Clinical trial NCT03383627: Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease
Official title: Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Kidney Diseases
Keywords: Chronic Kidney Disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Mean Glucose Concentration Measured by CGM
timeFrame: 14 Days
measure: Number of Participants With Hypoglycemic Events
timeFrame: 14 Days
measure: Mean Number of Hypoglycemic Events Per Participant.
timeFrame: 14 Days
measure: Duration Hypoglycemic Events
timeFrame: 14 Days
measure: Mean HbA1c
timeFrame: 14 Days
Secondary outcomes:
measure: Mean Serum Fructosamine Concentration
timeFrame: 14 Days
measure: Determination of Serum Fructosamine
timeFrame: 14 days
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: Northwell Health (Division Endocrinology and Nephrology)
state: New York
Study officials:
affiliation: Northwell Health
name: Lubaina Presswala, DO
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rabkin R, Ryan MP, Duckworth WC. The renal metabolism of insulin. Diabetologia. 1984 Sep;27(3):351-7. doi: 10.1007/BF00304849.
citation: Castellino P, DeFronzo RA. Glucose metabolism and the kidney. Semin Nephrol. 1990 Sep;10(5):458-63.
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.