NCT02434315已完成不适用
Evaluation of the FreeStyle Libre Pro for Individuals With Insulin Managed Type 2 Diabetes in Primary & Secondary Care
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 23
- 主要终点
- Change from Baseline - time in glucose range - for penultimate sensor wear
研究概览
简要总结
The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro wear as measured by time in range.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age at least 18 years.
- •Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
- •HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
排除标准
- •Age at least 18 years.
- •Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment.
- •HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive.
- •Participant is currently prescribed animal insulin.
- •Total daily dose of insulin (TDD) is >1.75 iu/kg at entry to the study.
- •Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition.
- •Has a pacemaker or any other neurostimulators.
- •Currently prescribed oral, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period.
- •Currently receiving dialysis treatment or planning to receive dialysis during the study.
- •Women who are pregnant, plan to become pregnant or become pregnant during the study.
- •Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
- •Currently using / has previously used a sensor based Glucose Monitoring System (including retrospective glucose monitoring system) within the last 6 months.
- •Currently using Continuous Subcutaneous Insulin Infusion (CSII).
- •Known (or suspected) allergy to medical grade adhesives.
- •In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason.
研究组 & 干预措施
Group A - Control
Active Comparator
FreeStyle Libre Pro 3 sensor wears
干预措施: FreeStyle Libre Pro 3 sensor wears (Device)
Group B - Intervention
Experimental
FreeStyle Libre Pro 4 sensor wears, 2 with reviews
干预措施: FreeStyle Libre Pro 4 sensor wears, 2 with reviews (Device)
Group C - Intervention
Experimental
FreeStyle Libre Pro 6 sensor wears, 4 with reviews
干预措施: FreeStyle Libre Pro 6 sensor wears, 4 with reviews (Device)
结局指标
主要结局
Change from Baseline - time in glucose range - for penultimate sensor wear
时间窗: 14 day baseline phase compared to day 172 to 187
Within arm difference in time in range in penultimate period of sensor wear compared to baseline phase
次要结局
未报告次要终点
研究者
研究点 (23)
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