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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous Glucose Monitor Application
* Diagnostic Test: Finger Stick Glucose Measurement
* Drug: Insulin
* Device: Continuous Glucose Monitor Placebo Applied


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br> | Device: Continuous Glucose Monitor Application<br>* 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.<br>Diagnostic Test: Finger Stick Glucose Measurement<br>* Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals.<br>Drug: Insulin<br>* Insulin will be administered.<br>|
| Placebo Comparator: Control Arm<br> | Diagnostic Test: Finger Stick Glucose Measurement<br>* Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals.<br>Drug: Insulin<br>* Insulin will be administered.<br>Device: Continuous Glucose Monitor Placebo Applied<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Daily Glucose | The primary outcome of this study is average daily glucose level. | Postoperative day 1 - 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hyperglycemic Episodes | The number of episodes where glucose goes from <180mg/dl to ≥ 180 mg/dl. | Postoperative days 1-5 | 
| Number of Hypoglycemic Episodes | The number of episodes where glucose levels go from > 80 mg/dl to ≤ 80 mg/dl | Postoperative days 1-5 | 
| Total Insulin Use | The total number of insulin units used | Postoperative days 1-5 |