Continuous Glucose Monitoring for Post-kidney Transplantation in Pre-existing Type 2 Diabetes

Use of continuous glucose monitor (CGM) in post kidney transplant patients to better assess changes in glucose levels post kidney transplant

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a non-randomized prospective single arm study with a planned enrollment of 20 patients.

Description

Inclusion Criteria:

1. Sex: men and women
2. Ethnicity: all ethnic groups
3. Age: ≥ 18
4. Known type 2 diabetes before kidney transplant
5. Kidney transplant alone
6. On multiple daily insulin injection
7. Standard prednisone taper
8. Smart phone - compatible with the LibreView App

Exclusion Criteria:

1. Simultaneous pancreas-kidney transplant
2. Allergy to Freestyle Libre components including adhesive
3. Use of vitamin C at doses 500 mg or greater
4. Blood dyscrasias that prevent hemoglobin A1c interpretation
5. Lack of mobile app accessibility
6. Rapid prednisone taper

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
Hospital Readmission	Percent of patients who experienced a hospital readmission	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	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	6 months
Rejection	Percent of patients who experienced a rejection of the transplanted kidney	6 months
Delayed graft function	Percent of patients who experienced delayed graft function	6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Actual): November 12, 2024
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: CGM; Kidney Transplant; Continuous Glucose Monitor
• Other Study ID Numbers: 23-390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No