Effects of COntinuous Glucose moNitoring Versus Usual Care on glycEmic Control in Non-insulin-tReated Adults With Type 2 Diabetes：a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sinocare
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- HbA1c
研究概览
简要总结
The clinical value of CGM for diabetic patients undergoing insulin therapy has been widely recognized, but the evidence-based support for its use in non-insulin-treated type 2 diabetic patients remains insufficient. The primary objective of this study is to evaluate the effect of real-time continuous glucose monitoring (CGM) compared with self-monitoring of blood glucose on glycemic control in adults with non-insulin treated type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •(1)Subjects aged ≥18 years at screening (based on the day of signing the informed consent form) and of any gender
- •(2)Patients diagnosed with type 2 diabetes
- •(3)Prior to the screening, glycemic control was suboptimal with diet, exercise control, and oral medication or glucagon-like peptide-1RA (GLP-1RA) therapy maintained for more than 3 months, 7.5%≤HbA1c≤10%
- •(4)Subjects voluntarily sign an informed consent form
排除标准
- •(1)Patients treated with insulin within 3 months prior to screening
- •(2)Currently or have used a CGM device within 3 months prior to enrollment
- •(3)Serious skin disease at the sensor placement site, allergy to tape or adhesives
- •(4)Pregnant females, those with a positive pregnancy test result at screening, or those who plan to become pregnant during the study
- •(5)Those who are participating or will participate in other clinical trials
- •(6)Those who, in the opinion of the investigator, should not participate in this clinical trial, such as: ①those who have a history of eye trauma or other diagnosed eye diseases resulting in visual impairment, etc.; ②those who are unwilling or unable to fully understand or cooperate due to speech disorders; ③those who suffer from mental disorders
研究组 & 干预措施
Real-time Continuous glucose monitor
In the first two weeks of every four-week period, rt-CGM is used to monitor blood glucose levels, while in the latter two weeks, SBMG is employed for usual care
干预措施: Sinocare iCan I3 CGM (Device)
Self-monitoring of blood glucose
Using SMBG for usual care only.
干预措施: Sinocare jinzhi+Blood glucose meter (Device)
结局指标
主要结局
HbA1c
时间窗: 24 weeks
Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to week 24.
HbA1c
时间窗: From enrollment to the end of the 24-week intervention period.
Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to week 24.
次要结局
- HbA1c & CGM(From enrollment to the end of the 24-week intervention period.)