Evaluation of Long-term Efficacy of 2 Strategies of Real Time Continuous Glucose Monitoring, Compared to Self BG-monitoring in Children and Adolescent With Type 1 Diabetes: a Randomized, Multicenter, Open Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Comparison of the effect of 2 strategies of real time continuous glucose monitoring vs conventional SMBG on glycated haemoglobin = HbA1c measured at inclusion, 3, 6, 9, 12 months
研究概览
简要总结
Glycemic control in children and adolescent with type 1 diabetes remains inadequate, exposing them to the risk of vascular complications in adulthood.
One of the limiting factors is the daily number of self measurements of blood glucose required to optimize intensive insulin therapy.
Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation. A randomized clinical study has shown its efficacy at short term (3 months). However, optimal clinical use of these devices requires rigorous assessment of their effectiveness on glycemic control, tolerance and acceptability in medium and long term.
Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM (continuous or discontinuous) on glycemic control compared to conventional blood glucose self-monitoring (SMBG).
Population: Children and adolescents with type 1 diabetes with inadequate glycemic control despite intensive insulin therapy.
详细描述
Despite the development of intensive insulin therapy, glycemic control defined by glycated haemoglobin (HbA1c) < 7,5% remains inadequate in pediatric patients with type 1 diabetes.
Improvement of the metabolic control is limited by the daily number of self measurements of blood glucose required to adjust closely insulin therapy
Improving glycemic control is particularly important in type 1 children and adolescent, whose risk of vascular complications in adulthood is high, due to the duration of the disease and whose adherence to current strategies of blood glucose self-monitoring is limited.
Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation. A randomized clinical study has shown improvement of HbA1c (≈ 1%) without increasing frequency of hypoglycaemia after continuous use for 3 months. Optimal clinical use of these new devices requires rigorous assessment of their effectiveness on glycemic control, tolerance and acceptability at medium and long term.
Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM on glycemic control compared to conventional blood glucose self-monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 years and 17 years 11 months.
- •Onset of type 1 diabetes ≥ 1 year.
- •Centralized HPLC HbA1c ≥ 7.5% and < 11%.
- •Intensive insulin therapy either by multiple daily injections ≥ 3 / day (rapid insulin analogue before 3 meal and 1 to 2 injections of basal insulin) or by continuous subcutaneous insulin infusion (pump).
- •Followed in the centre for ≥ 3 months.
- •Blood glucose self-monitoring ≥ 2/day.
- •No significant change of regimen insulin therapy for at least 3 months.
- •Patient receiving medical health insurance.
- •Patient who has given his consent
排除标准
- •Non type 1 diabetes(type 2 diabetes or diabetes whose evolution suggest other origin).
- •Association with another pathology which, in the discretion of the investigator, could affect the monitoring or be disturbed by the participation in the study.
- •Association with chronic treatment (steroids, growth hormone...) or chronic disease, including hypothyroidism and celiac disease, non stabilized for 3 months.
- •Association with severe skin disease.
- •Deafness, hearing or visual defect.
结局指标
主要结局
Comparison of the effect of 2 strategies of real time continuous glucose monitoring vs conventional SMBG on glycated haemoglobin = HbA1c measured at inclusion, 3, 6, 9, 12 months
时间窗: 1 year
次要结局
- Average blood glucose and glycemic variability(1 year)
- HbA1c and associated factors with HbA1c changes, others parameters of glycemic control, tolerance, acceptability, quality of life, satisfaction after use of real time continuous glucose monitoring in 150 pediatric patients(3 months)
- Frequency of non-severe or symptomatic hypoglycaemia(1 year)
- Tolerance of using the device of continuous glucose monitoring (skin tolerance)(1 year)
- Satisfaction to use the device(1 year)
- Acceptability of the device (percentage of time of use)(1 year)
- Medico-economic evaluation(1 year)
- Frequency of acute metabolic events (severe hypoglycaemia or ketoacidosis)(1 year)
- General and diabetes-related Quality of life(1 year)