Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Prevalence of hypoglycaemia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Adrenal insufficiency
Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years.
干预措施: Continuous blood glucose measurement (Other)
Adrenal insufficiency
Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years.
干预措施: Measurement of capillary blood glucose (Other)
结局指标
主要结局
Prevalence of hypoglycaemia
时间窗: 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).
次要结局
- Body Mass Index(1 year)
- Heart rate(1 year)
- Stade tanner(1 year)
- Percentage of time in hypoglycaemia(1 year)
- Duration of hypoglycaemia(1 year)
- Glycemic variations rate(1 year)
- Circumstances of occurrence of hypoglycaemia(1 year)
- Testosterone(1 year)
- Systolic and Diastolic Blood Pressure(1 year)
- Amount of salt consumed per day(1 year)
- Adreno CorticoTropic Hormone(1 year)
- Cortisol at 8 a.m.(1 year)
- 17-hydroxyprogesterone(1 year)
- Ionogram(1 year)
- Renin(1 year)
- Occurrence of medical events(1 year)
- Cycle of 17-hydroxyprogesterone(1 year)
- Delta-4-Androstenedione(1 year)