Trial Outcomes & Findings for Assessment of Glycemic Control in Patients With Type 2 Diabetes Mellitus and Late Stage Chronic Kidney Disease (NCT NCT03383627)

NCT ID: NCT03383627

Last Updated: 2021-04-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 14 Days
• Results posted on: 2021-04-06

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Continuous Glucose Monitoring n=80 Participants * 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.
Age, Continuous	71.3 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Cause of Chronic Kidney Disease Diabetes Mellitus Type 2	63 Participants n=5 Participants
Cause of Chronic Kidney Disease Others	17 Participants n=5 Participants
Medical History Congestive Heart Failure	20 Participants n=5 Participants
Medical History Coronary Artery Disease	26 Participants n=5 Participants
Medical History Hypertension	77 Participants n=5 Participants
Medical History History of Stroke	17 Participants n=5 Participants
Medical History History of Maliganancy	6 Participants n=5 Participants
eGFR 0 to <=15 mL/min	15 Participants n=5 Participants
eGFR >15 to <=30 mL/min	34 Participants n=5 Participants
eGFR >30 to <=45 mL/min	31 Participants n=5 Participants
BMI <=25	14 Participants n=5 Participants
BMI >25 to <=30	33 Participants n=5 Participants
BMI >30 to >=35	21 Participants n=5 Participants
BMI >35	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 Days

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

Outcome measures

Measure	Continuous Glucose Monitoring n=80 Participants Subjects enrolled and wearing CGM device
Mean Glucose Concentration Measured by CGM	151.5 mg/dL Interval 75.0 to 405.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Continuous Glucose Monitoring n=80 Participants Subjects enrolled and wearing CGM device
Number of Participants With Hypoglycemic Events	61 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Continuous Glucose Monitoring n=80 Participants Subjects enrolled and wearing CGM device
Mean Number of Hypoglycemic Events Per Participant.	7.5 Hypoglycemic events Standard Deviation 9.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Continuous Glucose Monitoring n=80 Participants Subjects enrolled and wearing CGM device
Duration Hypoglycemic Events	7.5 Percentage time with Hypoglycemia Standard Deviation 10.1

PRIMARY outcome

Timeframe: 14 Days

HbA1c collected at end of the participation.

Outcome measures

Measure	Continuous Glucose Monitoring n=80 Participants Subjects enrolled and wearing CGM device
Mean HbA1c	7.2 mmol/mol Interval 4.8 to 13.2

SECONDARY outcome

Timeframe: 14 Days

Serum fructosamine (µmol/L) collected at the end of participation.

Outcome measures

Measure	Continuous Glucose Monitoring n=80 Participants Subjects enrolled and wearing CGM device
Mean Serum Fructosamine Concentration	304.1 µmol/L Interval 177.0 to 523.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Continuous Glucose Monitoring n=80 Participants Subjects enrolled and wearing CGM device
Determination of Serum Fructosamine	304.1 µmol/L Standard Deviation 57.2

Adverse Events

Continuous Glucose Monitoring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lubaina Presswala, DO

Northwell Health

Phone: 516-708-2540

Email: lpresswala@northwell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place