跳至主要内容
临床试验/NCT05229445
NCT05229445已完成不适用

Safety of a Real-time Continuous Glucose Monitor-based Insulin Bolus Calculator: The "CGM-IBC" Study

Welldoc2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年7月5日最近更新:
适应症

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

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

研究者

发起方
Welldoc
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验