Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery (GluPop)

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Prediabetes; Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT03935919

GluPop

Details and patient eligibility

About

The purpose of this study it to assess whether the continuous glucose monitor system Dexcom G6® can be reliably used for perioperative glucose monitoring in 20 prediabetic or diabetic patients undergoing abdominal surgery in terms of data continuity, accuracy and patient tolerability.

Full description

The current recommended method for monitoring glucose control is bedside point of care capillary blood glucose testing. A significant limitation for this method is the frequency by which blood glucose testing is typically performed, at most 4-6 times daily. Continuous glucose monitoring (CGM) provides an alternative approach to measure glucose values with the advantage of greater frequency of monitoring as it is measured every few minutes.

Whilst CGM use in the outpatient setting is rising and has demonstrated benefits on glycaemic control, the accuracy of these devices perioperatively is less investigated. In this study the sixth-generation factory-calibrated real-time Dexcom G6® system will be used as a CGM and its glucose values perioperatively will be compared to the capillary glucose values which will be measured simultaneously by the Accu-Check Inform II (Roche Diagnostics) point-of-care blood glucose meter.

The Investigators aim to assess the feasibility and accuracy of perioperative CGM.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged ≥18 years
• Pre-diabetic (HbA1c 5.7-6.5%) or diabetic (regardless of aetiology)
• Scheduled to have elective abdominal surgery at the University Hospital Bern
• Surgery duration >2 hours

Exclusion criteria

• Planned MRI procedure during hospitalization
• Inability to follow procedures
• Incapacity to give informed consent
• Presence of extensive skin abnormalities at the sensor insertion site (upper arm)
• Known allergic/irritative skin reactions to dressings/adhesives
• Haematocrit values outside the normal range
• Patients with immunosuppression defined as neutrophil count <0.5x10^9/L
• Patients on isolation precautions (contact, droplet, airborne)
• Pregnancy or breast-feeding