Clinical trial NCT04322435: Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
Official title: Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Insufficiency, Congenital
Keywords: Congenital primary and secondary adrenal insufficiency
Cortisol deficiency
Hypoglycaemia
Children
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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:

* Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.
* Measurement of capillary blood glucose, in the morning on an empty stomach, every first week of each month for 12 months, with Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the test strips Accu-Chek performed.
* Measurement of capillary glycaemia in case of suspicion of hypoglycaemia. Measure left free according to the judgment of the parents of the necessary character or not. With Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek performa strips.

Eligibility criteria: Inclusion Criteria:

* All male and female patients, followed in the Paediatric Endocrinology Department at Necker Hospital, with congenital primary and secondary adrenal insufficiency.
* Age between 6 months and 6 years.
* Included in the social security system.
* Parental consent and willingness to participate in this study: involves training and skills in the use of blood glucometers.

Exclusion Criteria:

* Patients with acquired adrenal insufficiency.
* Patients with type 1 or type 2 diabetes.
* Patients with somatotropic deficiency associated with adrenal insufficiency.
* Refusal or impossibility to perform the glycaemic measurements according to the procedure of the study.
* Not covered by the social security system.

Primary outcomes:
measure: Prevalence of hypoglycaemia
timeFrame: 1 year
Secondary outcomes:
measure: Duration of hypoglycaemia
timeFrame: 1 year
measure: Percentage of time in hypoglycaemia
timeFrame: 1 year
measure: Glycemic variations rate
timeFrame: 1 year
measure: Circumstances of occurrence of hypoglycaemia
timeFrame: 1 year
measure: Occurrence of medical events
timeFrame: 1 year
measure: Body Mass Index
timeFrame: 1 year
measure: Systolic and Diastolic Blood Pressure
timeFrame: 1 year
measure: Heart rate
timeFrame: 1 year
measure: Stade tanner
timeFrame: 1 year
measure: Amount of salt consumed per day
timeFrame: 1 year
measure: Cortisol at 8 a.m.
timeFrame: 1 year
measure: Cycle of 17-hydroxyprogesterone
timeFrame: 1 year
measure: Adreno CorticoTropic Hormone
timeFrame: 1 year
measure: 17-hydroxyprogesterone
timeFrame: 1 year
measure: Delta-4-Androstenedione
timeFrame: 1 year
measure: Testosterone
timeFrame: 1 year
measure: Ionogram
timeFrame: 1 year
measure: Renin
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dinane Samara-Boustani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Michel Polak, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.