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
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