A Randomized Study of the Glunovo Real-Time Continuous Glucose Monitoring (CGM) Effectiveness on Metabolic Control in Patients With Type 2 Diabetes (T2D)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- changes in HbA1c levels
研究概览
简要总结
The study aims to evaluate the effectiveness of the novel Real-Time Continuous Glucose Monitoring (RT-CGM) system "Glunovo" in improving glycemic control and patient-reported outcomes in individuals with poorly controlled Type 2 Diabetes (T2D).
详细描述
This is a prospective, open-label, randomized controlled trial involving 165 adult patients with T2D recruited at the Fatebenefratelli-Sacco Hospital in Milan. Participants were randomized in a 1:1 ratio to either the intervention group (RT-CGM with Glunovo) or the control group (standard Self-Monitoring of Blood Glucose [SMBG] using conventional glucometers).
The primary outcome is the change in Glycated Hemoglobin (HbA1c) levels after 6 months of follow-up. Secondary outcomes include Continuous Glucose Monitoring (CGM)-derived metrics-such as Glucose Management Indicator (GMI), Time in Range (TIR), Time Above Range (TAR), and Time Below Range (TBR)-as well as patient well-being, assessed using the WHO-5 Well-Being Index and a satisfaction scale.
The study is designed to assess whether the Glunovo RT-CGM system can support better metabolic control and improve patient experience compared to conventional SMBG methods.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 2 Diabetes (T2D) Age above 18 years Glycated Hemoglobin (HbA1c) between 7.5% and 11% On basal-bolus insulin, basal-oral combination therapy, or non-insulin antidiabetic therapy
排除标准
- •Pregnancy HbA1c > 11% or < 7.5% Diagnosis of Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA), Maturity Onset Diabetes of the Young (MODY), or other forms of hyperglycemia
结局指标
主要结局
changes in HbA1c levels
时间窗: 6 months
The primary outcome of the study was to evaluate changes in HbA1c levels after 6 months of RT-CGM use compared to baseline in both the intervention and control groups
次要结局
未报告次要终点
研究者
Paolo Fiorina, MD
Professor
University of Milan