Actively Recruiting
Continuous Glucose Monitoring in Kidney Transplant Recipients with Diabetes, Pre-diabetes and Without Diabetes
Led by Bo Feldt-Rasmussen · Updated on 2024-11-13
54
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study glucose levels measured by continuous glucose monitoring (CGM) immediately after kidney transplantation in patients with diabetes, prediabetes, and no diabetes. The primary goal is to compare the average glucose levels among these three groups. This study also explores other glucose-related measures, adherence to guidelines, changes in HbA1c, and the effects of immunosuppressive and steroid treatments on beta cell function. Participants will be grouped into diabetes, prediabetes, and no diabetes categories, with 18 people in each group. CGM devices will be applied within 72 hours after kidney transplantation and will monitor glucose levels continuously for 10 to 14 days. Blood samples for HbA1c, C-peptide, and insulin will be collected at the start and end of CGM monitoring. Medical records will be reviewed for medications, complications, and vital signs during CGM use. Physicians will manage glucose levels according to standard guidelines without access to CGM data. During the study, participants will have a CGM sensor measuring glucose multiple times daily for up to two weeks post-transplant. Researchers will assess glucose patterns, including time spent in target glucose ranges and episodes of high or low blood sugar. Outcomes include mean sensor glucose over 10 days and other glucose variability measures. Data will be analyzed to understand glucose differences between groups and factors influencing glucose control. The total participation time involves CGM wear and blood sample collection within the first two weeks after transplantation.
CONDITIONS
Brief Title
Continuous Glucose Monitoring (CGM) After Kidney Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before CGM application
- Male or female; age: 18 years
- Kidney transplantation
You will not qualify if you...
- Unable to cooperate to CGM the first ten days after surgery
- Allergic to plasters in CGM units
- Combined kidney and liver or pancreatic transplantation
- Graft loss/rejection within first 48 hours after transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 10 to 14 days
Participants will have a continuous glucose monitor (CGM) applied within 72 hours after kidney transplantation to measure glucose levels continuously for 10 to 14 days. Additional blood samples will be collected at the start and end of this monitoring period.
1 visit for CGM application and 1 visit for CGM removal (in-person)
Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen, DK, Denmark, 2100
Actively Recruiting
Research Team
I
Ida S Voss, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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