NCT06012799

Brief Summary

his study aims to utilize Continuous Glucose Monitoring (CGM) to observe glucose fluctuations in kidney transplant recipients and predict New-Onset Diabetes After Transplantation (NODAT) based on these patterns. Additionally, it seeks to investigate glucose variability resulting from medications and surgeries such as immunosuppressants and steroid regimens post-kidney transplantation. This prospective observational study anticipates identifying factors influencing blood glucose levels and contributing to future research on blood glucose management using CGM monitoring in kidney transplant patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

April 17, 2024

Status Verified

August 1, 2023

Enrollment Period

3.4 years

First QC Date

August 22, 2023

Last Update Submit

April 15, 2024

Conditions

New Onset Diabetes After Transplantation

Outcome Measures

Primary Outcomes (1)

  • Rate of NODAT

    rate of new onset diabetes after transplantation

    6 months after kidney transplantation

Interventions

continuous glucose monitoringDIAGNOSTIC_TEST

FreeStyle Libre Flash Glucose Monitoring System

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney transplant patients

You may qualify if:

  • The study will target 100 kidney transplant patients who have provided consent, among those who underwent the procedure at Seoul National University Hospital after March 2021.

You may not qualify if:

  • multi-organ transplant
  • history of previous kidney transplant
  • less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicInvestigative Techniques

Central Study Contacts

Jiyoung Sin, MD

CONTACT

82-10-6593-6503taddy11119@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 25, 2023

Study Start

May 15, 2021

Primary Completion

September 30, 2024

Study Completion

December 30, 2024

Last Updated

April 17, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)