Glucose Time-In-Range Development Evaluation

Not Applicable

Terminated

• Conditions: ICU; Dysglycemia
• Interventions: Device: OptiScanner® 5000 Glucose Monitoring System

• Registration Number: NCT03670017
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The study will evaluate patients requiring frequent glucose monitoring in a Surgical ICU. 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.

Detailed Description

Hyperglycemia, hypoglycemia and glycemic variability are independently associated with morbidity and mortality of critically ill patients. Blood glucose control with insulin has the potential to decrease morbidity and mortality of intensive care unit (ICU) patients. Blood glucose control with insulin, however, is associated with an increased risk of hypoglycemia and may not decrease glycemic variability. In addition, blood glucose control with insulin utilizing manual systems for glucose measurement is blood-consuming and time-consuming, since frequent blood draws for glucose measurements are necessary in order to achieve blood glucose control.

Automated, frequent, plasma-based glucose monitoring with the OptiScanner 5000 glucose monitoring system has the potential to improve a patient's glucose TIR by improving all 3 domains of glycemic control: reducing hyperglycemia while at the same time preventing hypoglycemia and reducing glycemic variability. Second, it could reduce the workloads associated with the high number of blood samples to be obtained and analyzed.

The primary objective of this study is to observe the Time-in-Range for patients whose glycemic control is being monitored with the OptiScanner system. A secondary objective is assessment of the time it takes the patient to achieve in range glucose values while connected to the OptiScanner. The study will evaluate patients requiring frequent glucose monitoring in a Surgical ICU.

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. Currently glucose values are measured using point of care glucose meters and/or by collecting a blood sample and sending it to the hospital laboratory. Patients' glucose values are currently monitored depending on their clinical condition with the frequency of glucose measurement typically occurring every one to four hours. Patients enrolled in this study will still be monitored in this same manner, depending on their clinical condition (using point of care meters and/or blood collection for the lab). The additional continuous monitoring provided by the OptiScanner may introduce additional glucose measurements. The clinical care team will be advised to confirm any OptiScanner glucose value (using routine clinical care methods) before making any modifications to the patient's clinical care based on the OptiScanner result (i.e. increase, decrease, stop insulin drip, etc.). A research team member will be at the bedside during the patients' connection to the OptiScanner to ensure that the clinical team does not use the OptiScanner results to direct patient care and to observe the overall clinical care glucose management of the patient. Clinical data will be captured on the participants.

Study Timeline

• Study Start: 2018-09-06
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-04
• Results First Submitted: 2021-08-25
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Results First Posted: 2021-10-19
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Time In Range during OptiScanner Connection	OptiScanner® 5000 Glucose Monitoring System	Participants will be connected to the OptiScanner 5000 for up to 72 hours.

Primary Outcome Measures

Name	Time	Method
Glucose Time-in-range (TIR)	Up to 72 hours	Glucose time in range will be defined by participant's clinical care defined target glucose range

Secondary Outcome Measures

Name	Time	Method
Assessment of the Time it Takes the Patient to Achieve in Range Glucose Values While Connected to the OptiScanner.	Up to 72 hours	Evaluation of the amount of time required for a patient to have in range glucose values

Trial Locations

Locations (1)

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States