HyperglycaemiaCGM-KTxNCT06675903
Continuous Glucose Monitoring (CGM) After Kidney Transplantation
An observational study of Hyperglycaemia and Kidney Transplantation, run by Bo Feldt-Rasmussen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycaemia, Kidney Transplantation
- How many people
- 54 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult kidney transplant recipients at Rigshospitalet, Copenhagen, Denmark
Who may be able to join
- Written informed consent obtained before CGM application
- Male or female; age: ≥18 years
- Kidney transplantation
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, DK, 2100
Ida S Voss, MD, +4535457063, ida.voss@regionh.dk
Tobias Bomholt, MD, PhD, +4535457952, Tobias.bomholt@regionh.dk
About this study
Official title: Continuous Glucose Monitoring in Kidney Transplant Recipients With Diabetes, Pre-diabetes and Without Diabetes
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.
Read the 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 days post-transplant, with insulin administered to maintain stable glucose levels. Minor studies using continuous glucose monitoring (CGM) suggest that patients, particularly those with diabetes, are prone to dysregulation. Early and optimised treatment of post-surgical hyperglycaemia may reduce the risk of later post-transplant diabetes mellitus (PTDM) and associated cardiovascular mortality and loss of graft function.
Objectives:
This study aims to investigate differences in glucose profiles during the initial two weeks following kidney transplantation among patients with diabetes, prediabetes, and no diabetes. We hypothesise that patients with pre-existing diabetes will exhibit the highest glucose levels, despite insulin treatment.
Background:
Patients with end-stage kidney disease require kidney replacement therapy, provided through haemodialysis, peritoneal dialysis, or kidney transplantation. Kidney transplantation is generally considered the best option in terms of quality of life and cost-effectiveness. However, kidney transplant recipients require complex immunosuppressive regimens and present an increased susceptibility to infection, malignancy, cardiovascular disease, and diabetes risk.
Post-transplant hyperglycaemia frequently develops in the early weeks after kidney transplantation. This condition resembles type 2 diabetes and necessitates glucose-lowering therapy to mitigate its harmful effects. Hyperglycaemia primarily arises due to high-dose glucocorticoids or surgical stress, both of which induce insulin resistance. It is characterised by a plasma glucose level of ≥7.0 mmol/L or a 2-hour plasma glucose level of ≥11.1 mmol/L after an oral glucose tolerance test.
Early post-transplant hyperglycaemia exerts stress on pancreatic beta cells, which may contribute to the development of PTDM later on. Although hyperglycaemia may resolve with reduced doses of glucocorticoids and calcineurin inhibitors, kidney transplant recipients remain at an increased risk of PTDM, with an estimated one-year risk of 10-15%. PTDM can be diagnosed three months post-transplant, once patients are on stable immunosuppressive therapy and exhibit stable kidney graft function. Insulin resistance and steroid-induced weight gain play a significant role in the development of PTDM, with hyperglycaemia from steroids often presenting as elevated postprandial glucose levels. Glucose measurement 7-8 hours after prednisolone administration may be optimal for detecting hyperglycaemia, but an oral glucose tolerance test is considered even more effective.
Identifying post-transplant hyperglycaemia early is critical for reducing the risk of developing PTDM. Long-term, PTDM is associated with an increased risk of cardiovascular mortality and reduced graft survival.
Continuous glucose monitoring (CGM) are gradually becoming more widely used for glucose monitoring in patients with impaired glucose levels. Plasma glucose is measured every 5-15 minutes, depending on the model used, usually for 10-14 days. A sensor measures interstitial glucose, which is converted to plasma glucose levels. This provides precise measurements of plasma glucose, including during sleep and periods of variability. This enables clinicians to optimise treatment based on comprehensive glycaemic profiles.
Other metrics, such as time in range and glucose management indicator (GMI) - a calculated estimation of HbA1c based on mean glucose - are also provided by the CGM.
Few studies have explored glucose profiles by CGM immediately after kidney transplantation. A small study found a significant association between mean sensor glucose 3-5 days after renal transplantation and later development of PTDM. Data was based on glucose profiles measured by CGM on 28 kidney transplanted patients and glucose profiles also revealed higher glucose levels in the afternoon and early evening.
Design and Population:
This single-centre observational study will be conducted at Rigshospitalet in Copenhagen, Denmark. A total of 54 participants will be included, divided into three groups based on their diabetes status or most recent fasting plasma glucose and HbA1c measurements before transplantation:
- Diabetes group (n=18)
- No diabetes group (n=18)
- Prediabetes group (n=18)
Methods:
Kidney transplant recipients will receive information about the study prior to or upon admission before transplantation. Patients who meet the inclusion and exclusion criteria and provide written, informed consent will be enrolled in one of the three groups.
