Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 533
- 试验地点
- 1
- 主要终点
- Time in range (3.9~10.0mmol/L, %)
研究概览
简要总结
Current continuous glucose monitoring (CGM) devices provide features that alert for current and impending adverse glycemic events.This trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.
详细描述
Glycemic management for patients with diabetes during hospitalization is highly challenging, especially for those requiring intensive insulin therapy. For those patients, hypoglycemia is a common adverse event, which is associated with adverse clinical outcomes. Bedside capillary point-of-care (POC) glucose monitoring is the standard of care to assess glycemic control in the hospital. However, POC glucose testing only provides glucose measurements at specific time points, leading to missed information important for glycemic control. Continuous glucose monitoring (CGM) measures interstitial glucose every 5 min, thus providing a more complete glycemic profile during a 24 h period compared with standard POC glucose testing.
The cloud-based real-time continuous glucose monitoring (RT-CGM) and management system was previously observed to be safe and effective in guiding intensive insulin therapy. Therefore, this CGM intergraded system holds promise for improving glucose control in patients with diabetes during hospitalization. However, it is currently unclear if alerts are the main reason for the better outcome in the RT-CGM groups, or rather the fact that sensor values are available in real-time. Moreover, the current system provided the feature of predictive threshold alerts that could alert before the onset of clinical hypoglycemia or hyperglycemia. Thus, this trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Males and females ≥ 18 years.
- •Type 1 or type 2 diabetes with suboptimal glucose control requiring hospitalization, as determined by endocrinologists following clinical guidelines.
- •Willingness and ability to comply with the clinical investigation plan.
排除标准
- •significant hyperglycemia or diabetic ketoacidosis requiring continuous intravenous insulin infusion.
- •Female subjects who are pregnant or have a plan of pregnancy at time of enrollment into the study.
- •Current users of real-time glucose monitoring sensors or flash-glucose monitoring.
- •Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
- •Patients expected to require operation, admission to the ICU and MRI procedures during hospitalization.
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
结局指标
主要结局
Time in range (3.9~10.0mmol/L, %)
时间窗: Through study completion (during hospitalization, 5-7 days)
Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.
次要结局
- Coefficient of variation (CV)(Through study completion (during hospitalization, 5-7 days))
- Glycemia risk index (GRI)(Through study completion (during hospitalization, 5-7 days))
- Time below range (<3.0mmol/L, %)(Through study completion (during hospitalization, 5-7 days))
- Standard deviation (SD)(Through study completion (during hospitalization, 5-7 days))
- Time above range (>10.0mmol/L, %)(Through study completion (during hospitalization, 5-7 days))
- Time in range (3.9~7.8mmol/L, %)(Through study completion (during hospitalization, 5-7 days))
- Mean sensor glucose (MSG)(Through study completion (during hospitalization, 5-7 days))
- Time above range (>13.9mmol/L, %)(Through study completion (during hospitalization, 5-7 days))
- Time below range (<3.9mmol/L, %)(Through study completion (during hospitalization, 5-7 days))
研究者
Jian Zhou
Principal Investigator, Professor, Chief Physician, Deputy Director
Shanghai 6th People's Hospital