Glucose Time-In-Range Development Evaluation

NCT ID: NCT03670017

Last Updated: 2021-10-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-06
• Study Completion Date: 2020-09-04

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.

Conditions

ICU; Dysglycemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Time In Range during OptiScanner Connection

Participants will be connected to the OptiScanner 5000 for up to 72 hours.

Group Type: OTHER

OptiScanner® 5000 Glucose Monitoring System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent by the participant or his/her legally authorized representative;

2. At least 18 years old;

3. Admitted to a Surgical Intensive Care Unit (SICU) or planned admission to a Surgical ICU at time of screening

4. Expected SICU stay of at least 48 hours at the time of enrollment

5. A vascular access device available for connection to the OptiScanner is either already in-place, or is planned to be placed with an expected usage of at least 48 hours.

Exclusion Criteria

1. Positive Human chorionic gonadotropin (HcG) (serum or urine ) in women of childbearing potential (age < 60) who are not known to be surgically sterile and those that are obviously pregnant.

2. Patients undergoing peritoneal dialysis within the past week.

3. Patients actively receiving intravenous immunoglobulin therapy.

4. Patients receiving intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer.

5. Patients following the administration of a D-Xylose absorption test < 12 hours

6. Patients being treated with Sodium Thiosulfate

7. Patients being receiving IV glycerol

8. Patients receiving substances containing maltose, or substances that can be metabolized into maltose. These substances include Extraneal, Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid.

9. Hct <15% within 24 hours of screening visit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OptiScan Biomedical Corporation

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grant Bochicchio, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Barnes Jewish Hospital

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

GIDE Study

Identifier Type: -

Identifier Source: org_study_id