Continuous Glucose Monitoring in Peri-operative Period in... | NCT06012799

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

NCT06012799

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Apr 17, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

New Onset Diabetes After Transplantation

Interventions

continuous glucose monitoring

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2021Actual

Primary Completion Date

Sep 30, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Aug 22, 2023

First Submission Date that Met QC Criteria

Aug 22, 2023

First Posted Date

Aug 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2024

Last Update Posted Date

Apr 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
continuous glucose monitoring	Diagnostic Test	FreeStyle Libre Flash Glucose Monitoring System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of NODAT	rate of new onset diabetes after transplantation	6 months after kidney transplantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Kidney transplant patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiyoung Sin, MD	Contact	82-10-6593-6503		taddy11119@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000095583	Continuous Glucose Monitoring

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

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Browse Branches

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