Open Label, Single-center Study of the Onyx Meter and App System for Blood Glucose Monitoring in Insulin-Dependent and Insulin-using, Non-Insulin-Dependent Diabetes Mellitus Patients to Demonstrate Usability in a Clinical Setting.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree.
研究概览
简要总结
The purpose of this study is to assess the usability of the Onyx system in the hands of subjects with Insulin Dependent Diabetes Mellitus (IDDM) or insulin-using subjects with Non-IDDM.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be aged 18-75 years, male or female
- •Read and understand English
- •Have diagnosis of type 1 or insulin-using type 2 diabetes for at least 6 months
- •Be taking multiple daily injections (MDI) of at least two pre-meal bolus injections daily or using an insulin pump
- •Performing self-monitoring of blood glucose at home at least twice daily
- •Have an iOS mobile device or Android mobile device with blue tooth capability
- •iOS device: iPod or iPhone 5 or later version with iOS 8.0 software or higher (no tablets)
- •Android: smart phone, 4.4 version and higher (no tablets)
- •Be willing to utilize the ONYX App on personal mobile device which communicates to meter to manage diabetes (including use of the bolus calculator)
- •Be ambulatory and have transportation to the study site
排除标准
- •Hemophilia or any other bleeding disorder
- •Pregnancy
- •Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM
- •Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
- •A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee on the subject disposition form).
- •Proliferative retinopathy or history of retinal laser surgery
研究组 & 干预措施
Users of Onyx BG Meter / App System
Subjects with diabetes used the Onyx Blood Glucose (BG) Meter / App System at home. The enrollment goal for the intended use population:
- 40 to 70% of subjects will have type 1 diabetes
- Not more than 30% of subjects will use an insulin pump
干预措施: Onyx BG Meter / App System (Device)
结局指标
主要结局
Percent of Responses From Persons Who Performed Each "Software Operations" Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree.
时间窗: 3 weeks
For "software operations" tasks, subjects rated statements about software operations tasks as 1Strongly Agree, 2Agree, 3Neither Agree nor Disagree, 4Disagree, 5Strongly Disagree, or 6No opinion. Software operations tasks included: * Obtain a synced blood glucose reading * Initiation and use of insulin bolus calculator * Access and interpret glucose displays such as expanded graph (modal day) and sequential views.
次要结局
- Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult(3 weeks)
- Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Clarity and Utility of User Instructions For Onyx Glucose Meter and App System(3 weeks)