Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 469
- 试验地点
- 25
- 主要终点
- HbA1c
研究概览
简要总结
A prospective multi-centre, open-label, two arm, parallel design, superiority, pragmatic, randomised controlled trial, over an 8-month period. The purpose of this study is to determine whether continuous glucose monitoring using FreeStyle Libre 3 will improve HbA1c compared to SMBG over 16 weeks in adults with sub-optimally controlled (HbA1c 7.5-11%) Type 2 diabetes on basal therapy.
Following completion of the 8-month period for all participants, an optional non-interventional follow-up period will assess glycaemic control and treatment patterns over 24 months.
详细描述
The study will assess change in HbA1c as the primary endpoint. Other endpoints related to glycaemic control are included in the analyses. The study is split into two phases each of four months duration: participant-driven (phase 1) and HCP/therapy-driven (phase 2). Participants will be randomised to either FreeStyle Libre 3 or to continuation with their current SMBG device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Aged 18 years or over.
- •Type 2 diabetes diagnosis for ≥1 year prior to enrolment.
- •Type 2 diabetes treated with a basal insulin injection regimen and SGLT2 inhibitor and/or GLP-
- •Screening HbA1c ≥59 mmol/mol to ≤97 mmol/mol (≥7.5% and ≤11.0%, inclusive).
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.
- •A female participant who is pregnant.
- •A breastfeeding female participant.
- •Bariatric surgical procedure within the past 12 months or is planning/scheduled for bariatric surgery within the study duration.
研究组 & 干预措施
Standard of care (control)
Self monitoring of blood glucose
干预措施: Self monitoring of blood glucose (Device)
FreeStyle Libre system
FreeStyle Libre 3 continuous glucose monitoring system
干预措施: FreeStyle Libre 3 Continuous Glucose Monitoring System. (Device)
结局指标
主要结局
HbA1c
时间窗: 16 weeks
Difference between treatment groups in mean change from baseline in HbA1c.
次要结局
- HbA1c(32 weeks)
- Time in range (TIR)(32 weeks)
- Time above range (TAR)(32 weeks)
- Time below range(TBR)(32 weeks)
- Frequency of hypoglycaemia events(32 weeks)