A CGM will be applied within 72 hours of kidney transplantation, and additional blood samples (HbA1c, C-peptide, and insulin) will be taken. The CGM will measure glucose levels for 10-14 days, depending on the model used, and additional blood samples will be collected upon CGM removal. Data during the CGM monitoring period, including medication, complications, blood samples, and vital signs, will be obtained from patients' records. Since the CGMs are double-blinded, treating physicians will adhere to guidelines for managing hyperglycaemia.
Statistical Analysis:
We will compare the mean sensor glucose levels across the three groups using analysis of variance (ANOVA) or the Kruskal-Wallis test, depending on data distribution. Post-hoc tests will identify specific group differences in glucose levels. Regression analyses, such as logistic and linear regression, will examine associations between the groups on secondary outcomes, and multivariate analysis will be conducted.
Ethical Considerations:
This study aims to contribute to understanding glucose profiles post-kidney transplantation, ultimately improving monitoring and treatment for post-transplant hyperglycaemia. Informed consent is essential to ensure participants understand the study's purpose and procedures. Special considerations will be taken to protect the autonomy and well-being of kidney transplant recipients, a potentially vulnerable population
- Conditions
- Hyperglycaemia, Kidney Transplantation
- Keywords
- Kidney transplantation, diabetes, prediabetes, hyperglycaemia, continuous glucose monitoring, CGM
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Mean Sensor Glucose
Mean sensor glucose (mmol/L) evaluated by CGM
Measured: 10 days
Secondary outcomes (9)
Time in range (%)
Time within 3.9-10.0 mmol/L as evaluated by CGM
Measured: 10 days
Compliance with applicable guideline (%)
Based on capillary blood glucose (mmol/L) and daily insulin dose (IE per day)
Measured: 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
Measured: 10 days
Time in tight glycaemic range (%)
Time in 3.9-7.8 mmol/L evaluated by CGM
Measured: 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
Measured: 10 days
Glucose variability
Standard deviation [mmol/L] and coefficient of variation [%]) evaluated by CGM
Measured: 10 days
Glucose management indicator (GMI) (mmol/mol and %)
Evaluated by CGM
Measured: 10 days
Number of hyperglycaemic events (Number/days measured)
Defined as glucose ≥10.0mmol/L for more than 15 minutes measured by CGM
Measured: 10 days
Number of hypoglycaemic events (Number/days measured)
Defined as glucose <3.9mmol/L for more than 15 minutes measured by CGM
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start12 Nov 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Feldt-Rasmussen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Feldt-Rasmussen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675903
- Sponsor's protocol ID
- H-24046404
- Acronym
- CGM-KTx
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Kidney Transplant Recipients With Diabetes, Pre-diabetes and Without Diabetes
- ClinicalTrials.gov ID
- NCT06675903
- Acronym / sponsor ID
- CGM-KTx / H-24046404
- Conditions
- Hyperglycaemia, Kidney Transplantation
- Keywords
- Kidney transplantation, diabetes, prediabetes, hyperglycaemia, continuous glucose monitoring, CGM
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Bo Feldt-RasmussenUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 days post-transplant, with insulin administered to maintain stable glucose levels. Minor studies using continuous glucose monitoring (CGM) suggest that patients, particularly those with diabetes, are prone to dysregulation. Early and optimised treatment of post-surgical hyperglycaemia may reduce the risk of later post-transplant diabetes mellitus (PTDM) and associated cardiovascular mortality and loss of graft function.
Objectives:
This study aims to investigate differences in glucose profiles during the initial two weeks following kidney transplantation among patients with diabetes, prediabetes, and no diabetes. We hypothesise that patients with pre-existing diabetes will exhibit the highest glucose levels, despite insulin treatment.
Background:
Patients with end-stage kidney disease require kidney replacement therapy, provided through haemodialysis, peritoneal dialysis, or kidney transplantation. Kidney transplantation is generally considered the best option in terms of quality of life and cost-effectiveness. However, kidney transplant recipients require complex immunosuppressive regimens and present an increased susceptibility to infection, malignancy, cardiovascular disease, and diabetes risk.
Post-transplant hyperglycaemia frequently develops in the early weeks after kidney transplantation. This condition resembles type 2 diabetes and necessitates glucose-lowering therapy to mitigate its harmful effects. Hyperglycaemia primarily arises due to high-dose glucocorticoids or surgical stress, both of which induce insulin resistance. It is characterised by a plasma glucose level of ≥7.0 mmol/L or a 2-hour plasma glucose level of ≥11.1 mmol/L after an oral glucose tolerance test.
