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

A prospective observational study to determine the clinical and numerical precision of intermittent continuous glucose monitoring in the perioperative period in hepatopancreaticobiliary surgery and orthotopic liver transplant patients.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000470190
Acronym
FLASH.V
Enrollment
100
Registered
2019-03-21
Start date
2019-04-01
Completion date
2020-04-01
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine how well flash glucose monitoring performs in patients during the periods before, during and after surgery, in patient who are undergoing major general surgery with a focus on pancreatic surgery, surgery on the bile duct system and surgery on the liver and liver transplantation. It will compare the results of the flash glucose monitoring with arterial blood glucose and capillary blood glucose levels

Interventions

This is an observational study which will look at the precision of a flash glucose monitoring sensor when patients are undergoing surgery. Each participant will have a flash glucose monitoring sensor applied to the upper left arm. The sensor is applied using the sensor applicator that is supplied with the sensor, in a sterile pack. A thin flexible sterile fibre (5mm long) is inserted just below the skin. Most patients reported that applying the sensor was painless. "In a 2013 US study conducte

This is an observational study which will look at the precision of a flash glucose monitoring sensor when patients are undergoing surgery. Each participant will have a flash glucose monitoring sensor applied to the upper left arm. The sensor is applied using the sensor applicator that is supplied with the sensor, in a sterile pack. A thin flexible sterile fibre (5mm long) is inserted just below the skin. Most patients reported that applying the sensor was painless. "In a 2013 US study conducted by Abbott Diabetes Care, 100% of the patients surveyed (n=30) rated that applying the sensor was painless or almost painless, and 93.4% of patients strongly agree or agree that while wearing the sensor, they did not feel any discomfort under their skin." (https://www.freestylelibre.com.au/) The sensor takes near continuous readings of the patients blood glucose levels. This will be compared at regular time points with standard of care blood glucose readings, thus each participant's standard of care blood glucose measurement will be the control. Participants will be followed from surgery check in time to the first occurring end point from: 14 days post-operation

Sponsors

University of Melbourne: Department of Surgery
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026