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

Primary Purpose

Diabetes Mellitus

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitor Application
Finger Stick Glucose Measurement
Insulin
Continuous Glucose Monitor Placebo Applied
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • North Shore University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Arm

Control Arm

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Hyperglycemic Episodes
The number of episodes where glucose goes from <180mg/dl to ≥ 180 mg/dl.
Number of Hypoglycemic Episodes
The number of episodes where glucose levels go from > 80 mg/dl to ≤ 80 mg/dl
Total Insulin Use
The total number of insulin units used

Full Information

First Posted
January 28, 2021
Last Updated
January 10, 2023
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04742023
Brief Title
Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation
Official Title
Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Title
Control Arm
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor Application
Intervention Description
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 Type
Diagnostic Test
Intervention Name(s)
Finger Stick Glucose Measurement
Intervention Description
Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals.
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin will be administered.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor Placebo Applied
Intervention Description
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 Outcome Measure Information:
Title
Average Daily Glucose
Description
The primary outcome of this study is average daily glucose level.
Time Frame
Postoperative day 1 - 5
Secondary Outcome Measure Information:
Title
Number of Hyperglycemic Episodes
Description
The number of episodes where glucose goes from <180mg/dl to ≥ 180 mg/dl.
Time Frame
Postoperative days 1-5
Title
Number of Hypoglycemic Episodes
Description
The number of episodes where glucose levels go from > 80 mg/dl to ≤ 80 mg/dl
Time Frame
Postoperative days 1-5
Title
Total Insulin Use
Description
The total number of insulin units used
Time Frame
Postoperative days 1-5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elliot I Grodstein, MD
Phone
5164725800
Email
egrodstein@northwell.edu
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elliot I Grodstein
Phone
516-472-5800
Email
egrodstein@northwell.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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