Preliminary Study for the Evaluation of Teleduc-diab Additional Remote Digitalcare Effects in Adolescents With Poorly Controled Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evolution of glycemic control hemoglobin (HbA1c) between inclusion and 6 months
研究概览
简要总结
Pilot study to evaluate effects of an experimental additional remote digital care (TELEDUC-DIAB) to adolescents with poorly controlled type 1 diabetes using digital monitoring platform and educative app
详细描述
The use of digital technologies for the support and monitoring of diabetes have gradually become essential in recent years. The scientific literature reveals contrasting effects of digital and mobile technologies, both on adolescents with T1D (type 1 diabetes) and on their relatives. While the majority of studies have focused on connected devices for continuous blood glucose measurement, the specific effects of other tools, such as those of mobile patient therapeutic education applications or medical telemonitoring, are to this day still poorly documented or even unknown.
The study aim to describe the evolution of the glycemic control of adolescents with poorly controled type 1 diabetes during6 months individual TELEDUC-DIAB remote digital care in addition to their conventional follow-up.
The Medical-educational care (TELEDUC-DIAB) consist of:
- a personalized intensified remote care with a healthcare professional
- myDiabby platform: remote monitoring device integrating a data collection platform and systematized monitoring by alarms
- the Kidia application = a patient therapeutic education mobile application: developed by the Enfance, Adolescence et Diabète association, is a mobile application that patients can personalize (avatar,...) and help them understand and empower to deal with their diabetes.
This project offers original and innovative complementary monitoring: remotely, adapted to the specific needs of adolescents and aimed at improving glycemic control by developing self-efficacy and autonomy in adolescents in the management of diabetes.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent aged ≥12 and <18, with primary type 1 diabetes detected for at least 12 months, treated with multi-injection insulin or insulin pump
- •Glycated hemoglobin greater than or equal to 8% for more than 3 months
- •Use a continuous interstitial glucose recording system (CGM)
- •Have at least one parent/guardian with a significant caregiver role in the management of the adolescent's diabetes (as determined by the investigator) participating in the study
- •Have digital media compatible with the digital applications of the TELEDUC- DIAB (Mobile phone and computer)
排除标准
- •Other pathologies associated with diabetes which, according to the investigator, could interfere with glycemic control or the management of adolescent diabetes (examples: secondary diabetes, cystic fibrosis, Down syndrome; transplants, corticosteroid therapy, etc.)
研究组 & 干预措施
ALL ADOLESCENTS
For all adolescents, the proposed treatment consists, in addition to conventional care,an individual digital care and education(TELEDUC-DIAB)for 6 months using digital devices (myDiabby + Kidia).
干预措施: TELEDUC-DIAB (Other)
结局指标
主要结局
Evolution of glycemic control hemoglobin (HbA1c) between inclusion and 6 months
时间窗: 6 months after inclusion
Glycated hemoglobin (HbA1c) is currently the universally recognized biological marker for monitoring diabetes. Glycated hemoglobin levels will be measured at inclusion, then 6 months after inclusion : a ratio will be deduced 6 months after inclusion with those two measures.
次要结局
- Evolution of knowledge about diabetes and glycemic targets between inclusion and T6 months(6 months after inclusion)
- Evolution of adherence to TELEDUC-DIAB management between inclusion and 6 months(6 months after inclusion)