Continuous Glucose Monitoring in Peri-operative Period in Kidney Transplant Recipients
Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06012799
Collaborator
(none)
100
1
31.5
3.2
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated 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
Anticipated Primary Completion Date
:
Sep 30, 2023
Anticipated Study Completion Date
:
Dec 30, 2023
Outcome Measures
Primary Outcome Measures
- Rate of NODAT [6 months after kidney transplantation]
rate of new onset diabetes after transplantation
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
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
Exclusion Criteria:
-
multi-organ transplant
-
history of previous kidney transplant
-
less than 18 years old
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT06012799
Other Study ID Numbers:
- SNUH-CGM-KT-V1.2
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes