Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease

Diabetes Clinical Trial

Official title:

Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383627
• Other study ID #: 17-0531
• Status: Completed
• Phase: N/A
• Start date: November 30, 2017
• Est. completion date: August 21, 2018

Study information

• Verified date: March 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 21, 2018
• Est. primary completion date: August 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Filtration 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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• Continuous Glucose Monitoring
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.

Locations

Country	Name	City	State
United States	Northwell Health (Division Endocrinology and Nephrology)	Great Neck	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

Castellino P, DeFronzo RA. Glucose metabolism and the kidney. Semin Nephrol. 1990 Sep;10(5):458-63. Review. — View Citation

Dolscheid-Pommerich RC, Kirchner S, Weigel C, Eichhorn L, Conrad R, Stoffel-Wagner B, Zur B. Impact of carbamylation on three different methods, HPLC, capillary electrophoresis and TINIA of measuring HbA1c levels in patients with kidney disease. Diabetes Res Clin Pract. 2015 Apr;108(1):15-22. doi: 10.1016/j.diabres.2015.01.034. Epub 2015 Jan 29. — View Citation

Miedema K. Standardization of HbA1c and Optimal Range of Monitoring. Scand J Clin Lab Invest Suppl. 2005;240:61-72. — View Citation

Rabkin R, Ryan MP, Duckworth WC. The renal metabolism of insulin. Diabetologia. 1984 Sep;27(3):351-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Glucose Concentration Measured by CGM	Mean glucose concentration (mg/dL) will be measured using measurements taken by CGM device.	14 Days
Primary	Number of Participants With Hypoglycemic Events	Hypoglycemic event will be considered when blood sugar level is <=70 mg/dl. Detail information like time of event, number of subjects with an event, duration of event will be analyzed.	14 Days
Primary	Mean Number of Hypoglycemic Events Per Participant.	Total number of hypoglycemic events per subject will be calculated during the study period. Mean number of events per subject will be analyzed.	14 Days
Primary	Duration Hypoglycemic Events	As monitoring device measures blood glucose level numerous time, duration of hypoglycemic event will be calculated in percent time per subject based on total duration of time subject wore CGM device.	14 Days
Primary	Mean HbA1c	HbA1c collected at end of the participation.	14 Days
Secondary	Mean Serum Fructosamine Concentration	Serum fructosamine (µmol/L) collected at the end of participation.	14 Days
Secondary	Determination of Serum Fructosamine	Using blood glucose information measured with continuous blood glucose monitoring device, probable level of serum fructosamine (µmol/L) will be measured for each participant and mean will be analyzed.	14 days