Continuous Glucose Monitoring (CGM) in Kidney-Transplanted Adults

Stopped early · Not applicable

Conditions studied: Diabetes Mellitus, Kidney Transplant; Complications

In brief

Pre-existing diabetes prior KT and Early Post-Transplant Hyperglycemia (PTRH) defined as a fasting blood glucose greater than or equal to 126 mg/dL or random glucose greater than or equal to 200 mg/dL or requirement of insulin during the first 45 days after KT has been associated with increased risks of post-transplant organ rejection. PTRH has also been associated to high infection rates, and in some cases, early mortality. The use of continuous glucose monitoring (CGM) compared with blood glucose meter monitoring in non-transplant patients with diabetes resulted in lower HbA1C by 0.4 to 0.5% within the first three months of use without major changes in patients' antidiabetic regimen, possibly due to patients become more conscious about their diabetes status and diet. CGM free style libre-2 measures the interstitial fluid every minute and their glucose sensors are replaced every two weeks. To our knowledge there are no studies that assess the role of CGM in improving glycemic and transplant outcomes in solid organ transplant patients, mainly because access to CGM is often limited by inadequate health insurance coverage or high out-of-pocket costs. The investigators hypothesize that the intervention will be feasible and acceptable to patients, and our overarching hypothesis is that patients who wear a CGM will have better glycemic control, using a proxy measure of lower fructosamine/albumin ratio and better CGM-parameters, compared to those who did not wear it. Fructosamine represents the average glycemia for the 2 to 3 weeks prior. It is useful in any situation where glycemic control needs to be assessed over a period shorter than a month and in cases involving interference in the HbA1C measurement such as in adults with KT due to shorter red blood cell lifespan related to anemia of chronic disease. Fructosamine values vary in relation to the serum albumin concentration, which makes the fructosamine/albumin ratio the ideal physiologic measure for this pilot study . The investigators also hypothesize that patients who wear a CGM will have less microalbuminuria compared to those who did not wear it.

Key facts

Study ID
NCT05352230
Run by
University of Alabama at Birmingham
People needed
4
Starts
2023-04-15
Expected to finish
2024-05-20
Last updated by the study team
2025-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.