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

Northwell Health

Status and phase: Completed; Early Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Insulin; Device: Continuous Glucose Monitor Placebo Applied; Device: Continuous Glucose Monitor Application; Diagnostic Test: Finger Stick Glucose Measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04742023

20-0066

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. Use of insulin pump at time of transplant
3. Insulin infusion requirement during hospitalization
4. Pregnancy or lactation
5. Known allergic reaction to Guardian™ Sensor 3 or adhesives
6. History of hypoglycemia unawareness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Intervention Arm

Experimental group

Treatment:

Drug: Insulin

Device: Continuous Glucose Monitor Application

Diagnostic Test: Finger Stick Glucose Measurement

Control Arm

Placebo Comparator group

Treatment:

Drug: Insulin

Device: Continuous Glucose Monitor Placebo Applied

Diagnostic Test: Finger Stick Glucose Measurement