Skip to main content
OpenTrials
Completed

NCT Number: NCT04742023

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Finger Stick Glucose Measurement

Diagnostic Test

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

Insulin

Drug

Insulin will be administered.

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.

Primary outcomes

  1. Average Daily Glucose

    Time frame: Postoperative day 1 - 5

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

Secondary outcomes

  1. Number of Hyperglycemic Episodes

    Time frame: Postoperative days 1-5

    The number of episodes where glucose goes from <180mg/dl to ≥ 180 mg/dl.

  2. Number of Hypoglycemic Episodes

    Time frame: Postoperative days 1-5

    The number of episodes where glucose levels go from > 80 mg/dl to ≤ 80 mg/dl

  3. Total Insulin Use

    Time frame: Postoperative days 1-5

    The total number of insulin units used

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2021
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.