Diabetes, Kidney Diseases
Conditions
Keywords
Chronic Kidney Disease
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.
Interventions
DEVICEContinuous 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.
Sponsors
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hypoglycemic Events | 14 Days | 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. |
| Duration Hypoglycemic Events | 14 Days | 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. |
| Mean HbA1c | 14 Days | HbA1c collected at end of the participation. |
| Mean Glucose Concentration Measured by CGM | 14 Days | Mean glucose concentration (mg/dL) will be measured using measurements taken by CGM device. |
| Mean Number of Hypoglycemic Events Per Participant. | 14 Days | Total number of hypoglycemic events per subject will be calculated during the study period. Mean number of events per subject will be analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Serum Fructosamine | 14 days | 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. |
| Mean Serum Fructosamine Concentration | 14 Days | Serum fructosamine (µmol/L) collected at the end of participation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitoring |
|---|---|
| Age, Continuous | 71.3 years STANDARD_DEVIATION 10.9 |
| BMI <=25 | 14 Participants |
| BMI >25 to <=30 | 33 Participants |
| BMI >30 to >=35 | 21 Participants |
| BMI >35 | 12 Participants |
| Cause of Chronic Kidney Disease Diabetes Mellitus Type 2 | 63 Participants |
| Cause of Chronic Kidney Disease Others | 17 Participants |
| eGFR 0 to <=15 mL/min | 15 Participants |
| eGFR >15 to <=30 mL/min | 34 Participants |
| eGFR >30 to <=45 mL/min | 31 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Medical History Congestive Heart Failure | 20 Participants |
| Medical History Coronary Artery Disease | 26 Participants |
| Medical History History of Maliganancy | 6 Participants |
| Medical History History of Stroke | 17 Participants |
| Medical History Hypertension | 77 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
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.
Time frame: 14 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Duration Hypoglycemic Events | 7.5 Percentage time with Hypoglycemia | Standard Deviation 10.1 |
Primary
Mean Glucose Concentration Measured by CGM
Mean glucose concentration (mg/dL) will be measured using measurements taken by CGM device.
Time frame: 14 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring | Mean Glucose Concentration Measured by CGM | 151.5 mg/dL |
Primary
Mean HbA1c
HbA1c collected at end of the participation.
Time frame: 14 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring | Mean HbA1c | 7.2 mmol/mol |
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.
Time frame: 14 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Mean Number of Hypoglycemic Events Per Participant. | 7.5 Hypoglycemic events | Standard Deviation 9 |
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.
Time frame: 14 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Continuous Glucose Monitoring | Number of Participants With Hypoglycemic Events | 61 Participants |
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.
Time frame: 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Glucose Monitoring | Determination of Serum Fructosamine | 304.1 µmol/L | Standard Deviation 57.2 |
Secondary
Mean Serum Fructosamine Concentration
Serum fructosamine (µmol/L) collected at the end of participation.
Time frame: 14 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continuous Glucose Monitoring | Mean Serum Fructosamine Concentration | 304.1 µmol/L |