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

NCT03383627 | Completed Results FDA Device

• 1 other identifier: 17-0531
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Kidney Diseases

Keywords

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (5)

• Mean Glucose Concentration Measured by CGM

  Mean glucose concentration (mg/dL) will be measured using measurements taken by CGM device.

  14 Days

• 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

• 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

• 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

• Mean HbA1c

  HbA1c collected at end of the participation.

  14 Days

Secondary Outcomes (2)

• Mean Serum Fructosamine Concentration

  14 Days

• Determination of Serum Fructosamine

  14 days

Study Arms (1)

Continuous glucose monitoring

EXPERIMENTAL

* 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.

Device: Continuous Glucose Monitoring

Interventions

Continuous Glucose Monitoring 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.

Continuous glucose monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health (Division Endocrinology and Nephrology)

Great Neck, New York, 11021, United States

Location

Related Publications (4)

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

  PMID: 16112961 BACKGROUND

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

  PMID: 6389240 BACKGROUND

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

  PMID: 2236987 BACKGROUND

• 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.

  PMID: 25684605 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Kidney Diseases; Renal Insufficiency, Chronic

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Limitations and Caveats

The sample size of 80 patients were predominately male and non-Hispanic. It would also have been meaningful to have more robust data of a diary of self-reported symptoms during the 14 day period.

Results Point of Contact

• Title: Lubaina Presswala, DO
• Organization: Northwell Health

lpresswala@northwell.edu

516-708-2540

Study Officials

• Lubaina Presswala, DO

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: December 26, 2017
• Study Start: November 30, 2017
• Primary Completion: August 21, 2018
• Study Completion: August 21, 2018
• Last Updated: April 6, 2021
• Results First Posted: April 7, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)