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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-29

Study Completion Date

2026-01-01

Brief Summary

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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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Detailed Description

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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

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Kidney Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No