Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
Condition: Adrenal Insufficiency, Congenital
MeSH terms: Hypoglycemia; Adrenal Insufficiency
Study type: Interventional

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.
    

Intervention name(s): Continuous blood glucose measurement; Measurement of capillary blood glucose
Intervention type(s): Other; Other
Intervention description(s): 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.
In case of suspicion of hypoglycaemia (parental assessment). Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek Performa strips.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Congenital primary and secondary adrenal insufficiency; Cortisol deficiency; Hypoglycaemia; Children