Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2018 |
| Start Date: | November 30, 2017 |
| End Date: | August 21, 2018 |
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.
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.
In the proposed study Investigator plan to utilize CGM in patients with late stage CKD stages
3b-5 to 1) determine accuracy of HbA1c and serum fructosamine testing as measures of glucose
control in patients with Type 2 Diabetes Mellitus (T2DM), 2) Better understand test
characteristics in the late stage CKD population (correlation, linear equation, slope, Y
intercept, average glucose at different HbA1c levels), 3) Develop a preliminary understanding
of how test characteristics differ in late stage CKD compared to other patients with
diabetes, 4) quantify time burden and number of episodes of hypoglycemia, 4) study
hyperglycemic burden and 5) analyze glucose variability. The research staff will explain the
study to patients that meet all inclusion criteria. Patients will get time to understand the
study, review the consent document, ask questions to the PI, and then provide their consent
to participate in the study. On Day 1 of the study, a CGM (Freestyle Libre) device will be
placed on patients with CKD 3b-5 which will be worn for 14 consecutive days. Patients will
return on Day 14 to remove the CGM device. HbA1c and fructosamine values will be drawn on Day
14 and these results will be compared with average glucose monitoring values as recorded on
the CGM device. Incidence, duration, and severity of both hypoglycemic and hyperglycemic
events will be analyzed. Investigators hypothesis that there will be significant variability
in the serum HbA1c values when compared with calculated HbA1c from CGM readings.
Investigators also hypothesize that the results will reflect a greater incidence of
hypoglycemia in this population by CGM analysis.
3b-5 to 1) determine accuracy of HbA1c and serum fructosamine testing as measures of glucose
control in patients with Type 2 Diabetes Mellitus (T2DM), 2) Better understand test
characteristics in the late stage CKD population (correlation, linear equation, slope, Y
intercept, average glucose at different HbA1c levels), 3) Develop a preliminary understanding
of how test characteristics differ in late stage CKD compared to other patients with
diabetes, 4) quantify time burden and number of episodes of hypoglycemia, 4) study
hyperglycemic burden and 5) analyze glucose variability. The research staff will explain the
study to patients that meet all inclusion criteria. Patients will get time to understand the
study, review the consent document, ask questions to the PI, and then provide their consent
to participate in the study. On Day 1 of the study, a CGM (Freestyle Libre) device will be
placed on patients with CKD 3b-5 which will be worn for 14 consecutive days. Patients will
return on Day 14 to remove the CGM device. HbA1c and fructosamine values will be drawn on Day
14 and these results will be compared with average glucose monitoring values as recorded on
the CGM device. Incidence, duration, and severity of both hypoglycemic and hyperglycemic
events will be analyzed. Investigators hypothesis that there will be significant variability
in the serum HbA1c values when compared with calculated HbA1c from CGM readings.
Investigators also hypothesize that the results will reflect a greater incidence of
hypoglycemia in this population by CGM analysis.
Inclusion Criteria:
- 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 Filteration Rate) < 45
ml/min, and not on dialysis) documented within 3 months of enrollment
Exclusion Criteria:
- 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.
We found this trial at
1
site
865 Northern Boulevard
Great Neck, New York 11021
Great Neck, New York 11021
Principal Investigator: Isabela Romao, MD
Phone: 516-562-2945
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