Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

Assistance Publique - Hôpitaux de Paris9 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Adrenal Insufficiency, Congenital

Interventions

Continuous blood glucose measurementOTHER

Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.

Measurement of capillary blood glucoseOTHER

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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hôpital Necker-Enfants Malades

Paris, France

Outcomes

Primary Outcomes

Prevalence of hypoglycaemia

Number of hypoglycaemic events. Hypoglycaemia will be defined by a glucose level measured at a glucose level of less than or equal to 0.55 g /L (3 mmol /L).

Time frame: 1 year

Secondary Outcomes

Duration of hypoglycaemia

Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.

Time frame: 1 year

Percentage of time in hypoglycaemia

Percentage of time in hypoglycaemia during the continuous blood glucose measurements.

Time frame: 1 year

Glycemic variations rate

Glycemic variations rate during the different measurements times: minimum rate, maximum rate, average, median. Each result will be expressed in g /L or in mmol /L. Each date will expressed by one day and for one week.

Time frame: 1 year

Circumstances of occurrence of hypoglycaemia

Circumstances in which hypoglycaemia occurred : descriptive data by parents, symptomatic or not symptomatic hypoglycaemia, descriptive signs if they are presents.

Time frame: 1 year

Occurrence of medical events

Events during the follow-up of the study: modification of treatment of hydrocortisone and fludrocortisone, re-sugaring expressed in number of sugar cubes ( by sugar cube = 20 gr of sugar) or type of sweet food given to the child, hospitalizations ( type and reason for hospitalization, cause of the decompensation).

Time frame: 1 year

Body Mass Index

Data from ClinicalTrials.gov

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