Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

Adrenal Insufficiency, Congenital Clinical Trial

— GLYSUR  

Official title:

Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04322435
• Other study ID #: APHP190910
• Secondary ID: ID RCB 2019-A022
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Adrenal Insufficiency, Congenital
• Hypoglycemia

Intervention

Other:
• Continuous blood glucose measurement
Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.
• Measurement of capillary blood glucose
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.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year
Secondary	Duration of hypoglycaemia	Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.	1 year
Secondary	Percentage of time in hypoglycaemia	Percentage of time in hypoglycaemia during the continuous blood glucose measurements.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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).	1 year
Secondary	Body Mass Index	Body mass divided by the square of the body height expressed in units of kg/m2 : mass in kilograms and height in meters	1 year
Secondary	Systolic and Diastolic Blood Pressure	Expressed millimetre of mercury	1 year
Secondary	Heart rate	Number of beats per minute	1 year
Secondary	Stade tanner	stade tanner A1 to A5	1 year
Secondary	Amount of salt consumed per day	Number of grams per day	1 year
Secondary	Cortisol at 8 a.m.	microgram / deciliter	1 year
Secondary	Cycle of 17-hydroxyprogesterone	Nanomole per liter	1 year
Secondary	Adreno CorticoTropic Hormone	Nanogram per liter	1 year
Secondary	17-hydroxyprogesterone	Nanomole per liter	1 year
Secondary	Delta-4-Androstenedione	Nanomole per liter	1 year
Secondary	Testosterone	Nanomole per liter	1 year
Secondary	Ionogram	Nanomole per liter	1 year
Secondary	Renin	picogram/milliliter	1 year