed during this period as well as four insulin-induced hypoglycemia (IIH) tests. Hormones and other blood parameters will be measured and genome, proteome and microRNA (miRs) analysis will be performed during the IIH tests and during the biological follow-up. The expected results are the description and prediction of CRR in the first months after T1DM.
6 secondary outcomes
Conduct an assessment of the management of severe hypoglycemia. (WP2)
Time frame: Baseline
Evaluate the α-cell function in first-degree relatives of patients with type 1 diabetes. (WP3)
Time frame: Baseline
Characterize the glycemic profile and α-cell function. (WP4)
Time frame: Baseline
Evaluate the phenomenon of counter-regulation in patients with proven growth hormone. (WP5)
Time frame: Baseline
Study the link between the clinical characteristics of diabetic patients and their genome (WP6)
Time frame: Baseline
Evaluation of the circadian rhythm of glucagon (WP7)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Derived from this study: PubMed 42648789Harvengt A, Beckers M, Iakovidou I, Maure A, Syed Z, Boutsen L, Beckers D, Lysy PA. Early loss and progressive deterioration of glucagon responses to hypoglycemia in children with type 1 diabetes. BMJ Open Diabetes Res Care. 2026 Aug 26;14(4):e005959. doi: 10.1136/bmjdrc-2026-005959.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe Lysy, Pr principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin-induced hypoglycemia test, Glucagon profile and Biological sample once in people with Severe Hypoglycemia and Type1diabetes, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 51 inclusion and 81 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Lysy, Pr (027641370 ext. +32, antoine.harvengt@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the evolution of pancreatic α-cell function. (WP1) (time frame: 18 months per patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.