CGM Boosted by Artificial Intelligence for Better Glycaemic Control in T2 Diabetes: a Real-life Multicentre Observational Study in Belgium.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Evolution of TIR (glucose 70-180 mg/dl) over a 12-month period after initiation of CGM in patients with T2D treated with MDI regimens.
研究概览
简要总结
Title: CGM Boosted by Artificial Intelligence for better glycaemic control in T2 Diabetes : a real-life multicenter observational study in Belgium - MAGIC-T2D
Background: In Belgium, since May 2023, reimbursement for continuous glucose monitoring systems has been extended to people with type 2 diabetes taking multiple injections of insulin. Despite the results of previous studies, the impact of this technology in terms of glycaemic control and patient-reported outcomes (PROMs) in real life for patients with type 2 diabetes is still unclear.
Objective: To evaluate the impact of the CGMs on glycemic control and PROMs in people living with type 2 diabetes under real-life conditions.
Methods and analysis: In a multicenter real-world observational study, more than 440 people with type 2 diabetes under multiple daily injection therapy who start to be monitored by a CGM in one of the 13 participating Belgian centers, will be followed for a period of 24 months.
Outcomes: The primary and secondary endpoint are respectively the evolution of time spent in range (defined as a sensor glucose value between 70 and 180 mg/dL) and HbA1c from before start to 12 months after start of the CGM.
Exploratory objectives will be studied using artificial intelligence (AI) to study glucose profiles to characterize the heterogeneity of type 2 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Type 2 diabetes on MDI and starting CGM
排除标准
- •Treatment that raises blood sugar levels (corticosteroids, etc.)
- •Secondary and type 1 diabetes
- •Patient not able to sign the Informed Consent
结局指标
主要结局
Evolution of TIR (glucose 70-180 mg/dl) over a 12-month period after initiation of CGM in patients with T2D treated with MDI regimens.
时间窗: From registration to end of 1-year follow-up
次要结局
- Evolution of Hba1c over a 12-month period after initiation of CGM(From registration to end of 1-year follow-up)