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Continuous Glucose Monitoring in Peri-operative Period in Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06012799
Recruitment Status : Recruiting
First Posted : August 25, 2023
Last Update Posted : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
New Onset Diabetes After Transplantation Diagnostic Test: continuous glucose monitoring

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study for Efficacy of Perioperative Serum Glucose Level Evaluated by Continuous Glucose Monitoring System in Kidney Transplantation Patients
Actual Study Start Date : May 15, 2021
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: continuous glucose monitoring
    FreeStyle Libre Flash Glucose Monitoring System

Outcome Measures
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Primary Outcome Measures :
  1. Rate of NODAT [ Time Frame: 6 months after kidney transplantation ]
    rate of new onset diabetes after transplantation


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Kidney transplant patients
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • multi-organ transplant
  • history of previous kidney transplant
  • less than 18 years old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06012799


Contacts
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Contact: Jiyoung Sin, MD 82-10-6593-6503 taddy11119@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Sang-Il Min, MD    82-2-2072-2330    surgeonmsi@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT06012799    
Other Study ID Numbers: SNUH-CGM-KT-V1.2
First Posted: August 25, 2023    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes