Hôpital Necker-Enfants Malades
Paris, 75015, France
NCT Number: NCT04322435
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.
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Notify Me6 month–6 year
All sexes
Interventional
Not applicable
Paris, 75015, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.
Measurement of capillary blood glucose :
Time frame: 1 year
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).
Time frame: 1 year
Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.
Time frame: 1 year
Percentage of time in hypoglycaemia during the continuous blood glucose measurements.
Time frame: 1 year
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.
Time frame: 1 year
Circumstances in which hypoglycaemia occurred : descriptive data by parents, symptomatic or not symptomatic hypoglycaemia, descriptive signs if they are presents.
Time frame: 1 year
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).
Time frame: 1 year
Body mass divided by the square of the body height expressed in units of kg/m2 : mass in kilograms and height in meters
Time frame: 1 year
Expressed millimetre of mercury
Time frame: 1 year
Number of beats per minute
Time frame: 1 year
stade tanner A1 to A5
Time frame: 1 year
Number of grams per day
Time frame: 1 year
microgram / deciliter
Time frame: 1 year
Nanomole per liter
Time frame: 1 year
Nanogram per liter
Time frame: 1 year
Nanomole per liter
Time frame: 1 year
Nanomole per liter
Time frame: 1 year
Nanomole per liter
Time frame: 1 year
Nanomole per liter
Time frame: 1 year
picogram/milliliter
Assistance Publique - Hôpitaux de Paris
Other
Acronym: GLYSUR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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