Glucose Time-In-Range Development Evaluation (GIDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03670017|
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|ICU Dysglycemia||Device: OptiScanner® 5000 Glucose Monitoring System||Not Applicable|
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)|
|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|
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.
- 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
- 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
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
|Contact: Bryan Sato, RNemail@example.com|
|Contact: Kelly Bochicchio, RNfirstname.lastname@example.org|
|United States, Missouri|
|Barnes Jewish Hospital||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Kelly Bochicchio, MS, RN 314-286-2965 email@example.com|
|Contact: Bryan Sato, RN 314-362-1065 firstname.lastname@example.org|
|Principal Investigator: Grant Bochicchio, MD, MPH|
|Principal Investigator:||Grant Bochicchio, MD MPH||Washington University School of Medicine|