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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental |
| |
| Control Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Glucose | The primary outcome of this study is average daily glucose level. | Postoperative day 1 - 5 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
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|
| 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. |
|
| Postoperative days 1-5 |
| Total Insulin Use | The total number of insulin units used | Postoperative days 1-5 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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