Early post-transplant hyperglycaemia exerts stress on pancreatic beta cells, which may contribute to the development of PTDM later on. Although hyperglycaemia may resolve with reduced doses of glucocorticoids and calcineurin inhibitors, kidney transplant recipients remain at an increased risk of PTDM, with an estimated one-year risk of 10-15%. PTDM can be diagnosed three months post-transplant, once patients are on stable immunosuppressive therapy and exhibit stable kidney graft function. Insulin resistance and steroid-induced weight gain play a significant role in the development of PTDM, with hyperglycaemia from steroids often presenting as elevated postprandial glucose levels. Glucose measurement 7-8 hours after prednisolone administration may be optimal for detecting hyperglycaemia, but an oral glucose tolerance test is considered even more effective.
Identifying post-transplant hyperglycaemia early is critical for reducing the risk of developing PTDM. Long-term, PTDM is associated with an increased risk of cardiovascular mortality and reduced graft survival.
Continuous glucose monitoring (CGM) are gradually becoming more widely used for glucose monitoring in patients with impaired glucose levels. Plasma glucose is measured every 5-15 minutes, depending on the model used, usually for 10-14 days. A sensor measures interstitial glucose, which is converted to plasma glucose levels. This provides precise measurements of plasma glucose, including during sleep and periods of variability. This enables clinicians to optimise treatment based on comprehensive glycaemic profiles.
Other metrics, such as time in range and glucose management indicator (GMI) - a calculated estimation of HbA1c based on mean glucose - are also provided by the CGM.
Few studies have explored glucose profiles by CGM immediately after kidney transplantation. A small study found a significant association between mean sensor glucose 3-5 days after renal transplantation and later development of PTDM. Data was based on glucose profiles measured by CGM on 28 kidney transplanted patients and glucose profiles also revealed higher glucose levels in the afternoon and early evening.
Design and Population:
This single-centre observational study will be conducted at Rigshospitalet in Copenhagen, Denmark. A total of 54 participants will be included, divided into three groups based on their diabetes status or most recent fasting plasma glucose and HbA1c measurements before transplantation:
- Diabetes group (n=18)
- No diabetes group (n=18)
- Prediabetes group (n=18)
Methods:
Kidney transplant recipients will receive information about the study prior to or upon admission before transplantation. Patients who meet the inclusion and exclusion criteria and provide written, informed consent will be enrolled in one of the three groups.
A CGM will be applied within 72 hours of kidney transplantation, and additional blood samples (HbA1c, C-peptide, and insulin) will be taken. The CGM will measure glucose levels for 10-14 days, depending on the model used, and additional blood samples will be collected upon CGM removal. Data during the CGM monitoring period, including medication, complications, blood samples, and vital signs, will be obtained from patients' records. Since the CGMs are double-blinded, treating physicians will adhere to guidelines for managing hyperglycaemia.
Statistical Analysis:
We will compare the mean sensor glucose levels across the three groups using analysis of variance (ANOVA) or the Kruskal-Wallis test, depending on data distribution. Post-hoc tests will identify specific group differences in glucose levels. Regression analyses, such as logistic and linear regression, will examine associations between the groups on secondary outcomes, and multivariate analysis will be conducted.
Ethical Considerations:
This study aims to contribute to understanding glucose profiles post-kidney transplantation, ultimately improving monitoring and treatment for post-transplant hyperglycaemia. Informed consent is essential to ensure participants understand the study's purpose and procedures. Special considerations will be taken to protect the autonomy and well-being of kidney transplant recipients, a potentially vulnerable population
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult kidney transplant recipients at Rigshospitalet, Copenhagen, Denmark
Key inclusion criteria (3 listed)
- Written informed consent obtained before CGM application
- Male or female; age: ≥18 years
- Kidney transplantation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in Mean Sensor Glucose
Time frame: 10 days
Mean sensor glucose (mmol/L) evaluated by CGM
9 secondary outcomes
Time in range (%)
Time frame: 10 days
Compliance with applicable guideline (%)
Time frame: 10 days
Time in hypoglycaemia (%)
Time frame: 10 days
Time in tight glycaemic range (%)
Time frame: 10 days
Time i hyperglycaemia (%)
Time frame: 10 days
Glucose variability
Time frame: 10 days
Glucose management indicator (GMI) (mmol/mol and %)
Time frame: 10 days
Number of hyperglycaemic events (Number/days measured)
Time frame: 10 days
Number of hypoglycaemic events (Number/days measured)
Time frame: 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycaemia and Kidney Transplantation, run by Bo Feldt-Rasmussen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida S Voss, MD (+4535457063, Ida.voss@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Mean Sensor Glucose (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.