Efficacy and Acceptance of Freestyle Libre Abbott Use in Real Life in Type 1 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Aim of the study is to evaluate efficacy of freestyle Libre system (flash glucose monitoring) in real life in term of Glycated Haemoglobin reduction and acceptance of the system evaluated through validated questionnaires after 3 and 6 months of device's use.
详细描述
Freestyle Libre is a new technology developed to monitor glycemic values in diabetic patients.
The system is available in Italy from 2014 but in Veneto region reimbursement for insulin treated diabetic patients is available from august 2017.
International trial (for example Impact trial) demonstrated efficacy of the system (reduction of the time spent in hypoglycemia).
Aim of this study is to evaluate efficacy in real life in term of glycated haemoglobin (HbA1c) reduction. The investigators will enrollee in this trial all type 1 diabetic patients that will start to use the system, on the basis of clinicians decisions and reimbursement criteria.
Investigators will evaluate changes in HbA1c and changes in hypoglycameia fear and therapy acceptance through validated questionnaires after 3 and 6 months of system use
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Male and female participants of at least 18 years of age
- •Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health Organization criteria) for at least 1 year
- •Availability to wear Freestyle Libre sensor
- •Signature of informed consent
排除标准
- •Pregnancy, breastfeeding, intention to undergo pregnancy
- •Known allergies to skin patches or disinfectants used during the study.
- •Skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement
- •Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period.
- •Severe medical or psychological conditions, which, in the opinion of the medical team, may compromise patients' safety while using freestyle LIbre sensor
- •Patients enrolled in other clinical trials.
- •patients that usually wear other continuous glucose monitoring system
结局指标
主要结局
HbA1c
时间窗: after 3 and 6 months
changes in HbA1c values
次要结局
- weight(after 3 and 6 months)
- changes in hypoglycemia fear(after 3 and 6 months)
- changes in therapy satisfaction(after 3 and 6 months)
- hypoglycemic episodes(after 3 and 6 months)
- insulin use(after 3 and 6 months)
研究者
Daniela Bruttomesso
MD, PhD
University of Padova