Hypocortisolism, adrenal insufficiency E27
Conditions
Interventions
Group 1: Children and adolescents aged 2 to 17 with primary or secondary adrenal insufficiency and continuous cortisone replacement therapy wear a continuous glucose monitoring system after informed c
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of central or primary adrenal insufficiency. Hypocortisolism should be treated permanently (for 3 months) with hydrocortisone or another cortisone preparation
Exclusion criteria
Exclusion criteria: Acute derailments during the last 7 days. Patients with congenital adrenal hyperplasia (CAH) will not be able to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the effect of intermediate diagnostic, blinded continuous glucose monitoring (CGM) use in children and adolescents with primary or secondary adrenal insufficiency. After a regular appointment in the outpatient clinic and starting the CGM sensor, continuous glucose data are recorded over 10 days in everyday life. The primary outcome is the detection of otherwise unnoticed hypoglycemia (timing, duration, and frequency). While wearing the CGM, ketone measurements in morning urine are performed to rule out ketotic hypoglycemia. CGM data are downloaded at a second appointment after 10 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of the frequency, timing, and duration of hyper- and hypoglycemic events and ketonuria during 10 days of continuous glucose monitoring, also in relation to treatment data. | — |
Countries
Germany
Contacts
Public ContactChristina Reinauer
Universitätsklinikum Düsseldorf
Outcome results
None listed