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| ID | Type | Description | Link |
|---|---|---|---|
| ID RCB 2019-A02250-57 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is probably underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely.
The objective of the study is to evaluate the prevalence of hypoglycaemia in children with adrenal insufficiency.
Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely.
The objective of the study is to evaluate the prevalence of hypoglycaemia in children with congenital adrenal insufficiency.
The study will follow for one year children from 6 months to 6 years, with central and peripheral adrenal insufficiency.
4 study times are planned with two measurement methods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrenal insufficiency | Other | Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous blood glucose measurement | Other | Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of hypoglycaemia | Number of hypoglycaemic events. Hypoglycaemia will be defined by a glucose level measured at a glucose level of less than or equal to 0.55 g /L (3 mmol /L). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hypoglycaemia | Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements. | 1 year |
| Percentage of time in hypoglycaemia | Percentage of time in hypoglycaemia during the continuous blood glucose measurements. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dinane Samara-Boustani, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Michel Polak, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker-Enfants Malades | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37952170 | Result | Galderisi A, Kariyawasam D, Stoupa A, Quoc AN, Pinto G, Viaud M, Brabant S, Beltrand J, Polak M, Samara-Boustani D. Glucose pattern in children with classical congenital adrenal hyperplasia: evidence from continuous glucose monitoring. Eur J Endocrinol. 2023 Nov 8;189(5):K19-K24. doi: 10.1093/ejendo/lvad147. |
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| ID | Term |
|---|---|
| C566130 | Adrenal Insufficiency, Congenital |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Measurement of capillary blood glucose | Other | Measurement of capillary blood glucose :
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| 1 year |
| Glycemic variations rate | Glycemic variations rate during the different measurements times: minimum rate, maximum rate, average, median. Each result will be expressed in g /L or in mmol /L. Each date will expressed by one day and for one week. | 1 year |
| Circumstances of occurrence of hypoglycaemia | Circumstances in which hypoglycaemia occurred : descriptive data by parents, symptomatic or not symptomatic hypoglycaemia, descriptive signs if they are presents. | 1 year |
| Occurrence of medical events | Events during the follow-up of the study: modification of treatment of hydrocortisone and fludrocortisone, re-sugaring expressed in number of sugar cubes ( by sugar cube = 20 gr of sugar) or type of sweet food given to the child, hospitalizations ( type and reason for hospitalization, cause of the decompensation). | 1 year |
| Body Mass Index | Body mass divided by the square of the body height expressed in units of kg/m2 : mass in kilograms and height in meters | 1 year |
| Systolic and Diastolic Blood Pressure | Expressed millimetre of mercury | 1 year |
| Heart rate | Number of beats per minute | 1 year |
| Stade tanner | stade tanner A1 to A5 | 1 year |
| Amount of salt consumed per day | Number of grams per day | 1 year |
| Cortisol at 8 a.m. | microgram / deciliter | 1 year |
| Cycle of 17-hydroxyprogesterone | Nanomole per liter | 1 year |
| Adreno CorticoTropic Hormone | Nanogram per liter | 1 year |
| 17-hydroxyprogesterone | Nanomole per liter | 1 year |
| Delta-4-Androstenedione | Nanomole per liter | 1 year |
| Testosterone | Nanomole per liter | 1 year |
| Ionogram | Nanomole per liter | 1 year |
| Renin | picogram/milliliter | 1 year |