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Completed

NCT Number: NCT04322435

Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency

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.

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Key information

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous blood glucose measurement

Other

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

Measurement of capillary blood glucose

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.

Primary outcomes

  1. Prevalence of hypoglycaemia

    Time frame: 1 year

    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).

Secondary outcomes

  1. Duration of hypoglycaemia

    Time frame: 1 year

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

  2. Percentage of time in hypoglycaemia

    Time frame: 1 year

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

  3. Glycemic variations rate

    Time frame: 1 year

    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.

  4. Circumstances of occurrence of hypoglycaemia

    Time frame: 1 year

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

  5. Occurrence of medical events

    Time frame: 1 year

    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).

  6. Body Mass Index

    Time frame: 1 year

    Body mass divided by the square of the body height expressed in units of kg/m2 : mass in kilograms and height in meters

  7. Systolic and Diastolic Blood Pressure

    Time frame: 1 year

    Expressed millimetre of mercury

  8. Heart rate

    Time frame: 1 year

    Number of beats per minute

  9. Stade tanner

    Time frame: 1 year

    stade tanner A1 to A5

  10. Amount of salt consumed per day

    Time frame: 1 year

    Number of grams per day

  11. Cortisol at 8 a.m.

    Time frame: 1 year

    microgram / deciliter

  12. Cycle of 17-hydroxyprogesterone

    Time frame: 1 year

    Nanomole per liter

  13. Adreno CorticoTropic Hormone

    Time frame: 1 year

    Nanogram per liter

  14. 17-hydroxyprogesterone

    Time frame: 1 year

    Nanomole per liter

  15. Delta-4-Androstenedione

    Time frame: 1 year

    Nanomole per liter

  16. Testosterone

    Time frame: 1 year

    Nanomole per liter

  17. Ionogram

    Time frame: 1 year

    Nanomole per liter

  18. Renin

    Time frame: 1 year

    picogram/milliliter

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: GLYSUR

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2020
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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