Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency (NCT04322435) | Clinical Trial Compass
CompletedNot Applicable
Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
France9 participantsStarted 2020-07-15
Plain-language 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.
Who can participate
Age range
6 Months – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.