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

NCT ID: NCT04742023

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-21

Study Completion Date

2023-12-21

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Arm

Group Type EXPERIMENTAL

Continuous Glucose Monitor Application

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Insulin

Intervention Type DRUG

Insulin will be administered.

Control Arm

Group Type PLACEBO_COMPARATOR

Finger Stick Glucose Measurement

Intervention Type DIAGNOSTIC_TEST

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

Insulin

Intervention Type DRUG

Insulin will be administered.

Continuous Glucose Monitor Placebo Applied

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Finger Stick Glucose Measurement

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

Intervention Type DIAGNOSTIC_TEST

Insulin

Insulin will be administered.

Intervention Type DRUG

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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North Shore University Hospital

Manhasset, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20-0066

Identifier Type: -

Identifier Source: org_study_id