Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05352230 · ClinicalTrials.gov registry record · NA
Continuous Glucose Monitoring (CGM) in Kidney-Transplanted Adults
A NA study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT05352230 is a NA study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 4 participants.
The verdict
NCT05352230, a NA study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
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
Interventions
- DEVICE Free style libre-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-04-15 |
| Est. Completion | 2024-05-20 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05352230
The ClinicalTrials.gov registry entry for NCT05352230 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Free style libre-2 is the first listed.
NCT05352230 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05352230 about?
NCT05352230 is a clinical study titled "Continuous Glucose Monitoring (CGM) in Kidney-Transplanted Adults". 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 risk...
What is the current status of trial NCT05352230?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2023-04-15. Estimated completion is 2024-05-20.
What interventions are being tested in trial NCT05352230?
The interventions under investigation include: Free style libre-2 (DEVICE).
Who is sponsoring clinical trial NCT05352230?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.