Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study B
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
- 1
- 主要终点
- The percentage of time a participant's glucose value is between 70 and 180 mg/dL will not be inferior to baseline.
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 Welldoc (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
- Supportive Care
- 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 or type 2 diabetes using the Dexcom G6 continuous glucose monitor
排除标准
- •Pregnancy
研究组 & 干预措施
CGM insulin bolus calculator arm
Participants will use the CGM insulin bolus calculator arm
干预措施: BlueStar 10 (Device)
结局指标
主要结局
The percentage of time a participant's glucose value is between 70 and 180 mg/dL will not be inferior to baseline.
时间窗: 30 days
次要结局
未报告次要终点