NCT01519466已完成不适用
Impact of a built-in Insulin Calculator Feature on Diabetes Control - Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Time in Target Blood Glucose Range
研究概览
简要总结
The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
- •HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
- •Age 18 and over
- •In the investigator's opinion, thought technically capable of using masked CGM
- •Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
- •Willing to perform a minimum of 4 SMBG tests per day during study
排除标准
- •Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
- •Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
- •Subject is pregnant / planning to become pregnant within the planned study timeline
- •Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
- •Subject is currently on an insulin pump
- •Subject is currently using the FreeStyle InsuLinx
- •Subject is currently using the FreeStyle Freedom Lite
- •Subject is currently using CGM
- •Subject has an allergy to medical grade adhesives
结局指标
主要结局
Time in Target Blood Glucose Range
时间窗: Day 1-15 compared with Day 60-74
Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)
次要结局
- HbA1c(Day 1 compared with Day 74)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.(Day 60 compared to day 1)
研究者
研究点 (8)
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