Organisational Models Supported by Technology for the Management of Diabetic Disease and Its Complications in a Diabetic Clinic Setting. A Randomised Controlled Trial Targeting Type 2 Diabetes Individuals With Non-ideal Glycemic Values
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Haemoglobin glycated (Hb1Ac) mean changes
研究概览
简要总结
The goal of this randomised trial is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organizational asset for poorly controlled type 2 diabetes individuals in the Autonomous Province of Trento (PAT). The main question aims to answer whether individuals using the "TreC Diabete" platform will improve their haemoglobin glycated level (Hb1Ac) at 12-month post-randomisation. Participants will be asked to perform some tasks and to share their data with the healthcare staff members through the platform. Control group will receive standard care.
详细描述
Type 2 diabetes mellitus (T2DM) is a non-communicable disease representing one of the most serious public health challenges of the 21st century. Its incidence continues to rise in both developed and developing countries, causing the death of 1.5 million people every year. The use of technology (e.g. Smartphone application - App) in the health field has progressively increased as it has been proved effective in helping some individuals manage their long-term diseases. Therefore, it has the potential to reduce health service utilization and its related costs. The objective of this study is to evaluate the impact of using a digital platform called "TreC Diabete" embedded into a novel organizational asset targeting poorly controlled T2DM individuals in the Autonomous Province of Trento (PAT), Italy.This trial was designed as a multi-center, open-label, randomised, superiority study with two parallel-groups and a 1:1 allocation ratio. Individuals regularly attending outpatients diabetes clinics, providing informed consent are randomised to be prescribed TreC Diabete platform or not as part of their personalised care plan. Healthcare staff members will remotely assess the data shared by the participants through the App by using a dedicated online medical dashboard. The primary end-point is the evaluation of the Hb1Ac level at 12-month post-randomisation. Data will be analysed on an intention-to-treat (ITT) basis.This trial is the first conducted in the PAT for the use of an App specifically designed for individuals with poorly controlled T2DM. If the effects of introducing this specific App within a new organizational asset are positive, the digital platform will represent a possible way for people diagnosed with T2DM to better manage their health in the future. Results will be disseminated through conferences and peer-reviewed journals once the study is completed.
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being diagnosed with T2DM;
- •aged ≥ 18 and ≤ 85 years old;
- •having an HbA1c level >7% (53 mmol/mol) and <12% (108 mmol/mol);
- •being able to walk without walking aids;
- •having provided written informed consent;
- •having a smartphone or a tablet and being able to download the App that will be used to insert the required data.
排除标准
- •having a BMI <18 Kg/m² and >45 Kg/m²;
- •having a sBP <100 or >200 mmHg and/or dBP <50 or >120 mmHg;
- •being diagnosed with a stage 5 CKD*
- •being diagnosed with a NYHA stage IV;
- •poor collaboration (ie unwilling to modify the actual plan of control and therapy, even if not ideal) for which adherence to the study is unlikely
- •having no possibility of using a smartphone or a tablet
- •having medical conditions affecting the study participation (i.e. life expectancy < 1 year)
结局指标
主要结局
Haemoglobin glycated (Hb1Ac) mean changes
时间窗: 12 months
Difference in the participants' HbA1c level between the two arms. Blood test carried out by qualified nurses and processes by the local analysis laboratory. Blood tests results are automatically registered on the Hospital Information System (HIS) and reviewed by clinicians and research staff involved in the study.
次要结局
- Number of subjects reaching targeted lipid profile(12 months)
- Satisfaction and usability score of the App(12 months)
- Number of hypoglycemic episodes(12 months)
- Proportion of participants with Hb1Ac <53mmol/mol(12 months)
- Quality of life score changes(12 months)
- Number of changes in the therapeutic plan(3 months, 6 months, 9 months and 12 months)
- Time spent for telemedicine visits(6 months)
- Hb1Ac mean changes(3 months, 6 months and 9 months)
- Level of physical activity(3 months, 6 months, 9 months and 12 months)
- Number of (tele)specialist consultations(3 months, 6 months, 9 months and 12 months)
- Number of subjects reaching targeted blood pressure levels(3 months, 6 months, 9 months, 12 months)
- Effect on weight(3 months, 6 months, 9 months and 12 months)
- Number of telemedicine visits between participants and nurses/clinicians and chat interactions(3 months, 6 months, 9 months and 12 months)
研究者
Inchiostro Sandro
Doctor
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento