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

Post transplant diabetes mellitus Lung transplantation

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

Inclusion Criteria5

All heart and lung transplant recipients meeting the following criteria will be included:
a) Age greater or equal to 18 years
b) HbA1c less than 6.5% (if performed)
c) Fasting glucose less than 7.0 mmol/L (if performed)
d) Willingness to participate and comply with the study

Exclusion Criteria3

Patients who will be excluded from participation:
a) Those with an established diagnosis of diabetes
b) Those prescribed glucose lowering medications such as metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors and insulin.

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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 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.