Assessment of the Impact of Food Carbohydrate and Insulin Dose Computing by an Application on Smart Phone on Glucose Control in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2-hour postmeal blood glucose values between 80 and 180 mg/dl
研究概览
简要总结
During this study, we will assess a new smart phone application which aims at helping patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients, already trained to carbohydrate counting, will be recruited among those who have been using this method daily for at least 6 months. They will complete two one-month study phases, using the application in one phase and counting carbohydrate and insulin doses without the application in the other phase, with randomized order of each phase. Visits are scheduled at the start and at the end of each phase to collect data on glucose control and insulin doses. Questionnaires assessing health-related quality of life and ability of self-management of diabetes will also be filled by patients before and after each study phase.
详细描述
During this study, we will assess a new smart phone application which aims at helping patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients, already trained to carbohydrate counting, will be recruited among those who have been using this method daily for at least 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes since more than 1 year
- •Basal-bolus insulin regimen since more than 6 months
- •Daily practice of food carbohydrate counting since more than 6 months
- •HbA1c level below 12%
排除标准
- •Type 2 diabetes
- •No ability to use a smart phone
- •Pregnancy or lactation
- •Severe psychiatric disorders
- •Eating disorders
- •Alcohol abuse or recreational drug use
研究组 & 干预措施
Use of smart phone application (device glucal)
Before each meal patient will enter in the application food intakes. Automated carbohydrate and meal insulin dose computing according to individual meal insulin/carbohydrate ratio.
During the first month, then during the second month they'll use as usual their traintement and meal without the apllication
干预措施: Automated carbohydrate and meal insulin dose computing (Device)
Use of smart phone application (second month)
During the first month they'll use as usual their traintement and meal without the apllication ,then during the second month they'll use the apllicatioin.
Before each meal patient will enter in the application food intakes. Automated carbohydrate and meal insulin dose computing according to individual meal insulin/carbohydrate ratio.
干预措施: Automated carbohydrate and meal insulin dose computing (Device)
结局指标
主要结局
2-hour postmeal blood glucose values between 80 and 180 mg/dl
时间窗: 4 weeks
Percent 2-hour postmeal blood glucose values between 80 and 180 mg/dl during 4 weeks
次要结局
- Mean 2-hour postmeal blood glucose level(4 weeeks)