Kidney Transplant
Conditions
Keywords
CGM, Kidney Transplant, Continuous Glucose Monitor
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.
Interventions
None listed
Sponsors
The Cleveland Clinic
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range (TIR) | 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 | 6 months | Percent of patients who experienced a hospital readmission |
| Time below range (TBR) | 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) | 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 | 6 months | Percent of patients who experienced a rejection of the transplanted kidney |
| Delayed graft function | 6 months | Percent of patients who experienced delayed graft function |
Countries
United States
Outcome results
None listed