Study on the Use of Digital Platforms for the Control of Insulin Treatment in Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Potential for improvement of type 1 diabetes through the use of a digital platform
研究概览
简要总结
Type 1 diabetes mellitus is a chronic pathology and represents a constant challenge for children and adolescents with diabetes and their families.
The objective of the treatment of DM1 in pediatric age is to achieve and maintain an optimal glycemic control in order to avoid or delay chronic micro- and macrovascular complications related to the disease.
However, currently, despite technological advances and the development of new insulin formulations, the majority of patients are unable to achieve glycemic goals.
In this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs.
详细描述
Patients are enrolled to a prospective, observational Post-Market clinical Follow-up study. This is a pilot study.
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
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes mellitus
- •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
- •Patients who are able to handle the application on a smart mobile phone.
- •Informed consent is obtained from the patient.
排除标准
- •Patients who, in the opinion of the investigator will not be able to commit to carrying out the follow-ups or do not have adequate technological skills
结局指标
主要结局
Potential for improvement of type 1 diabetes through the use of a digital platform
时间窗: 12 weeks
Percentage of events related to diabetes reported through the use of a digital platform of the total events related to diabetes that occurred between medical visits.
次要结局
- Degree of completion of data related to treatments between medical visits(Day 0 up to Week 12)
- Degree of completion of data related to intercurrent processes between visits(Day 0 up to Week 12)
- Degree of completion of therapeutic adherence between visits(Weekly up to 12 weeks)
- Degree of completion of the questionnaires(Week 12)
- Change in the patient's quality of life scale(Day 0 and week 12)
- Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR(Day 0 and Biweekly up to 12 weeks)
- Percentage of patients who complete the study correctly(Week 12)
- Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV(Day 0 and Biweekly up to 12 weeks)
- Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR(Day 0 and Biweekly up to 12 weeks)
- Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI(Day 0 and Biweekly up to 12 weeks)