Kidney TransplantNCT07271433
Continuous Glucose Monitoring for Post-kidney Transplantation in Pre-existing Type 2 Diabetes
An observational study of Kidney Transplant, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Use of continuous glucose monitor (CGM) in post kidney transplant patients to better assess changes in glucose levels post kidney transplant Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: This is a non-randomized prospective single arm study with a planned enrollment of 20 patients.
Who may be able to join
- Sex: men and women
- Ethnicity: all ethnic groups
- Age: ≥ 18
- Known type 2 diabetes before kidney transplant
- Kidney transplant alone
- On multiple daily insulin injection
- Standard prednisone taper
- Smart phone - compatible with the LibreView App
Who cannot join
- Simultaneous pancreas-kidney transplant
- Allergy to Freestyle Libre components including adhesive
- Use of vitamin C at doses 500 mg or greater
- Blood dyscrasias that prevent hemoglobin A1c interpretation
- Lack of mobile app accessibility
- Rapid prednisone taper
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Use of continuous glucose monitor (CGM) in post kidney transplant patients to better assess changes in glucose levels post kidney transplant
Read the detailed description
This is a non-randomized perspective single arm study with a planned enrollment of 20 patients. The primary objective is to characterize the glucometrics (description of glucose readings in relation to target goals) achieved by a CGM-based insulin titrating protocol for glucocorticoid taper for post kidney transplant patients. The secondary objective is to explore the relationship between the CGM glucometrics and rates of readmission, rejection and delayed graft function in post kidney transplant patients.
A total of 20 patients that are post kidney transplant, will undergo intervention until 3 months post-transplant. Informed consent will be obtained prior to start of study. The final visit will be at 3 months. Patients will be discharged to their local endocrinologist or primary care physician at this 3-month mark. Data will continue to be gathered for 3 more months after exit from intervention. Enrollment will be within the first 2 weeks of hospital discharge. Visits are standard of care (SOC) at the Kidney Transplant Clinic or at the Endocrinology clinic and will be virtual, in-person or telephone encounter.
- Conditions
- Kidney Transplant
- Keywords
- CGM, Kidney Transplant, Continuous Glucose Monitor
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 |
|---|---|---|
| Post Kidney Transplant, using CGM | A total of 20 patients that are post kidney transplant, will wear a Continuous Glucose Monitor (CGM) until 3 months post-transplant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range (TIR)
Percent of patients who achieved Time in Range (55 mg/dL to 180 mg/dL Glucose) as measured by the Continuous Glucose Monitor
Measured: 6 months
Hospital Readmission
Percent of patients who experienced a hospital readmission
Measured: 6 months
Time below range (TBR)
Percent of patients who achieved Time below range (<54 mg/dL Glucose) as measured by the Continuous Glucose Monitor
Measured: 6 months
Time above range (TAR)
Percent of patients who achieved Time above range (181-250mg/dL and >250 mg/dL Glucose) as measured by the Continuous Glucose Monitor
Measured: 6 months
Rejection
Percent of patients who experienced a rejection of the transplanted kidney
Measured: 6 months
Delayed graft function
Percent of patients who experienced delayed graft function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start29 Jan 2024
- Primary completion12 Nov 2024
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271433
- Sponsor's protocol ID
- 23-390
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to the disclosure on the consent form for which IRB approval was received. Deidentified summarized results will be shared via publication in a medical journal
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring for Post-kidney Transplantation in Pre-existing Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07271433
- Acronym / sponsor ID
- 23-390
- Conditions
- Kidney Transplant
- Keywords
- CGM, Kidney Transplant, Continuous Glucose Monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 9 Dec 2025 (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.
Use of continuous glucose monitor (CGM) in post kidney transplant patients to better assess changes in glucose levels post kidney transplant
Detailed description
This is a non-randomized perspective single arm study with a planned enrollment of 20 patients. The primary objective is to characterize the glucometrics (description of glucose readings in relation to target goals) achieved by a CGM-based insulin titrating protocol for glucocorticoid taper for post kidney transplant patients. The secondary objective is to explore the relationship between the CGM glucometrics and rates of readmission, rejection and delayed graft function in post kidney transplant patients.
A total of 20 patients that are post kidney transplant, will undergo intervention until 3 months post-transplant. Informed consent will be obtained prior to start of study. The final visit will be at 3 months. Patients will be discharged to their local endocrinologist or primary care physician at this 3-month mark. Data will continue to be gathered for 3 more months after exit from intervention. Enrollment will be within the first 2 weeks of hospital discharge. Visits are standard of care (SOC) at the Kidney Transplant Clinic or at the Endocrinology clinic and will be virtual, in-person or telephone encounter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post Kidney Transplant, using CGM | – | –A total of 20 patients that are post kidney transplant, will wear a Continuous Glucose Monitor (CGM) until 3 months post-transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a non-randomized prospective single arm study with a planned enrollment of 20 patients.
Key inclusion criteria (8 listed)
- Sex: men and women
- Ethnicity: all ethnic groups
- Age: ≥ 18
- Known type 2 diabetes before kidney transplant
- Kidney transplant alone
Key exclusion criteria (6 listed)
- Simultaneous pancreas-kidney transplant
- Allergy to Freestyle Libre components including adhesive
- Use of vitamin C at doses 500 mg or greater
- Blood dyscrasias that prevent hemoglobin A1c interpretation
- Lack of mobile app accessibility
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
Time in Range (TIR)
Time frame: 6 months
Percent of patients who achieved Time in Range (55 mg/dL to 180 mg/dL Glucose) as measured by the Continuous Glucose Monitor
Hospital Readmission
Time frame: 6 months
Percent of patients who experienced a hospital readmission
Time below range (TBR)
Time frame: 6 months
Percent of patients who achieved Time below range (<54 mg/dL Glucose) as measured by the Continuous Glucose Monitor
Time above range (TAR)
Time frame: 6 months
Percent of patients who achieved Time above range (181-250mg/dL and >250 mg/dL Glucose) as measured by the Continuous Glucose Monitor
Rejection
Time frame: 6 months
Percent of patients who experienced a rejection of the transplanted kidney
Delayed graft function
Time frame: 6 months
Percent of patients who experienced delayed graft function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to the disclosure on the consent form for which IRB approval was received. Deidentified summarized results will be shared via publication in a medical journal
Related trials for Kidney Transplant
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Kidney Transplant, run by The Cleveland Clinic at 1 site in United States.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 23 Feb 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Range (TIR) (time frame: 6 months). The study lists 6 primary outcomes in all. 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 23 Feb 2026.