Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency (GLYSUR)

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Insufficiency, Congenital
• Intervention / Treatment: Other: Continuous blood glucose measurement; Other: Measurement of capillary blood glucose

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Adrenal insufficiency; Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hypoglycaemia	Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.	1 year
Percentage of time in hypoglycaemia	Percentage of time in hypoglycaemia during the continuous blood glucose measurements.	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.	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.	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).	1 year
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
Systolic and Diastolic Blood Pressure	Expressed millimetre of mercury	1 year
Heart rate	Number of beats per minute	1 year
Stade tanner	stade tanner A1 to A5	1 year
Amount of salt consumed per day	Number of grams per day	1 year
Cortisol at 8 a.m.	microgram / deciliter	1 year
Cycle of 17-hydroxyprogesterone	Nanomole per liter	1 year
Adreno CorticoTropic Hormone	Nanogram per liter	1 year
17-hydroxyprogesterone	Nanomole per liter	1 year
Delta-4-Androstenedione	Nanomole per liter	1 year
Testosterone	Nanomole per liter	1 year
Ionogram	Nanomole per liter	1 year
Renin	picogram/milliliter	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Dinane Samara-Boustani, MD, Assistance Publique - Hopitaux de Paris; Study Director: Michel Polak, MD, PhD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

General Publications

• Galderisi A, Kariyawasam D, Stoupa A, Quoc AN, Pinto G, Viaud M, Brabant S, Beltrand J, Polak M, Samara-Boustani D. Glucose pattern in children with classical congenital adrenal hyperplasia: evidence from continuous glucose monitoring. Eur J Endocrinol. 2023 Nov 8;189(5):K19-K24. doi: 10.1093/ejendo/lvad147.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Children; Hypoglycaemia; Congenital primary and secondary adrenal insufficiency; Cortisol deficiency
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Hypoglycemia; Adrenal Insufficiency, Congenital
• Other Study ID Numbers: APHP190910; ID RCB 2019-A02250-57 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No