DETERMINATION OF THE EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring(r) SOFTWARE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.
研究概览
简要总结
The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.
The main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with diabetes in the course of their disease will increase the TIR and/or reduce the number of in-person and telephone visits assisted by specialized medical and nursing personnel.
This is two arms, randomized study. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Retrospective Control group: The data of these patients are collected retrospectively from the last 12 weeks prior to their inclusion.
Researchers will compare the assessments between the two groups to see if the software Caaring® improve the TIR and/or reduce the number of visits to the specialist personnel.
Participants with diabetes will:
Use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems. In addition,
Control group patients must have clinical and glucometry data from the 12 weeks prior to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous glucose monitoring devices Caaring group patients must have sufficient technological skills to use a smartphone.
详细描述
This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial.
The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetes mellitus treated with insulin.
- •Patients treated with subcutaneous insulin in multiple daily doses or patients treated with subcutaneous insulin in continuous subcutaneous infusion systems
- •Patients using a glucose monitoring system
- •Patients who are able to complete the study questionnaires
- •Informed consent is obtained from the patient.
- •For Control group: Patients must have clinical and glucometry data from the 12 weeks prior to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous glucose monitoring devices - For Caaring group: Patients must have sufficient technological skills to use a smartphone.
排除标准
- •Patients with cognitive or sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions or the scales, as long as they do not have a legally authorized representative capable of participating in the study.
- •Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.
- •Patients Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria.
- •Patients whose main diagnosis is a poorly controlled mental disorders or other medical illness.
- •Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).
- •Institutionalized patients
- •Patients who are pregnant or breastfeeding.
- •Patients whose inclusion is not considered advisable by the investigator's assessment due to they are under specific follow-up in other hospital units (hemodialysis, transplants, etc.) that require mandatory hospital attendance less frequently than once every two months.
结局指标
主要结局
Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.
时间窗: 12 weeks
% acceptable Time in Range (TIR) of glucose measurements defined as the percentage of how long the patient's glucose value was within the target range (70-180 mg/dL)
次要结局
- PROs. Changes in Health-related quality of life (HRQOL): EsDQOL(Day 0 and week 12)
- PROs. in Health-related quality of life (HRQOL): KINDL(Day 0 and week 12)
- PROs. Patient satisfaction with the software Caaring(Week 12)
- PROs. Variation in clinical parameters of glycemic control: HbA1c(Day 0 and Week 12)
- PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR(Day 0 and Biweekly up to 12 weeks)
- PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR(Day 0 and Biweekly up to 12 weeks)
- PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT(Day 0 and Biweekly up to 12 weeks)
- PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV(Day 0 and Biweekly up to 12 weeks)
- PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI(Day 0 and Biweekly up to 12 weeks)
- PROs. Number of Medical Visits(Day 0 and Monthly up to 12 weeks)
- PROs. Adherence of treatment(Day 0 and Weekly up to 12 weeks)