Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

NCT ID: NCT04322435

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2022-08-31

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.

Conditions

Adrenal Insufficiency, Congenital

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Continuous blood glucose measurement

Intervention Type: OTHER

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

Measurement of capillary blood glucose

Intervention Type: OTHER

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.

Interventions

Continuous blood glucose measurement

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dinane Samara-Boustani, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Michel Polak, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 37952170 (View on PubMed)

Other Identifiers

ID RCB 2019-A02250-57

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190910

Identifier Type: -

Identifier Source: org_study_id