Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 14
- 主要终点
- Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.
研究概览
简要总结
The aim of this study is to evaluate user preference and ease of use of the FreeStyle InsuLinx system, compared to current methodology, when used at home by subjects with diabetes.
Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with Type 1 or 2 diabetes on a bolus regime (U100 insulin), one or more bolus injections per day for at least 6 months;
- •Age 18 yrs and above;
- •Regularly testing SMBG 3 or more times per day;
- •Willingness to test at least 4 times per day.
排除标准
- •Know to require a bolus injection of more than 50U in a single dose;
- •Has previously used either the InsuLinx or assigned comparison meter;
- •Participated in structured diabetes management training in the last 6 months
- •Is currently on an insulin pump;
- •Has concomitant disease that, in the Investigator's opinion, may compromise patient safety;
- •Is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management;
- •Female subject who is pregnant or planning to become pregnant during the course of the study.
研究组 & 干预措施
ADC, Then Comparator, Then ADC With Calculator
Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
干预措施: ADC blood glucose meter (Device)
ADC, Then Comparator, Then ADC With Calculator
Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
干预措施: Comparator blood glucose meter (Device)
ADC, Then Comparator, Then ADC With Calculator
Subject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
干预措施: ADC blood glucose meter with insulin calculator active (Device)
Comparator, Then ADC, Then ADC With Calculator
Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
干预措施: ADC blood glucose meter (Device)
Comparator, Then ADC, Then ADC With Calculator
Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
干预措施: Comparator blood glucose meter (Device)
Comparator, Then ADC, Then ADC With Calculator
Subject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
干预措施: ADC blood glucose meter with insulin calculator active (Device)
结局指标
主要结局
Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.
时间窗: 25 days
Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.
次要结局
- Preference Questionnaire (Insulin Calculator Not Activated)(25 days (results recorded after the two 7 day periods))