Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation

• Status: Enrolling by invitation
• Trial end date: 2021-12-21
• Target enrollment: 0
• Participant gender: All

Summary

This will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the Medtronic Guardian™ Sensor 3 continuous glucose monitor. The investigators will compare the average daily glucose level in the post-operative period (through post-operative day five) between the two arms in patients with diabetic nephropathy immediately post-renal transplant. This will serve as a pilot study to in order to power a main study.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: Insulin

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 18 years or older

4. Undergoing first-time renal transplantation

5. Have a pre-existing diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

1. Age less than 18 years

2. History of prior renal transplant

3. Use of continuous glucose monitoring or insulin pump at time of transplant

4. Insulin infusion requirement during hospitalization

5. Pregnancy or lactation

6. Known allergic reaction to Guardian™ Sensor 3 or adhesives

7. Use of peritoneal dialysis

8. Diagnosis of Type 1 diabetes mellitus

9. History of hypoglycemia unawareness