Randomized Crossover Clinical Trial in Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion to Assess the Impact of Telemedicine vs. Conventional Medical Care. Integral Clinical Impact and Cost
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).
研究概览
简要总结
Diabetes mellitus is a chronic disease of high socio-health relevance for their clinical and economic implications (risk of complications, disability ...) (healthcare costs). Strict glycemic control and intensive treatment and support have shown long-term patient with type 1 diabetes mellitus (DM1) improved health. The intensive insulin therapy involves the administration of insulin through 3 or more injections per day (MDI), or through a continuous subcutaneous insulin infusion (CSII). New technologies applied to the treatment of DM1, such as telemedicine, could bring benefits to patients. The available scientific evidence to date shows that telemedicine systems have beneficial or neutral effects on glycemic control, expressed in terms of HbA1c in patients with type 1 diabetes treated with MDI or CSII. They have also shown not to worsen the quality of life and reduce the costs associated with the care of these subjects. However, studies published to date are generally short follow-up, small sample size, and have not evaluated other biological parameters such as glycemic variability, inflammatory markers and markers of oxidative stress as well as a psychological assessment including depression, anxiety, Diabetes-related distress and fear of hypoglycemia. It has been designed a randomized crossover 18 months in order to study the effect of a telemedicine program in a group of subjects with DM1 in CSII on clinical variables of metabolic control variables, including parameters of glycemic variability, markers of inflammation and oxidative stress, psychological variables and quality of life, and associated costs.
详细描述
Randomized crossover clinical trial about the impact of a telemedicine program (Emminens Conecta® System, Roche Diagnostics SL) vs. the conventional medical follow-face of 18 months for the care of patients with DM1 intensive treatment with CSII (Accu-Chek Spirit®, Roche SL).
Two groups: one group with interactive clinical monitoring through a telemedicine platform (TM) and other conventional medical follow-up group (SMC) during 6 months. Being a crossover trial, both groups passing through both conditions (TM and SMC) during 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes over 2 years of development with C plasma levels <0.5 ng / ml, and ISCI treated for> 6 months peptide.
- •Age between 16 and 65 years (inclusive).
- •HbA1c <10%.
- •Absence of concomitant drug therapy that could affect blood glucose levels.
- •Absence of chronic renal failure, abnormal liver function tests, thyroid disease active (except properly replaced hypothyroidism).
- •Absence of acute decompensation Ketotic at baseline.
排除标准
- •type 2 diabetes.
- •type 1 diabetes treated with multiple daily insulin injections.
- •Women pregnant or planning pregnancy.
- •severe macrovascular or microvascular complications
- •disabling psychological disorders.
- •No collaboration (not signed informed consent).
结局指标
主要结局
Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).
时间窗: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
次要结局
- Assessment of inflammatory markers (IL-6).(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of redox markers (CAT).(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of depression with the BDI-II(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of inflammatory markers (hs-CRP).(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of quality of life with the DQOL(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of inflammatory markers (MCP-1).(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of redox markers (oxidized LDL).(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of anxiety with the STAI(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of distress related to diabetes with the DDS(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of inflammatory markers (TNF-α).(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of redox markers (TBARS).(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of treatment satisfaction with the DTSQ(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of fear of hypoglycemia with the FH-15(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))
- Assessment of cost-effectiveness with a structured interview designed by our research group of direct and indirect costs.(6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b))