FLASH.V: Flash Glucose Monitoring and Surgery in the Hepatopancreaticobiliary (HPB) Surgery and Liver Transplant Population - Verification Study

Not Applicable

• Conditions: iver Transplantation; Anaesthetics; Liver Transplantation; Surgery - Other surgery; Anaesthesiology - Other anaesthesiology; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12619000470190
• Lead Sponsor: niversity of Melbourne: Department of Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-21
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients scheduled to undergo major HPB surgery, liver transplantation or major general surgery at the Austin hospital within the study timeframe

Exclusion Criteria

Patients deemed unfit for surgery
Pregnancy
Patients unable to give informed consent
Patient < 18 years
Patients with known severe adhesive allergies

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Precision of the flash glucose monitoring device relative to the control device for measurements taken during the intra-operative period. <br><br>Precision will be measured via clinical and numerical accuracy of the device compared with the control measurements. Numerical accuracy will be determined using a variety of methods including: mean and median absolute relative difference (ARD), Repeated Bland-Altman analysis etc. Clinical accuracy for blood glucose monitoring is often assessed using Clarke or consensus error grid (CEG) analysis where numerical error is assigned different levels of clinical risk. [Measured at completion of operating time]