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Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

NCT04322435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Adrenal Insufficiency, Congenital

Interventions

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.

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Dinane Samara-Boustani, MD · Assistance Publique - Hôpitaux de Paris

  • Michel Polak, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-15
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04322435 on ClinicalTrials.gov