Validation of the Accuracy of Continuous Glucose Monitoring Using the Dexcom G7 in Patients With Diabetes in Situations With Circulatory Impairment. A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Agreement between glucose
研究概览
简要总结
The goal of this observational study is to investigate the accuracy of the continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in patients with diabetes in patients who during their hospital admission can experience circulatory impairment.
The main questions it aims to answer are:
• Do CGM measurements have a decreased accuracy compared to standard blood glucose measurements in periods with circulatory impairment?
Participants will be asked to wear a blinded CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital but will receive standard care of their diabetes. The CGM device will be worn for up to 10 days.
详细描述
This is a prospective observational study on patients living with diabetes who a) undergo surgery at the Department of Vascular Surgery, Rigshospitalet, Denmark and the Surgical Department and Department of Orthopedic Surgery and Traumatology, Bispebjerg and Frederiksberg Hospital, Denmark, or b) are admitted to the intensive care unit (ICU) at Bispebjerg and Frederiksberg Hospital with circulatory impairment.
The study aim is to investigate the accuracy of the Dexcom G7 CGM in patients with diabetes undergoing surgery and in patients at the ICU with circulatory impairment. The glucose readings will be compared to standard practice with POC blood glucose measurements.
Included patients will be asked to wear the CGM device Dexcom G7 for up 10 days.
The study will include 60 patients
This study is part of an overall project that aims to investigate the use of CGM and continuous wireless monitoring of vital signs in patients with diabetes undergoing major surgery. Using this technology, postoperative complications including dysglycaemia can potentially be detected and treated earlier thus improving the perioperative care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Medical history with diabetes mellitus requiring antidiabetic drugs
- •Age ≥18 years
- •Surgery with estimated surgery time ≥45 minutes with expected stay for at least one night in hospital postoperatively OR
- •Admission to the ICU with Circulatory impairment defined as need of vasopressors to maintain a mean arterial pressure (MAP) ≥65 mmHg and peripheral perfusion index <1.5
排除标准
- •Local skin symptoms including infection at the posterior aspect of the upper arm that does not allow the sensor to be placed on an unaffected skin area
- •Contraindications to skin puncture (arteriovenous fistula for dialysis, post-mastectomy lymphoedema etc)
- •Known allergy to plaster used in the CGM device
结局指标
主要结局
Agreement between glucose
时间窗: Perioperatively
Agreement between glucose readings in mmol/L recorded by the CGM device Dexcom G7 and point-of-care blood glucose measurements (matched pairs within 5 minutes) in the perioperative setting
次要结局
- Agreement between glucose readings when at low glucose levels(Perioperatively)
- Agreement between glucose readings when at normal glucose levels(Perioperatively)
- Agreement between glucose readings when at high glucose levels(Perioperatively)
研究者
Casper Pedersen
MD, principal investigator
University Hospital Bispebjerg and Frederiksberg