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Continuous Glucose Monitoring (CGM) After Kidney Transplantation (CGM-KTx) 54

Recruiting
Clinical Trial NCT06675903 (CGM-KTx) is an observational study for Hyperglycaemia, Kidney Transplantation that is recruiting. It started on 12 November 2024 with plans to enroll 54 participants. Led by Bo Feldt-Rasmussen, it is expected to complete by 1 January 2026. The latest data from ClinicalTrials.gov was last updated on 13 November 2024.
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 particip...

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Detailed Description
Introduction:

Hyperglycaemia is a common medical complication within the first two weeks following kidney transplantation. High doses of prednisone induce a state of insulin resistance, which can cause hyperglycaemia or disrupt glucose regulation in patients with pre-existing diabetes. Current guidelines recommend daily blood glucose monitoring (BGM), defined as four daily glucose measurements during the first four ...

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Official Title

Continuous Glucose Monitoring in Kidney Transplant Recipients with Diabetes, Pre-diabetes and Without Diabetes

Conditions
HyperglycaemiaKidney Transplantation
Other Study IDs
  • CGM-KTx
  • H-24046404
NCT ID Number
NCT06675903
Start Date (Actual)
2024-11-12
Last Update Posted
2024-11-13
Completion Date (Estimated)
2026-01-01
Enrollment (Estimated)
54
Study Type
Observational
Status
Recruiting
Keywords
Kidney transplantation
diabetes
prediabetes
hyperglycaemia
continuous glucose monitoring
CGM
Arms / Interventions
Participant Group/ArmIntervention/Treatment
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
N/A
No diabetes
No diabetes defined as HbA1c \<42mmol/mol or FPG\<6.1 mmol/L
N/A
Prediabetes
Prediabetes group defined as HbA1c 42-47 mmol/mol or FPG 6.1-6.9 mmol/L
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Difference in Mean Sensor Glucose
Mean sensor glucose (mmol/L) evaluated by CGM
10 days
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Time in range (%)
Time within 3.9-10.0 mmol/L as evaluated by CGM
10 days
Compliance with applicable guideline (%)
Based on capillary blood glucose (mmol/L) and daily insulin dose (IE per day)
10 days
Time in hypoglycaemia (%)
Time in level 1 (3.0-3.8 mmol/L) and level 2 (below 3.0 mmol/L\]) evaluated by CGM
10 days
Time in tight glycaemic range (%)
Time in 3.9-7.8 mmol/L evaluated by CGM
10 days
Time i hyperglycaemia (%)
Time in level 1 (10.1-13.9 mmol/L) and level 2 (above 13.9 mmol/L) evaluated by CGM
10 days
Glucose variability
Standard deviation \[mmol/L\] and coefficient of variation \[%\]) evaluated by CGM
10 days
Glucose management indicator (GMI) (mmol/mol and %)
Evaluated by CGM
10 days
Number of hyperglycaemic events (Number/days measured)
Defined as glucose ≥10.0mmol/L for more than 15 minutes measured by CGM
10 days
Number of hypoglycaemic events (Number/days measured)
Defined as glucose \<3.9mmol/L for more than 15 minutes measured by CGM
10 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Written informed consent obtained before CGM application
  • Male or female; age: ≥18 years
  • Kidney transplantation

  • 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
Bo Feldt-Rasmussen logoBo Feldt-Rasmussen
Study Responsible Party
Bo Feldt-Rasmussen, Sponsor-Investigator, Professor, Rigshospitalet, Denmark
Study Central Contact
Contact: Ida S Voss, MD, +4535457063, [email protected]
1 Study Locations in 1 Countries

DK

Rigshospitalet, Copenhagen, DK, 2100, Denmark
Ida S Voss, MD, Contact, +4535457063, [email protected]
Tobias Bomholt, MD, PhD, Contact, +4535457952, [email protected]
Ida S Voss, MD, Contact
Recruiting