Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease
Completed · Not applicable
Conditions studied: Diabetes, Kidney Diseases
In brief
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.
Key facts
- Study ID
- NCT03383627
- Run by
- Northwell Health
- People needed
- 80
- Starts
- 2017-11-30
- Expected to finish
- 2018-08-21
- Last updated by the study team
- 2021-04-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years and older with ability to speak and understand English
- Established diagnosis of type 2 Diabetes Mellitus
- Chronic Kidney Disease (stages 3b, 4 or 5, eGFR (Glomerular Filtration Rate) < 45 ml/min, and not on dialysis) documented within 3 months of enrollment
You may not qualify if…
- Type 2 Diabetes Mellitus.
- Patient with End stage kidney disease on Dialysis.
- Presence of Hemoglobinopathies.
- Red blood cell transfusion in the last 12 weeks.
- Hb < 9 g/dL documented within 3 months of enrollment - Dosing with an erythropoiesis stimulating agent is acceptable but dose must be stable for two months.
- Use of acetaminophen on a daily basis.
- Systemic steroid treatment in the past 12 weeks.
- Greater than 50% dose change in diabetes medications or new diabetes medications started in the previous 8 weeks.
- Currently pregnant.
Where it is running
- Northwell Health (Division Endocrinology and Nephrology) — Great Neck, New York, United States
Full record on ClinicalTrials.gov
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