Trial Outcomes & Findings for Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery (NCT NCT00694473)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

76 participants

Primary outcome timeframe

72 hours

Results posted on

2018-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Freestyle Navigator Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU
Overall Study STARTED	76
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Freestyle Navigator n=69 Participants Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=99 Participants
Age, Categorical >=65 years	24 Participants n=99 Participants
Age, Continuous	59 years STANDARD_DEVIATION 15.2 • n=99 Participants
Sex: Female, Male Female	31 Participants n=99 Participants
Sex: Female, Male Male	38 Participants n=99 Participants
Region of Enrollment United States	69 Participants n=99 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Population: This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Mean Absolute Relative Difference (MARD) of Navigator CGM compared with reference blood glucose values

Outcome measures

Outcome measures
Measure	Freestyle Navigator n=69 Participants Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU
Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values	14.5 percent absolute relative difference Interval 13.0 to 16.0

SECONDARY outcome

Timeframe: 72 hours

Population: This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Population: This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours

Percentage of readings in different blood sugar ranges as shown by point of care testing: \< 60 mg/dl 61-120 mg/dl 121-180 mg/dl 181-240 lmg/dl \>240 mg/dl

Outcome measures

Outcome measures
Measure	Freestyle Navigator n=69 Participants Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU
Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing: <60mg/dl	10 percentage of readings
Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing: 61-120mg/dl	23 percentage of readings
Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing: 121-180mg/dl	41 percentage of readings
Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing: 181-240mg/dl	12 percentage of readings
Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing: >240mg/dl	14 percentage of readings

SECONDARY outcome

Timeframe: 72 hours

Population: MARD by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)

Mean Absolute Relative Difference (MARD) between the Navigator CGM and reference blood glucose values by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)

Outcome measures

Outcome measures
Measure	Freestyle Navigator n=69 Participants Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU
Navigator CGM Accuracy by Category None	10.1 percent absolute relative difference Standard Deviation 10.0
Navigator CGM Accuracy by Category Neurosurgery	15.1 percent absolute relative difference Standard Deviation 12.7
Navigator CGM Accuracy by Category Cardiac surgery	14.3 percent absolute relative difference Standard Deviation 14.6
Navigator CGM Accuracy by Category Hypotensive/vasopressor	18.8 percent absolute relative difference Standard Deviation 18.6
Navigator CGM Accuracy by Category Edema	9.7 percent absolute relative difference Standard Deviation 4.1

Adverse Events

Freestyle Navigator

Serious events: 0 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Freestyle Navigator n=69 participants at risk Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU
Injury, poisoning and procedural complications Bleeding at Insertion Site	5.8% 4/69 • Number of events 4 • 72 hours
Blood and lymphatic system disorders Culture proven bacteremia	1.4% 1/69 • Number of events 1 • 72 hours

Additional Information

Steven J Russell, M.D. PhD

Massachusetts General Hospital

Phone: 617-726-8722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place