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

Last updated: December 22, 2023
Sponsor: Northwell Health
Overall Status: Completed

Phase

1

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

Insulin

Finger Stick Glucose Measurement

Continuous Glucose Monitor Placebo Applied

Clinical Study ID

NCT04742023
20-0066
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for theduration 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

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 Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Insulin
Phase: 1
Study Start date:
April 21, 2020
Estimated Completion Date:
December 21, 2023

Connect with a study center

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

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