Predictive Factors of Steroid-Induced Diabetes and the Role of Continuous Glucose Monitoring in the Diagnosis and Metabolic Control of the Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Diagnosis of diabetes
研究概览
简要总结
Glucocorticoids are widely used in the management of autoimmune, inflammatory and neoplastic conditions. However, they are associated with significant metabolic effects, including steroid-induced diabetes (SID). SID is typically diagnosed using general criteria for type 2 diabetes, which may be inadequate due to the unique glycemic profile often seen in SID, where postprandial hyperglycemia predominates. This research aims to explore the diagnostic value of CGM during steroid therapy and identify risk factors for SID This is a prospective observational study (n=250) enrolling adults initiating glucocorticoid therapy. Participants will undergo 14-day continuous glucose monitoring (CGM) to assess predictive factors and glycemic profile.
详细描述
Approximately 250 patients hospitalised at Warsaw University Hospital will be enrolled. Baseline data collection includes medical history, anthropometry, HbA1c, and basic biochemical tests. CGM sensors will be applied. The glycemic profile will be monitored for 14 days using the CGM system. If time spent above 140 mg/dL exceeds 10%, capillary glucose testing will be used to confirm diabetes based on established clinical guidelines
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Diagnosis of diabetes
时间窗: From enrollment to the end of the observation at 2 weeks
diagnosis of steroid-induced diabetes based on fasting blood glucose 2 times above 126 mg/dl and/or HbA1c\>6.5% and/or blood glucose above 200 mg/dl
次要结局
- Glycemic Target(From enrollment to the end of the observation at 2 weeks)
- Time above 140 mg/dL for ≥10% of the day(From enrollment to the end of the observation at 2 weeks)
- Hypoglycaemia Episodes(From enrollment to the end of the observation at 2 weeks)
- Glycemic profile(From enrollment to the end of the observation at 2 weeks)
研究者
Aleksandra Jedrasek
Principal Investigator
Medical University of Warsaw