NCT04742023

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitor Application	The Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied and values interpreted by nursing.
DIAGNOSTIC_TEST	Finger Stick Glucose Measurement	Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals.
DRUG	Insulin	Insulin will be administered.
DEVICE	Continuous Glucose Monitor Placebo Applied	The Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied however values will not be interpreted.

Timeline

• Start date: 2020-04-21
• Primary completion: 2023-11-21
• Completion: 2023-12-21
• First posted: 2021-02-05
• Last updated: 2023-12-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study