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

NCT ID: NCT03383627

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2018-08-21

Brief 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.

Detailed 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.

Conditions

Diabetes; Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Continuous glucose monitoring

• If subjects meet inclusion criteria then they will return to the research site on Day 1 to place Freestyle Libre Pro device by the research staff for 14-day monitoring.
• Subjects will be advised to return to the research site on Day 14 to remove the CGM device for analysis. On Day 14, blood will be drawn for HbA1c and fructosamine, The blood drawn for this research will be approximately 10-15 milliliters.
• There are no drug washout periods. Subjects will continue to take all their medications and/or insulins as prescribed by their doctor.
• Baseline data including age, race, ethnicity, past medical history, home medication list, and diabetes related laboratory data will be collected.

Group Type: EXPERIMENTAL

Continuous Glucose Monitoring

Intervention Type: DEVICE

• 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Lubaina Presswala

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lubaina Presswala, DO

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Northwell Health (Division Endocrinology and Nephrology)

Great Neck, New York, United States

Countries

United States

References

Miedema K. Standardization of HbA1c and Optimal Range of Monitoring. Scand J Clin Lab Invest Suppl. 2005;240:61-72. doi: 10.1080/00365510500236143.

Reference Type: BACKGROUND

PMID: 16112961 (View on PubMed)

Rabkin R, Ryan MP, Duckworth WC. The renal metabolism of insulin. Diabetologia. 1984 Sep;27(3):351-7. doi: 10.1007/BF00304849.

Reference Type: BACKGROUND

PMID: 6389240 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 2236987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25684605 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

17-0531

Identifier Type: -

Identifier Source: org_study_id