NCT00629304已完成3 期
Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète36 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 36
- 主要终点
- Comparison of HbA1c mean between the 3 groups
研究概览
简要总结
TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.
Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months
详细描述
Secondary Objectives :
- To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system
- To assess the improvement in diabetes care provided by the use of the PDA-FIT system
- Satisfaction of patients and physicians towards the PDA-FIT system
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes mellitus for ≥ 12 months or more (including C-peptide negative secondary diabetes)
- •age > 18 y.o.
- •intensive insulin basal-bolus therapy for ≥ 6 months. At inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
- •chronically uncontrolled diabetes with HbA1c ≥ 8 % during the past 12 months and at inclusion
排除标准
- •patient with unstable associated evolutive pathology
- •patient who need a more frequent diabetic follow up (than in the protocol)
- •patient with a education teaching within the 3 months before inclusion
- •patient with a hemoglobinopathy
- •patient with toxicomania, alcoholism or psychological troubles
- •type 2 diabetes patients
- •patient who don't need strict metabolic objectives
- •pregnant or parturient women
- •person with no freedom (prisoner)
结局指标
主要结局
Comparison of HbA1c mean between the 3 groups
时间窗: at 6 months
次要结局
- Absolute HbA1c differences (M0-M6)(inclusion and M6)
- HbA1c changes at M0, M3 and M6(inclusion, M3 and M6)
- Percentage of patients reaching HbA1c <7.5% at 6 months(6 months)
- Mean of blood glucose values as provided by glucose meters during the 14 days prior to inclusion and prior to the 6 months-visit(14 days prior to inclusion and prior to M6)
- 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 inclusion and prior to the 6 months-visit(week before inclusion and prior to M6)
- 8-point blood glucose profiles at inclusion and 6 months(inclusion and M6)
- Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire(inclusion and M6)
- Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory(study period)
- Time spent by physicians with patients during visits (either face to face visits or phone call visits) and time spent by patients during transport, waiting time and lost working time(study period)
- Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care(6 months)
- Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician(6 months)
研究者
研究点 (36)
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