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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous glucose monitoring | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Serum Fructosamine Concentration | Serum fructosamine (µmol/L) collected at the end of participation. | 14 Days |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lubaina Presswala, DO | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwell Health (Division Endocrinology and Nephrology) | Great Neck | New York | 11021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16112961 | Background | Miedema K. Standardization of HbA1c and Optimal Range of Monitoring. Scand J Clin Lab Invest Suppl. 2005;240:61-72. doi: 10.1080/00365510500236143. | |
| 6389240 | Background | Rabkin R, Ryan MP, Duckworth WC. The renal metabolism of insulin. Diabetologia. 1984 Sep;27(3):351-7. doi: 10.1007/BF00304849. |
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Access to study data will be limited to Institutional Review Board (IRB) approved personnel only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Glucose Monitoring |
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Glucose Monitoring |
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Glucose Concentration Measured by CGM | Mean glucose concentration (mg/dL) will be measured using measurements taken by CGM device. | Posted | Mean | Inter-Quartile Range | mg/dL | 14 Days |
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Over the period of study participation (Up to 14 days from date of enrollment).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continuous Glucose Monitoring |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lubaina Presswala, DO | Northwell Health | 516-708-2540 | lpresswala@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2018 | Nov 21, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 22, 2018 | Feb 26, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| 14 days |
| 2236987 | Background | Castellino P, DeFronzo RA. Glucose metabolism and the kidney. Semin Nephrol. 1990 Sep;10(5):458-63. |
| 25684605 | 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Cause of Chronic Kidney Disease | Count of Participants | Participants |
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| Medical History | Count of Participants | Participants |
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| eGFR | Count of Participants | Participants |
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| BMI | Count of Participants | Participants |
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| 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. | Posted | Count of Participants | Participants | 14 Days |
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|
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| 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. | Posted | Mean | Standard Deviation | Hypoglycemic events | 14 Days |
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| 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. | Posted | Mean | Standard Deviation | Percentage time with Hypoglycemia | 14 Days |
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| Primary | Mean HbA1c | HbA1c collected at end of the participation. | Posted | Mean | Inter-Quartile Range | mmol/mol | 14 Days |
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| Secondary | Mean Serum Fructosamine Concentration | Serum fructosamine (µmol/L) collected at the end of participation. | Posted | Mean | Inter-Quartile Range | µmol/L | 14 Days |
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| 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. | Posted | Mean | Standard Deviation | µmol/L | 14 days |
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| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
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| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |