Actively Recruiting

Age: 18Years +
All Genders
ID06675903

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent obtained before CGM application
  • Male or female; age: 18 years
  • Kidney transplantation
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Monitoring

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

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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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