Perioperative Continuous Glucose Monitoring in Patients Undergoing an Abdominal Surgery

NCT ID: NCT03935919

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2020-03-01

Brief Summary

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.

Detailed 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.

Conditions

Diabetes Mellitus; Prediabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lia Bally, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Inselspital, University Hospital of Bern, University of Bern

Locations

Department of Diabetes, Endocrinology, Clinical Nutrition and Metabolism, Inselspital, Bern University Hospital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

GluPop

Identifier Type: -

Identifier Source: org_study_id