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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

Tracking Information
First Submitted Date August 22, 2023
First Posted Date August 25, 2023
Last Update Posted Date April 17, 2024
Actual Study Start Date May 15, 2021
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2023)		 Rate of NODAT [ Time Frame: 6 months after kidney transplantation ]
rate of new onset diabetes after transplantation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Continuous Glucose Monitoring in Peri-operative Period in Kidney Transplant Recipients
Official Title Prospective Observational Study for Efficacy of Perioperative Serum Glucose Level Evaluated by Continuous Glucose Monitoring System in Kidney Transplantation Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Kidney transplant patients
Condition New Onset Diabetes After Transplantation
Intervention Diagnostic Test: continuous glucose monitoring
FreeStyle Libre Flash Glucose Monitoring System
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 22, 2023)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2024
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Jiyoung Sin, MD 82-10-6593-6503 taddy11119@gmail.com
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT06012799
Other Study ID Numbers SNUH-CGM-KT-V1.2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Seoul National University Hospital
Original Responsible Party Same as current
Current Study Sponsor Seoul National University Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Seoul National University Hospital
Verification Date August 2023