SMARTCLOTH. Design, Implementation and Study of the Effectiveness and Usability of a Digital Tablecloth for Self-management of Diet in Diabetic Patients.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 90
- 试验地点
- 10
- 主要终点
- glycated hemoglobin
研究概览
简要总结
The objective of this clinical trial is to know the usability and efficacy of SMARTCLOTH for better control and adherence to the dietary patterns recommended to patients with diabetes, both the portion diet system (more common for cases of Diabetes Mellitus type 1 -DM1-), and the plate method (more recommended in cases of Diabetes Mellitus type 2-DM2-). The main questions are:
- Does the use of SMARTCLOTH improve glycemic control in patients with diabetes mellitus?
- Do patients with diabetes mellitus find SMARTCLOTH useful in their daily lives?
The researchers will compare changes over 3 months in variables related to glycemic control in two groups, one using SMARTCLOTH (intervention group) and the other following standard recommendations (control group). To do so, participants will have to:
- Use SMARTCLOTH for 3 months or follow the recommendations they receive from their referring health professionals.
- Come back after three months for a check-up of the chosen variables.
- The experimental group should contact the investigators in case the hardware has any problems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 1 and 2 diabetes (eligible population) aged between 18 and 70 years with disease progression not exceeding 15 years and HbA1c greater than 7.5.
排除标准
- •Degree of dependence (physical or psychological) that makes it impossible for them to perform autonomous self-care of the dietary-nutritional regimen.
- •Oncological or autoimmune disease, chronic renal insufficiency, transplant patients and others that alter the values of the result variables or may constitute a confounding factor.
- •Other diseases that entail surgical interventions or hospital admissions that make it impossible to follow up the study.
- •Patients with complications due to the evolution of the diabetic pathology: retinopathy, nephropathy, polyneuropathy, ischemic heart disease, as well as other micro and macrovascular complications derived from the same and already recorded in the patient.
- •Those subjects subjected to specific dietary regimes such as celiac disease, lactose intolerant, etc.
结局指标
主要结局
glycated hemoglobin
时间窗: From enrollment to the end of treatment at 3 months
The test shows an average of the blood sugar level over the past 90 days and represents a percentage. The test can also be used to diagnose diabetes
次要结局
未报告次要终点