At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Established diagnosis of type 2 Diabetes Mellitus
- ✓Chronic Kidney Disease stages 3b, 4, or 5 (eGFR <45 ml/min) and not currently on dialysis, documented within 3 months
- ✕End-stage kidney disease requiring dialysis
- ✕Hemoglobinopathies present
- ✕Red blood cell transfusion within the last 12 weeks
- ✕Hemoglobin <9 g/dL (documented within 3 months)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease
In Brief
A clinical study evaluating Continuous Glucose Monitoring for Diabetes and Kidney Diseases. Completed, enrolled 80 participants across 1 site.
Detailed Summary
Diabetes control is often assessed by tests of glucose levels over time, such as the glycosylated hemoglobin A1c (HbA1c) and fructosamine. In the later stages of chronic kidney disease (CKD) there is limited data available on the utility of these tests. There are reasons to believe that the tests may be less accurate in this population. Continuous glucose monitoring (CGM) offers an effective method for understanding the totality of glucose exposure and incidence of both hyperglycemic and hypoglycemic excursions.
Study Details
Timeline
Interventions
* The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The Freestyle Libre Pro device is FDA approved (PMA# P150021). Participants will use the FreeStyle Libre Pro Flash Glucose Monitoring device according to its approved use, on the back of the arm. * CGM monitoring will be performed on Day 1 by placing the Freestyle Libre Pro on research subjects for intended use of 14 days. * Subjects will be advised to return to the research site on Day 14 to remove the CGM device for analysis.