Continuous Glucose Monitoring (CGM) After Kidney Transplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBo Feldt-Rasmussen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent obtained before CGM application
Male or female; age: ≥18 years
Kidney transplantation
Disqualifiers
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
Trial population
Adult kidney transplant recipients at Rigshospitalet, Copenhagen, Denmark
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
54 Participants
are grouped into 3 trial groupsGroup A: Diabetes
Group B: No diabetes
Group C: Prediabetes
Trial outcomes
Primary outcomes
1
Difference in Mean Sensor Glucose
Mean sensor glucose (mmol/L) evaluated by CGM
Time frame
10 daysSecondary outcomes
1
Time in range (%)
Time within 3.9-10.0 mmol/L as evaluated by CGM
Time frame
10 days2
Compliance with applicable guideline (%)
Based on capillary blood glucose (mmol/L) and daily insulin dose (IE per day)
Time frame
10 days3
Time in hypoglycaemia (%)
Time in level 1 (3.0-3.8 mmol/L) and level 2 (below 3.0 mmol/L\]) evaluated by CGM
Time frame
10 days4
Time in tight glycaemic range (%)
Time in 3.9-7.8 mmol/L evaluated by CGM
Time frame
10 daysOther outcomes
1
HbA1c
Changes in HbA1c (mmol/mol and %) 10-14 days after kidney transplantation
Time frame
10 days2
Daily dose of immunosuppressant
prednisone, tacrolimus, cyclosporine, mycophenolate mofetil
Time frame
10 days3
HOMA
HOMA calculated from fasting glucose (mmol/L) and fasting plasma insulin (pmol/L) at time of transplantation and 10-14 days after kidney transplantation
Time frame
10 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bo Feldt-Rasmussen
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Source ClinicalTrials.gov