Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- HbA1c
研究概览
简要总结
The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.
详细描述
This is a post-market, multi-centre, prospective, interventional single arm study in Italy.
Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance.
HbA1c will be tested at the start and end of the study for primary endpoint analysis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 to ≤ 75 years.
- •Type 2 diabetes diagnosis ≥1 year prior to enrolment.
- •Type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment.
- •Current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment.
- •Screening HbA1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days.
排除标准
- •Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment.
- •Currently participating in another study that could affect glucose measurements or glucose management.
- •Currently receiving dialysis treatment or receives dialysis during the study.
- •A female participant who is pregnant.
- •A breastfeeding female participant.
结局指标
主要结局
HbA1c
时间窗: 3 months
Change in HbA1c within group from baseline
次要结局
- Frequency of hypoglycaemia events(3 months)
- Time below range (TBR)(3 months)
- Time in range (TIR)(3 months)
- Time above range (TAR)(3 months)