NCT02665455已完成不适用
Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System - Use in Pregnancy
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
- 83
- 试验地点
- 26
- 主要终点
- Point Accuracy Determined as % Within Consensus Error Grid Zone A
研究概览
简要总结
To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when used at home by pregnant women with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Type 1, type 2 or Gestational Diabetes Mellitus (GDM) (confirmed diagnosis via Oral Glucose Tolerance Test (OGTT))
- •Currently testing Blood Glucose(BG), on average at least 2 times per day
- •Participant is ≥12+0 weeks gestation with a singleton pregnancy
- •In the investigator's opinion, technically capable of using device
排除标准
- •Concomitant disease or condition that may compromise patient safety including and not limited to; cardiac disease or event, sickle cell disease, cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition
- •Currently receiving dialysis treatment or planning to receive dialysis during the study or, moderate to advanced nephropathy (serum creatinine ≥120 micromol/litre or total protein excretion exceeds 2 g/day or urinary albumin:creatinine ratio >30 mg/mmol, estimated glomerular filtration rate (eGFR) may not be used)
- •Diabetic Ketoacidosis (DKA) (in the previous 6 months)
- •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, considering guidelines (e.g. National Institute for Health and Care Excellence (NICE) and International Diabetes Federation(IDF)) for Diabetes in Pregnancy for HbA1c and Blood Pressure
- •Experiencing any of the following conditions for current pregnancy:
- •Pre-eclampsia
- •HELLP syndrome (haemolysis, elevated liver enzymes and low platelet count)
- •Prescribed Tocolytic drugs for treatment of preterm labour
研究组 & 干预措施
Intervention
Experimental
FreeStyle Libre Flash Glucose Monitoring System
干预措施: FreeStyle Libre Flash Glucose Monitoring System (Device)
结局指标
主要结局
Point Accuracy Determined as % Within Consensus Error Grid Zone A
时间窗: 14 days
Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A. Zone A is defined as the zone of "clinical accurate measurements with no effect on clinical action."
次要结局
未报告次要终点
研究者
研究点 (26)
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