Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency (GLYSUR)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Adrenal Insufficiency, Congenital

Treatments: Other: Measurement of capillary blood glucose; Other: Continuous blood glucose measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04322435

ID RCB 2019-A02250-57 (Other Identifier)

APHP190910

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Adrenal insufficiency

Other group

Description:

Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years.

Treatment:

Other: Continuous blood glucose measurement

Other: Measurement of capillary blood glucose