Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
- Conditions
- Adrenal Insufficiency, Congenital
- Interventions
- Other: Continuous blood glucose measurementOther: Measurement of capillary blood glucose
- Registration Number
- NCT04322435
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adrenal insufficiency Measurement of capillary blood glucose Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years. Adrenal insufficiency Continuous blood glucose measurement Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years.
- Primary Outcome Measures
Name Time Method Prevalence of hypoglycaemia 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 Outcome Measures
Name Time Method Body Mass Index 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
Heart rate 1 year Number of beats per minute
Stade tanner 1 year stade tanner A1 to A5
Duration of hypoglycaemia 1 year Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.
Percentage of time in hypoglycaemia 1 year Percentage of time in hypoglycaemia during the continuous blood glucose measurements.
Glycemic variations rate 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.
Circumstances of occurrence of hypoglycaemia 1 year Circumstances in which hypoglycaemia occurred : descriptive data by parents, symptomatic or not symptomatic hypoglycaemia, descriptive signs if they are presents.
Testosterone 1 year Nanomole per liter
Systolic and Diastolic Blood Pressure 1 year Expressed millimetre of mercury
Amount of salt consumed per day 1 year Number of grams per day
Adreno CorticoTropic Hormone 1 year Nanogram per liter
Cortisol at 8 a.m. 1 year microgram / deciliter
17-hydroxyprogesterone 1 year Nanomole per liter
Ionogram 1 year Nanomole per liter
Renin 1 year picogram/milliliter
Occurrence of medical events 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).
Cycle of 17-hydroxyprogesterone 1 year Nanomole per liter
Delta-4-Androstenedione 1 year Nanomole per liter
Trial Locations
- Locations (1)
Hôpital Necker-Enfants Malades
🇫🇷Paris, France