NCT03411460终止不适用
Satisfaction of Using a Continuous Glucose Monitoring System to Monitor Interstitial Fluid Glucose Level in Hospitalized Insulin-dependent Diabetic Patients Treated Using a Portable Sub-cutaneous Pump
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年4月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Satisfaction of patient-determined hospital care at discharge in the two groups
研究概览
简要总结
The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has given their free and informed consent
- •The patient must be insured or the beneficiary of an insurance policy
- •The patient is aged at least 18 years and less than 75 years old.
- •Patients have a BMI between 18 and 40kg/m2
- •Diabetic patient admitted for glycemic instability with indication for treatment using an external insulin pump but otherwise in a stable clinical state
排除标准
- •The subject is participating in another study
- •The subject is in an exclusion period determined by a previous study
- •The patients is under judicial protection or state guardianship
- •The subject refuses to sign the consent form
- •It proves impossible to give the subject clear information.
- •The patient is pregnant, parturient or breastfeeding
- •The patient is clinically unstable
- •BMI less than 18 or over 40
- •Existence of a severe rapidly progressive ischemic retinopathy or proliferative retinopathy.
- •Serious psychiatric problems
- •Chronic cutaneous infection
研究组 & 干预措施
Interstitial glucose
Experimental
Glucose level tested by continuous monitoring device
干预措施: FreeStyle Libre™ system (Device)
Blood glucose
Active Comparator
Glucose level tested on glucose monitor using standard finger prick
干预措施: Finger prick (Procedure)
结局指标
主要结局
Satisfaction of patient-determined hospital care at discharge in the two groups
时间窗: at discharge from hospital; maximum Day 5
visual analogue scale 0-10
次要结局
- Patient quality of sleep(at each day of hospitalization and discharge; maximum Day 5)
- Satisfaction of nursing staff concerning care of patient(at end of study; maximum Day 5)
- Time taken by nurse to measure circulating glucose level(Daily over length of hospitalization until maximum Day 5)
- Time necessary to achieve satisfactory equilibrium using insulin pump(maximum Day 5)
- Number of glucose readings above 2g/l and below 0.80g/l over the hospital stay(maximum Day 5)
- Number of hypoglycmic events with the corresponding glucose level(maximum Day 5)
- Patient satisfaction concerning treatment for their diabetes(at discharge from hospital; maximum Day 5)
研究者
研究点 (2)
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