INTEGRATED IMPACT ASSESSMENT a Telemedicine Program in the Care of Patients With Diabetes Mellitus Type 1 Intensive Treatment With Multiple Daily Injections.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- To analyze the metabolic impact measured through HbA1c of a telemedicine program by MenaDiab® online platform in the care of patients with DM1.
研究概览
简要总结
Prospective study of 6 months of evolution in people with type 1 diabetes with insulin multidose (MDI) and HbA1c> 7%. Patients were evaluated clinical, metabolic and psychological baseline and at 6 months, with a telematic visit at 3 months. We analyzed: glycemic control (HbA1c), glycemic variability (SD and MAGE), depressive symptoms (BDI-II), anxiety (STAI), treatment-related (DDS) distress, fear of hypoglycemia (FH-15), adhesion treatment (SCI-R), quality of life (DQOL) and treatment satisfaction (DTSQ) and the platform.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with DM1 plus 1 year of evolution.
- •Age ≥18 and <65 years.
- •HbA1c prior to study inclusion> 7%.
- •MDI intensive insulin therapy in basal-bolus regimen.
- •Patients candidates for telemonitoring. Approximately 50% of the patients should work with phone or tablet with Android operating system with active data rate to use wireless solution (bluetooth) OnLine MenaDiab® telemedicine. The remaining patients will work with the USB cable solution telemedicine MenaDiab® OnLine.
- •Patients who have given written informed consent.
排除标准
- •Treatment with ISCI.
- •Chronic kidney disease, liver disease, thyroid dysfunction (hypothyroidism except properly treated and controlled).
- •Pregnant or planning pregnancy.
- •Diabetes mellitus type
- •Severe psychological disorders.
- •Lack of cooperation (informed consent).
- •Patients who are participating in other clinical studies.
研究组 & 干预措施
pre-post evaluation
All patients undergo the condition of telemedicine.
干预措施: telemedicine (Device)
结局指标
主要结局
To analyze the metabolic impact measured through HbA1c of a telemedicine program by MenaDiab® online platform in the care of patients with DM1.
时间窗: 6 months
次要结局
未报告次要终点