Continuous Glucose Monitoring for Post-kidney Transplantation in Pre-existing Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Hospital Readmission
Overview
Brief Summary
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sex: men and women
- •Ethnicity: all ethnic groups
- •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
Arms & Interventions
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.
Outcomes
Primary Outcomes
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
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
Delayed graft function
Time Frame: 6 months
Percent of patients who experienced delayed graft function
Secondary Outcomes
No secondary outcomes reported