NCT00726440已完成不适用
Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète38 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 38
- 主要终点
- Comparison of HbA1c mean between the 3 groups
研究概览
简要总结
The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.
详细描述
The primary objective of the study is to determine whether patients with chronically poor glycaemic control as evidenced by HbA1c >= 8% twice can achieve improved metabolic control using during one year CGM together with educative program about insulin adaptation doses compared to conventional self monitoring finger sticks with educative program about insulin adaptation doses alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes for ≥ 12 months or more (including Cpeptide negative secondary diabetes)
- •Children between 8 and 18 years old
- •Adults between 18 and 60 years old
- •Patients treated with basal-bolus insulin regimens, pump or multiple daily injection, only with analogs, for at least 6 months
- •Performing at least 2 finger sticks glucose controls per day
- •Able and motivated to use the device
- •HbA1c ≥ 8% twice with HPLC method(DCA 2000 excluded)
- •Written informed consent obtained prior to enrollment in the study
排除标准
- •Blindness or impaired vision so the screen cannot be recognized
- •Allergy to sensor
- •Active proliferative retinopathy not stabilized by laser or vitrectomy occurence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during study
- •Treatment with systemic corticosteroid or medication known to influence insulin sensitivity in the 3 months prioir to visit 1
- •Pregnancy
- •Manifest psychiatric disturbance
- •Presence of any conditions (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actuel or anticipated that the investigators feels would compromise the patient safety or limit his/her successful participation in the study.
- •Hemoglobinopathy that interfers with HbA1c measurement
结局指标
主要结局
Comparison of HbA1c mean between the 3 groups
时间窗: at 1 year
次要结局
- Comparison of glucose stability in the 3 groups(inclusion, M3, M6, M9, M12)
- Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period(study period)
- Frequency of symptomatic benign hypoglycaemic episodes during the week prior to each visit. inclusion and prior to M3, M6, M9, M12(prior to inclusion and prior to M3, M6, M9, M12)
- Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection(inclusion, M3, M6, M9, M12)
- Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups(inclusion and M12)
- Comparison of weight, insulin doses, in each group(study period)
- comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption(study period)
研究者
研究点 (38)
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