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临床试验/jRCTs042210167
jRCTs042210167招募中不适用

An open-label, multicenter, randomized-controlled trial to evaluate the efficacy and safety of a carbohydrate-counting smartphone application with food image recognition system in patients with type 1 diabetes (CARB-LIFE)

未提供0 个研究点目标入组 56 人开始时间: 2022年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
56
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
6age old over 至 70age old not(—)
性别
All

入选标准

  • Patients with type 1 diabetes (acute onset, slowly progressive, and fulminant type 1 diabetes)
  • Patients who have a smartphone (iPhone: iOS12 or later)
  • HbA1c < 10.0%
  • Fasting C-peptide <0.6 ng/ml
  • Patients who recieved caobohydrate-counting instruction at least once

排除标准

  • Patients who are participating other clinical trials using glucose-monitoting devices
  • Patients who are not able to keep appointments to come to their hospitals
  • Patients who have any addictions (dependences) or psychotic disorders

结局指标

主要结局

-

Percentages of the time in targeted glucose range (TIR) 24 weeks after intervention

次要结局

  • Percentages of the time in targeted glucose range (TIR)(12 weeks after intervention)
  • Percentages of the time above targeted glucose range (TAR)(12 and 24 weeks after intervention)
  • Values of HbAc and glycated albumin(12 and 24 weeks after intervention)
  • Percentages of the time below targeted glucose range (TBR)(12 and 24 weeks after intervention)
  • Total daily doses of insulin administration(12 and 24 weeks after intervention)
  • Changes in DTR-QOL scores between before and 24 weeks after intervention(24 weeks after intervention)
  • Body weight and body mass index (BMI)(12 and 24 weeks after intervention)

研究者

发起方
未提供

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