Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- time in range
研究概览
简要总结
This study examines the safety of an app-based insulin bolus calculator that utilizes glucose values from a continuous glucose monitor
详细描述
Individuals with type 1 diabetes and those with type 2 diabetes who are prescribed bolus insulin must decide on an insulin dose for any given meal. This dose is often based on what they are eating and their glucose value. Insulin bolus calculators may be helpful in recommending an insulin dose. This study examines the safety of an app-based insulin calculator manufactured by Welloc (Columbia, MD). This app uses the glucose value and trend arrow, in certain circumstances, to recommend a bolus insulin dose. This study is a single arm trial where continuous glucose monitoring metrics such as time in range will be measured before and after the study participants are given the app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes
- •type 2 diabetes
- •using Dexcom G6 CGM system
- •injecting bolus insulin
排除标准
- •pregnancy,
- •insulin pump use
结局指标
主要结局
time in range
时间窗: 30 days
time in range using the calculator app will be non-inferior to baseline time in range
次要结局
未报告次要终点
