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Glucose Time-In-Range Development Evaluation (GIDE)

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ClinicalTrials.gov Identifier: NCT03670017
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
OptiScan Biomedical Corporation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
ICU Dysglycemia Device: OptiScanner® 5000 Glucose Monitoring System Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: GIDE - Glucose Time-In-Range Development Evaluation
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Time In Range during OptiScanner Connection
Participants will be connected to the OptiScanner 5000 for up to 72 hours.
Device: 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.




Primary Outcome Measures :
  1. Glucose Time-in-range (TIR) [ Time Frame: Up to 72 hours ]
    Glucose time in range will be defined by participant's clinical care defined target glucose range


Secondary Outcome Measures :
  1. Assessment of the time it takes the patient to achieve in range glucose values while connected to the OptiScanner. [ Time Frame: Up to 72 hours ]
    Evaluation of the amount of time required for a patient to have in range glucose values



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670017


Contacts
Contact: Bryan Sato, RN 314-362-1176 bryansato@wustl.edu
Contact: Kelly Bochicchio, RN 314-362-9347 bochicchiok@wustl.edu

Locations
United States, Missouri
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kelly Bochicchio, MS, RN    314-286-2965    bochicchiok@wustl.edu   
Contact: Bryan Sato, RN    314-362-1065    bryansato@wustl.edu   
Principal Investigator: Grant Bochicchio, MD, MPH         
Sponsors and Collaborators
Washington University School of Medicine
OptiScan Biomedical Corporation
Investigators
Principal Investigator: Grant Bochicchio, MD MPH Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03670017     History of Changes
Other Study ID Numbers: GIDE Study
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes