Effect of Introduction of FreeStyle Libre Monitoring on Glycaemic Control in People with Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of participants with a change in HbA1c of 5.5 mmol/mol or more
研究概览
简要总结
The goal of this clinical trial is to learn if blood sugar monitoring using a FreeStyle Libre device can improve overall Diabetes control in people with Type 2 Diabetes.
The main questions it aims to answer are:
- What is the effect of monitoring using the FreeStyle Libre device for a period of 12 weeks on the blood sugar control of people with Type 2 Diabetes?
- Can monitoring using the FreeStyle Libre device improve the quality of life of people with Type 2 diabetes?
Participants will be asked to wear one of two brands of FreeStyle Libre devices. In one group, participants will have 3 visits, while those in the second group, they will have 4 visits.
Researchers will compare the improvement in the sugar control for the individuals but also compare between the 2 groups.
详细描述
This is a prospective, randomised, open-labelled, non-CTIMP, pilot study. Participants meeting the inclusion criteria and who have consented to participate in the study will be randomised on a 1:1 ratio to receive either Libre 2 or Libre pro iQ. Randomisation will be carried out using an online randomisation tool to allocate a participant to a treatment group.
The study will consist of three visits (Libre 2 arm) and four visits (Libre pro iQ arm). The study will be completed over 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Males and females living with type 2 diabetes mellitus (T2DM) who are aged ≥ 18 and ≤ 75 years
- •On one or more non-insulin glucose lowering agent(s)
- •HbA1c ≥ 69 mmol/mol
- •Able to provide written informed consent
排除标准
- •Participants with a life expectancy of less than 1 year
- •Participants with cognitive dysfunction or neurological disorder, which will interfere with regular, flash glucose monitoring
- •Participants with chronic kidney disease (CKD) with eGFR < 45ml/min/1.73m2 or decompensated liver disease or decompensated congestive cardiac failure
- •Myocardial infarction in the preceding 3 months or if percutaneous coronary intervention planned in the next 6 months
- •Participants on supra-physiological doses of steroids, for example, Prednisolone for the treatment of Rheumatoid arthritis
- •Participants on active dialysis or planned for dialysis treatment during the study
- •Currently participating in another device or drug study that could affect glucose measurements or management
- •Women who are pregnant, breastfeeding or planning to become pregnant. Women should use a reliable form of contraception throughout the study
- •Participants who are already using continuous glucose monitoring (CGM)
- •Participants who have pacemakers, implanted cardioverter defibrillator devices or neurostimulators
- •Participants with an allergy to medical grade adhesive
- •A blood transfusion in the preceding 3 months or a planned blood transfusion during the course of the study
结局指标
主要结局
Number of participants with a change in HbA1c of 5.5 mmol/mol or more
时间窗: 12 weeks
The number of participants with a change in HbA1c of 5.5 mmol/mol or more at the end of the study compared to baseline HbA1c
次要结局
- Change in the Diabetes Quality of Life (DQOL) score(12 weeks)
研究者
Thozhukat Sathyapalan
Professor
University of Hull