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Completed

NCT Number: NCT07271433

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

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Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

  2. Hospital Readmission

    Time frame: 6 months

    Percent of patients who experienced a hospital readmission

  3. 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

  4. 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

  5. Rejection

    Time frame: 6 months

    Percent of patients who experienced a rejection of the transplanted kidney

  6. Delayed graft function

    Time frame: 6 months

    Percent of patients who experienced delayed graft function

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Abbott Medical Devices

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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