The Effect of Continuous Glucose Monitoring With Real-time Alerts on Glycaemic Control in Surgical Patients With Diabetes: A Randomised, Clinical Multicentre Trial
概览
- 阶段
- 4 期
- 干预措施
- Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
- 疾病 / 适应症
- Diabetes Mellitus
- 发起方
- Christian S. Meyhoff
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Time in range (TIR) of CGM glucose levels
- 状态
- 已完成
- 最后更新
- 昨天
概览
简要总结
The goal of this randomised controlled trial to investigate the effect of continuous glucose monitoring (CGM) compared to standard point-of-care (POC) blood glucose measurements in surgical patients with diabetes in patients.
The main question it aims to answer is:
• Can the use of the CGM device Dexcom G7 with real-time alerts on dysglycaemia increase the time in range for glucose levels as compared with standard monitoring with point-of-care blood glucose in surgical patients with diabetes?
Participants will be asked to wear a CGM device (Dexcom G7, Dexcom Inc.) during their stay in the hospital. For patients in the intervention group, deviations of glucose levels will provide the nursing staff with alerts. All patients will receive standard care of their diabetes. The CGM device will be worn for up to 10 days or until discharge.
详细描述
This is a prospective randomised controlled multicentre trial on patients living with diabetes who undergo surgery at Rigshospitalet, Copenhagen University, Bispebjerg and Frederiksberg Hospital, Copenhagen University, and Zealand University Hospital, Køge, Denmark The study aims to investigate the effect of the CGM-device Dexcom G7 CGM in patients with diabetes undergoing surgery on the diabetic control. The Dexcom G7 provides glucose readings every 5 minutes and can send alerts on dysglycaemia (hypo- and hyperglycaemia) to mobile devices held by the nursing staff. Patients will wear the CGM before, during and up to 10 days postoperatively. The study will include 200 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.
研究者
Christian S. Meyhoff
Professor, head of research, MD, PhD
University Hospital Bispebjerg and Frederiksberg
入排标准
入选标准
- •Medical history with diabetes mellitus (DM1 or DM2 (insulin-dependent and non-insulin-dependent) requiring antidiabetic drug(s)
- •Acute or elective abdominal, orthopaedic, urological, or vascular surgery with estimated duration of surgery \>45 minutes
- •Expected stay for at least one night in the hospital postoperatively
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
- •Known allergy to the equipment plaster
- •Known pregnancy
- •Patients with pacemaker or implantable cardioverter defibrillator (ICD) device
- •Previous or currently scheduled for pancreatectomy (complete or partial)
- •Patients receiving hydroxyurea (these drugs may interfere with CGM readings)
研究组 & 干预措施
Intervention group
Participants in the intervention group will wear the CGM-device Dexcom G7, and real-time alerts on dysglycaemia and rapidly increasing or falling glucose levels will alert the nursing staff.
干预措施: Dexcom G7 Continuous Glucose Monitoring (CGM) System (G7)
Control group
Participants in the control group will wear a blinded CGM device. The nursing staff will monitor glucose levels with standard care using POC blood glucose measurements.
结局指标
主要结局
Time in range (TIR) of CGM glucose levels
时间窗: Perioperatively
Time in range (TIR) of CGM glucose levels (6.0-10.0 mmol/l) in minutes per 24 hours after discharge from the post-anaesthesia care unit (PACU) until 10 days postoperative (or until discharge)
次要结局
- Duration of hypoglycaemia(Perioperatively)
- Number of hyperglycaemia events(Perioperatively)
- Number of hypoglycaemia events(Perioperatively)
- Complications(30 days postoperatively)
- Duration of hyperglycaemia(Perioperatively)