Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

  • STATUS
    Recruiting
  • End date
    Jul 15, 2023
  • participants needed
    40
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 25 January 2021

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.

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.

Details
Condition Adrenal Insufficiency, Congenital, Adrenal Insufficiency, Congenital, Adrenal Insufficiency, Congenital
Treatment Continuous blood glucose measurement, Measurement of capillary blood glucose
Clinical Study IdentifierNCT04322435
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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