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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose Monitor Application; Diagnostic test: Finger Stick Glucose Measurement; Drug: Insulin; Device: Continuous Glucose Monitor Placebo Applied

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm	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.
Placebo Comparator: Control Arm	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Glucose	The primary outcome of this study is average daily glucose level.	Postoperative day 1 - 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hyperglycemic Episodes	The number of episodes where glucose goes from <180mg/dl to ≥ 180 mg/dl.	Postoperative days 1-5
Number of Hypoglycemic Episodes	The number of episodes where glucose levels go from > 80 mg/dl to ≤ 80 mg/dl	Postoperative days 1-5
Total Insulin Use	The total number of insulin units used	Postoperative days 1-5

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2020
• Primary Completion (Actual): November 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Postoperative Complications; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 20-0066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No