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The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KidneyIntelX | Diagnostic Test | KidneyIntelX is a blood-based clinical diagnostic tool that assesses the risk of progressive kidney function decline in chronic kidney disease patients with type 2 diabetes. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Proportion (target: 20% increase from prior measurements) of visits in which each participant achieves target blood pressure of <140/90 mmHg (as per the NKF CKD management guidelines). | 12 Months |
| HbA1c | Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c. | 12 Months |
| ACEi/ARB | Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers. | 12 Months |
| SGLT2/ GLP1 | Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists. | 12 Months |
| Urine albumin to creatinine ratio | In those with baseline albuminuria, proportion (target: 20%) of patients achieving a 30% decrease in their urine albumin to creatinine ratio from averaged pre-enrollment values to average post-enrollment values through 1 year. | 12 Months |
| Referrals | Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Type 2 diabetes and existing chronic kidney disease stages 1-3.
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| Name | Affiliation | Role |
|---|---|---|
| David W Lam, MD | Mount Sinai Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Health System | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |