Continuous Glucose Monitoring (CGM) After Kidney Transplantation
CGM-KTx
1 other identifier
observational
54
1 country
1
Brief Summary
This study examines glucose levels measured by continuous glucose monitoring (CGM) in the immediate period following kidney transplantation among recipients with diabetes, without diabetes, and with pre-diabetes. The primary objective is to analyse differences in mean sensor glucose between these three groups. CGMs are applied to participants within 72 hours after kidney transplantation, with a total of 54 participants divided equally across the three groups (18 in each). Secondary objectives include assessing additional glucose profile indices, adherence to relevant guidelines, changes in HbA1c, the impact of immunosuppression and steroid dosage, and beta cell function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2024
CompletedFirst Posted
Study publicly available on registry
November 5, 2024
CompletedStudy Start
First participant enrolled
November 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedNovember 13, 2024
November 1, 2024
1.1 years
October 31, 2024
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Mean Sensor Glucose
Mean sensor glucose (mmol/L) evaluated by CGM
10 days
Secondary Outcomes (9)
Time in range (%)
10 days
Compliance with applicable guideline (%)
10 days
Time in hypoglycaemia (%)
10 days
Time in tight glycaemic range (%)
10 days
Time i hyperglycaemia (%)
10 days
- +4 more secondary outcomes
Other Outcomes (3)
HbA1c
10 days
Daily dose of immunosuppressant
10 days
HOMA
10 days
Study Arms (3)
Diabetes
Diabetes group defined as type 2 diabetes, type 1 diabetes, receiving glucose-lowering therapy, FPG ≥ 7 mmol/l, HbA1c ≥ 48mmol/l or non-fasting plasma glucose ≥11.1 mmol/l
No diabetes
No diabetes defined as HbA1c \<42mmol/mol or FPG\<6.1 mmol/L
Prediabetes
Prediabetes group defined as HbA1c 42-47 mmol/mol or FPG 6.1-6.9 mmol/L
Eligibility Criteria
Adult kidney transplant recipients at Rigshospitalet, Copenhagen, Denmark
You may qualify if:
- Written informed consent obtained before CGM application
- Male or female; age: ≥18 years
- Kidney transplantation
You may not qualify if:
- Unable to cooperate to CGM the first ten days after surgery
- Allergic to plasters in CGM units
- Combined kidney and liver or pancreatic transplantation
- Graft loss/rejection within first 48 hours after transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, DK, 2100, Denmark
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 31, 2024
First Posted
November 5, 2024
Study Start
November 12, 2024
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
November 13, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share