RecruitingACTRN12625000209493

A study testing whether use of a commercially available continuous glucose monitoring device is as effective as traditional blood tests for diagnosis of diabetes in heart or lung transplant recipients thought to be free from diabetes at least 1-year after transplant surgery.

Continuous glucose monitoring as a non-invasive, cost-effective method to simplify and enhance diagnosis of diabetes in patients thought to be free from diabetes at least 1-year after heart and/or lung transplantation


Sponsor

St Vincent's Hospital Sydney

Enrollment

100 participants

Start Date

Jun 1, 2025

Study Type

Interventional

Conditions

Summary

Hyperglycaemia and post-transplant diabetes mellitus (PTDM) are common in heart and lung transplant recipients. PTDM has been associated with unfavorable transplant-related outcomes including increased rates of infection, rejection, graft dysfunction and mortality. To prevent unnecessary transplant-related morbidity and mortality, accurate and sensitive screening tests are required to optimize the diagnosis of PTDM in heart and lung transplant recipients. The proposed study will examine whether use of a simple and inexpensive CGM (FreeStyle Libre2) is non-inferior to the more cumbersome 75-gram OGTT to diagnose PTDM in transplant recipients without a known diagnosis of diabetes at least 12 months after heart or lung transplantation.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After a heart or lung transplant, many patients develop post-transplant diabetes mellitus (PTDM) — a form of diabetes caused by the medications needed to prevent organ rejection. PTDM can increase the risk of infections, rejection, and other complications, so detecting it early is important. The current gold-standard test — a glucose tolerance test (OGTT) — requires fasting, a special sugary drink, and multiple blood draws over two hours, which can be burdensome. This study is testing whether a continuous glucose monitoring (CGM) patch called FreeStyle Libre2 — worn on the upper arm for up to two weeks and read with a smartphone scan — can diagnose PTDM as reliably as the OGTT. If it can, this simple wearable device could replace the more inconvenient blood test. You may be eligible if you have had a heart or lung transplant at least 12 months ago and do not have a known diabetes diagnosis. Your HbA1c and fasting glucose must be within normal limits. People already taking diabetes medication are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Study design: A prospective study comparing the effectiveness of a commercially available continuous glucose monitoring system (Freestyle Libre2, Abbott Diagnostics) to gold-standard 75-gram oral gluc

Study design: A prospective study comparing the effectiveness of a commercially available continuous glucose monitoring system (Freestyle Libre2, Abbott Diagnostics) to gold-standard 75-gram oral glucose tolerance test for diagnosis of post-transplant diabetes mellitus (PTDM) in heart and/or lung transplant patients thought to be free from PTDM at least 1-year after heart or lung transplantation. Study participation involves completion of an outpatient 72-hour oral glucose tolerance test (as per professional society recommendations) followed by continuous glucose monitoring via a FreeStyle Libre sensor. The sensor is a minimally invasive device applied during a study visit to the hospital outpatient clinic by a study investigator. The sensor is painless and worn on the back of the non-dominant arm for 2-weeks. Data collected by the sensor is uploaded remotely and shared with study investigators via the LibreView platform. At the end of 2 weeks the participant removes the sensor as per manufacturers instructions and completes a patient experience survey via email link to a secure REDCAP database.


Locations(1)

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12625000209493


Related Trials