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

NCT04742023 | Completed Early Phase 1 FDA Device

• 1 other identifier: 20-0066
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Average Daily Glucose

  The primary outcome of this study is average daily glucose level.

  Postoperative day 1 - 5

Secondary Outcomes (3)

• Number of Hyperglycemic Episodes

  Postoperative days 1-5

• Number of Hypoglycemic Episodes

  Postoperative days 1-5

• Total Insulin Use

  Postoperative days 1-5

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

PLACEBO COMPARATOR

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

Interventions

Continuous Glucose Monitor Application DEVICE

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.

Intervention Arm

Finger Stick Glucose Measurement DIAGNOSTIC_TEST

Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals.

Control Arm; Intervention Arm

Insulin DRUG

Insulin will be administered.

Control Arm; Intervention Arm

Continuous Glucose Monitor Placebo Applied DEVICE

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.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 years or older
• Undergoing first-time renal transplantation
• Have a pre-existing diagnosis of Type 2 diabetes mellitus

You may not qualify if:

• Age less than 18 years
• Use of insulin pump at time of transplant
• Insulin infusion requirement during hospitalization
• Pregnancy or lactation
• Known allergic reaction to Guardian™ Sensor 3 or adhesives
• History of hypoglycemia unawareness

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 5, 2021
• Study Start: April 21, 2020
• Primary Completion: November 21, 2023
• Study Completion: December 21, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

US (1)