Dysglycemia Clinical Trial
— GIDEOfficial title:
GIDE - Glucose Time-In-Range Development Evaluation
Verified date | September 2021 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 68 |
Est. completion date | September 4, 2020 |
Est. primary completion date | September 4, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Barnes Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | OptiScan Biomedical Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glucose Time-in-range (TIR) | Glucose time in range will be defined by participant's clinical care defined target glucose range | Up to 72 hours | |
Secondary | Assessment of the Time it Takes the Patient to Achieve in Range Glucose Values While Connected to the OptiScanner. | Evaluation of the amount of time required for a patient to have in range glucose values | Up to 72 hours |
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