Trial Outcomes & Findings for Glucose Time-In-Range Development Evaluation (NCT NCT03670017)

NCT ID: NCT03670017

Last Updated: 2021-10-19

Results Overview

Glucose time in range will be defined by participant's clinical care defined target glucose range

Recruitment status

TERMINATED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

Up to 72 hours

Results posted on

2021-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Time In Range During OptiScanner Connection Participants will be connected to the OptiScanner 5000 for up to 72 hours. OptiScanner® 5000 Glucose Monitoring System: The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device \[i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed.
Overall Study STARTED	68
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glucose Time-In-Range Development Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Time In Range During OptiScanner Connection n=50 Participants Participants will be connected to the OptiScanner 5000 for up to 72 hours. OptiScanner® 5000 Glucose Monitoring System: The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device \[i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	7 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 72 hours

Population: The percentage of time in range is all that is available. The company declared bankruptcy due to COVID 19. Raw data is no longer available.

Glucose time in range will be defined by participant's clinical care defined target glucose range

Outcome measures

Outcome measures
Measure	Time In Range During OptiScanner Connection n=50 Participants Participants will be connected to the OptiScanner 5000 for up to 72 hours. OptiScanner® 5000 Glucose Monitoring System: The study population includes surgical critical care patients who require blood glucose monitoring. Subjects must have a vascular access device \[i.e., Central Venous Catheters (CVC), Multi-lumen Access Catheters (MAC) either in place or to be placed with an expected usage of at least 48 hours. During Phase One of the trial, patients will be connected to the OptiScanner for up to 72 hours and the hospital's current standard of care for glucose management will be followed.
Glucose Time-in-range (TIR)	55 percentage of time in range

SECONDARY outcome

Timeframe: Up to 72 hours

Population: The sponsor went out of business prior to completing the analysis for this endpoint therefore the information is not available.

Evaluation of the amount of time required for a patient to have in range glucose values

Outcome measures

Outcome data not reported

Adverse Events

Time In Range During OptiScanner Connection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Grant Bochicchio, Harry Edison Professor of Surgery, Chief of Acute and Critical Care Surgery

Washington University School of Medicine

Phone: 314-362-9347

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place