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临床试验/NCT05708820
NCT05708820招募中不适用

Online Education Programme for People With Type 1 Diabetes and Suboptimal Metabolic Control

Hospital Mutua de Terrassa4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
4
主要终点
HbA1c

研究概览

简要总结

The aim of this study is to evaluate the effectiveness of an online intervention for people with type 1 diabetes who present not optimal control of the disease.

详细描述

Study area: adults with type 1 diabetes, HbA1c >7.5%, >3 years diagnosed. Methods: randomized clinical trial. It will include 60 participants . The improvement of Glycated Haemoglobin in both groups before and after intervention will be compared; adherence to the treatment, quality of life, time in the glycaemic range, perception of hypoglycaemia and knowledge about diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HbA1c ≥7,5%
  • More than 3 years of diagnosis
  • Ability to follow online sessions
  • Having a device to follow up the education programme

排除标准

  • Pregnants
  • People on corticosteroid treatment
  • People with severe disease
  • People with continuous subcutaneous insulin infusion (CSII)

结局指标

主要结局

HbA1c

时间窗: Change from Baseline at 12 months

glycosylated hemoglobin

次要结局

  • Time in Range (TIR)(Change from Baseline at 12 months)
  • Knowledge related to diabetes management(Change from Baseline at 12 months)
  • Awareness of hypoglycemia(Change from Baseline at 12 months)

研究者

发起方
Hospital Mutua de Terrassa
申办方类型
Other
责任方
Sponsor

研究点 (4)

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