Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT04322435
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.
Study:
NCT04322435
Study Brief:
Protocol Section:
NCT04322435