跳至主要内容
临床试验/NCT07583238
NCT07583238尚未招募不适用

Assessing the Impact of Intraoperative Diathermy on Accuracy and Functioning of Glucose Monitoring Systems

University of Nottingham1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
126
试验地点
1

研究概览

简要总结

The goal of this observational study is to investigate if diathermy (a surgical tool that uses electrical energy to control bleeding) has any affect on the accuracy and functioning of continuous glucose monitoring systems in adults and young people with Type 1 Diabetes. The main questions this study aims to answer is -

- Does the accuracy of continuous glucose monitoring systems change after use of diathermy?

Participants will:

  • Have their height and weight checked.
  • Provide information about their medical history including type of diabetes, other medical conditions and any current medications they take.
  • Have paired glucose meter and sensor glucose measurements taken every 15-75 minutes from up to 4 hours before surgery until up to 4 hours after the end of surgery.
  • Have two blood samples taken to measure glucose levels, The first one will be before the use of diathermy and the second will be after the use of diathermy.

详细描述

Background and rationale:

The incidence of type 1 diabetes is rising and technology is an increasingly important part of monitoring and responding to glucose levels. Contemporary monitoring of glucose levels using continuous glucose monitoring (CGM) systems provide users with information about their glucose levels in real time without finger-prick capillary glucose testing. Crucially, these new systems provide information about the trend in blood glucose levels and is now standard in type 1 diabetes. Use of CGM systems is also needed for patients who use "closed loop" systems which adjust insulin at, typically, 5-minute intervals in response to glucose levels. Use of these strategies in glucose level monitoring and management improves long-term outcomes for persons living with diabetes and is now standard of care in type 1 diabetes. Their importance during inpatient admissions and surgery is increasingly recognised but data is limited.

During surgery, diathermy is often used to control bleeding by using high-frequency electrical energy to seal small blood vessels. Available literature supports the hypothesis that CGM systems may not be affected by diathermy, but there is limited information on the actual impact of diathermy on the accuracy of CGM systems. At present, CGM systems warranties are invalidated by diathermy use. Consequently, patients undergoing surgery require a period of blood glucose testing to monitor and respond to glucose levels which are often rendered unstable in the period around surgery. This exposes patients to potentially unnecessary interventions and, for those patients who are needle-phobic or have learning difficulties, the need to renew repeated finger-prick capillary blood testing around surgery may be a significant barrier to effective and optimal glucose monitoring and control. In addition, there may be a delay in responding to hypoglycaemia and hyperglycaemia, due to the time between measurements.

This study aims to assess the impact of intraoperative diathermy use on the accuracy and functioning of CGM systems. Demonstrating that glucose monitoring systems could be effectively used during surgery would:

  • Prevent/reduce the need for the anaesthetic team to access the patients' fingers/toes and venous/arterial lines for blood glucose testing during surgery.
  • Provide easy, convenient and accurate glucose monitoring to the anaesthetic team, with data transmitted from monitoring systems which can remain underneath surgical coverings.
  • Provide prompt, real-time information on glucose trends during surgery, leading to better control of glucose levels including earlier recognition of low and high glucose levels (hypoglycaemia and hyperglycaemia, respectively).

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
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of type 1 diabetes mellitus.
  • Planned admission for elective surgery at Nottingham University Hospitals NHS Trust.
  • Currently routinely using a prescribed Abbott Libre-2, Abbott Libre-3, Dexcom G6 or Dexcom G7 glucose monitoring system to monitor glucose concentrations.
  • Aged 4 years or older on the day of surgery.
  • Ability to give informed consent / ability of parent/carer to give informed consent (as appropriate).

排除标准

  • Use of paracetamol above maximum dose within 7 days before the scheduled date of surgery (in adults with body weight under 51kg - maximum of 60mg/kg per day, in adults with body weight 51kg and above - maximum of 4g per day, in children - maximum dose as per their age as stated in the British National Formulary for Children)
  • Any use of hydroxyurea within 7 days before the scheduled date of surgery
  • Use of more than 500mg per day of ascorbic acid / vitamin C within 7 days before the scheduled date of surgery
  • Currently taking medications as part of a clinical trial.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验