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

NeuroTherapia, Inc.

Status: Active, not recruiting

Conditions: Kidney Transplant

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07271433

23-390

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Post Kidney Transplant, using CGM

Description:

A total of 20 patients that are post kidney transplant, will wear a Continuous Glucose Monitor (CGM) until 3 months post-transplant.