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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: Clinical Trial NA study, sponsored by University of Alabama at Birmingham.
NCT05352230 is a NA study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine the feasibility and acceptance of CGM in adults with diabetes who underwent kidney transplantation compared to those who use glucometers.
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 |
Why NCT05352230 stopped before completion
NCT05352230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Free style libre-2 is the first listed.
NCT05352230 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05352230's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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