NCT00937703已完成不适用
Multicentric Evaluation of Two Telematics Systems (PDA Phone and IVS)in Type 2 Diabetics Patients in Failure of Oral Treatment and Having to Start a Treatment by Basal Insulin, Compared to a Conventional Care. National, Multicentric, Comparative Randomized Study
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète28 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2008年12月1日最近更新:
适应症
干预措施
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
- 28
- 主要终点
- Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group.
研究概览
简要总结
TELEDIAB-2 is a national, multicenter, controlled, randomised trial. The primary objective of the study is to show that during the initiation of a basal insulin treatment , a computerized decision-making system of adaptation of the insulin, coupled to a distance follow-up (thanks to PDAphone or an interactive vocal server (IVS)), is able to improve metabolic control at the end of 4 mouths as compared with conventional care.
Main judgment criteria: comparison of HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group at 4 months.
详细描述
Secondary objectives :
- - To compare the 2 methods of telemonitoring employed.
- - To evaluate the speed of the glycemic attack of the objective to the rising, according to the method of follow-up employed.
- - To evaluate the satisfaction of the patients and the doctors with respect to systems of telemonitoring, and improvement of the quality of life (DQOL).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes since more than 3 years and claiming a strict balance glycemic;
- •Patients treated since at least 3 months, by metformin and secreting insulinic (KNOWN or glinide);
- •Patients uncontrolled with HbA1c ≥ 7.5% and < 10% at the inclusion.
- •BMI < 40 ;
- •Patients requiring a insulin treatment
- •Patients agree to start a slow insulin treatment
- •Patients already practising the glycemic self-monitoring or agree to learn it and practise it;
- •Patients able to include/understand operation and to use the PDA-phone and/or the SVI;
- •Patient not taking part in another biomedical research study
- •Patients agree to carry out at least 2 finger sticks per day;
- •More than 18 years, there is no higher age limit.
排除标准
- •Patients introducing any evolutionary pathology associated and not stabilized, exhibitor with an uncontrolled diabetes during the year to come;
- •Patients in a situation which justifies of a clinical follow-up diabetologic more frequent than that (quarterly) envisaged by the study
- •Patients requiring a transitory passage to insulin;
- •Patients needing a hospitalization for the adaptation of insulin doses;
- •Patients presenting a cardiologic event
- •Patients presenting a hemoglobinopathy interfering with the proportioning of HbA1c;
- •Patients suffering from drug-addiction, alcoholism or psychological troubles
- •Type 1 or secondary diabetes
- •Patients who don't need strict metabolic objectives;
- •Pregnant or parturient patients
- •person with no freedom.
研究组 & 干预措施
Group1: Control group
Placebo Comparator
face to face visit à T4mounths
干预措施: placebo (Device)
Group2: IVS Group
Active Comparator
face to face visit at T4mounths plus telephone visits each 2 weeks
干预措施: IVS (Device)
Group3: PDAphone group
Active Comparator
PDA system face to face visit at T4mounths plus telephone visits each 2 weeks
干预措施: PDAphone (Device)
结局指标
主要结局
Comparison HbA1c means of the 2 groups profiting from a telemonitoring system compared to the reference group.
时间窗: To T4 months
次要结局
- Comparison of evolution of HbA1c(T0 and T4 months)
- Comparison of the average jeun glycemia the 14 days previous the visit in 4 months(T4 months)
- Comparison of absolute HbA1c difference(T0-T4 months)
- Comparison of percentage of patients within the objective glycemic (the last 3 days Jeun Glycemia average with between 0.73 and 1.08 g/l) at the end of the study, and the average time allowing to achieve this goal(T0 and T4 months)
- Comparison of percentage of patients reaching HbA1c < 7.0% in 4 months(T0 and T4 months)
- Comparison of the evolution of the weight(T0 and T4 months)
- Comparison of evolution of the quality of life at the beginning and at the end of the study (the scale of quality of life DHP as well as the items of dimension Satisfaction of the DQOL)(T0 and T4 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(4 months)
- Comparison of the frequency of benign hypoglycemias, symptomatic or not, night and severe throughout study(study period)
- Comparison of the time spent by physicians with patients during visit (either face to face visits or phone call visit);(study period)
- Comparison of the satisfaction of the patients and physicians with the system and willingness to carry on the use of the system in routine care(4 months)
研究者
研究点 (28)
Loading locations...
相似试验
已完成
2 期
UTOLA: UTerin OLAparibEndometrial CarcinomaNCT03745950ARCAGY/ GINECO GROUP147
已完成
1 期
RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19COVID-19NCT04667247Gordon Saxe54
已完成
2 期
A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus ErythematosusLupus Erythematosus, SystemicNCT03161483Celgene289
撤回
2 期
A Phase II Study to Assess the Efficacy and Safety of Olokizumab in Patients With Crohn's DiseaseCrohn's DiseaseNCT01635621UCB BIOSCIENCES GmbH
已完成
2 期
SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)Sickle Cell DiseaseNCT03806452Theravia86