Feasibility and Effectiveness of Tele-diabetes Remote System on Glycemic Control and Quality of Life of Children and Youth With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Glycemic control
研究概览
简要总结
The goal of this clinical trial is to examine the feasibility and effectiveness of a tele-diabetes remote monitoring system on managing type 1 diabetes (T1DM) among children and adolescents. The study aims to assess whether this system, which incorporates a WhatsApp-based alert system, can improve clinical outcomes, increase adherence to treatment, enhance quality of life, and reduce healthcare utilization in this population. The main questions it aims to answer are:
Does the tele-diabetes remote system improve glycemic control (e.g., time in range [TIR], frequency of hypoglycemia and hyperglycemia, HbA1c levels)? Does it enhance adherence to treatment and overall quality of life for children and youth with T1DM? Does the system reduce the number of emergency room visits for diabetic ketoacidosis (DKA) or severe hypoglycemia, hospitalizations, and overall medical costs? Researchers will compare participants who receive WhatsApp notifications (intervention group) with those receiving standard care (control group) to evaluate differences in clinical outcomes, quality of life, and healthcare burden.
Participants will:
Receive notifications via WhatsApp messages sent by a system developed by the research team, which monitors glucose trends in real-time and sends alerts when patterns (e.g., hypoglycemia, hyperglycemia) are detected.
Participate in follow-ups supported by the hybrid medical team between routine clinic visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a confirmed diagnosis of Type 1 Diabetes Mellitus (T1DM).
- •Participants must use Dexcome Continuous Glucose Monitoring (CGM)
- •Must have access to a smartphone capable of receiving WhatsApp messages.
- •Participants must use a closed-loop insulin pump system (also known as an artificial pancreas system) omnipod DIY or Tandem.
排除标准
- •Participants who are not using Dexcome Continuous Glucose Monitoring (CGM) and a closed-loop insulin pump system
研究组 & 干预措施
intervention
trends (e.g., hyperglycemia, hypoglycemia) and send automated WhatsApp alerts
干预措施: Tele-diabetes Remote System (Behavioral)
Control
Participants in this arm will continue with standard care for managing Type 1 Diabetes
结局指标
主要结局
Glycemic control
时间窗: Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.
CGM data - TIR - time in range, TIIR- time in tight range , hypoglycemia and hyperglycemia events, GMI, CV
次要结局
- Adherence to Treatment(Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.)
- Number of emergency room visits with diabetic ketoacidosis (DKA) or hypoglycemia(Baseline (prior to receipt of the first WhatsApp alert) and monthly assessments after the first alert, at 1 month, 2 months, and 3 months post-enrollment.)
- Satisfaction score(3 months post-enrollment.)
- Number of hospitalizations(3 months past enrollment)