Comparison of continuous v/s conventional blood glucose monitoring in children with diabetic ketoacidosis-A Open label Randomized control Trial-(COCO Glu Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Accuracy of glucose monitoring
研究概览
简要总结
We aim to compare continuous verses conventional blood glucose monitoring in children with diabetetic ketoacidosis an open label randomized trial .There are few studies examining the use of CGM inchildren with DKA in this part of the country . We are evaluating feasibility and acceptabilityof CGM device in paediatric population with DKA While CGM shows promise for enhancingglucose monitoring during paediatric DKA it has not been validated. By futher research we would like to explore avenues in its accuracy,feasibility ,reliability and safety inthis critical setting compared to POCT glucose monitoring methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •All children in age group 5-14 years with moderate to severe DKA admitted to PICU.
排除标准
- •known comorbid diseases(cardiac,,CKD,neurological disease) 2.Presence of haemodynamic instability or multi organ failure 3.known allery or contraindication to GCM sensor 4.subjects who have not given consent.
结局指标
主要结局
Accuracy of glucose monitoring
时间窗: Time in range during DKA management0-6 hours after starting insulin 6-12 hours 12 hours to biochemical resolution target range of 150-200mg/dl
Agreement between CGM values and standard lab venous values
时间窗: Time in range during DKA management0-6 hours after starting insulin 6-12 hours 12 hours to biochemical resolution target range of 150-200mg/dl
次要结局
- detection of hypoglycemia & hyperglycemia(number of blood glucose measurements required)
研究者
Dr Jyothi Naik
Aiims mangalagiri