Glucose Time-In-Range Development Evaluation

NCT03670017 | Terminated Results FDA Device

• 1 other identifier: GIDE Study
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

ICU; Dysglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of the Time it Takes the Patient to Achieve in Range Glucose Values While Connected to the OptiScanner.

  Up to 72 hours

Study Arms (1)

Time In Range during OptiScanner Connection

OTHER

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

Device: OptiScanner® 5000 Glucose Monitoring System

Interventions

OptiScanner® 5000 Glucose Monitoring System 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.

Time In Range during OptiScanner Connection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent by the participant or his/her legally authorized representative;
• At least 18 years old;
• Admitted to a Surgical Intensive Care Unit (SICU) or planned admission to a Surgical ICU at time of screening
• Expected SICU stay of at least 48 hours at the time of enrollment
• 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.

You may not qualify if:

• 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.
• Patients undergoing peritoneal dialysis within the past week.
• Patients actively receiving intravenous immunoglobulin therapy.
• Patients receiving intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer.
• Patients following the administration of a D-Xylose absorption test \< 12 hours
• Patients being treated with Sodium Thiosulfate
• Patients being receiving IV glycerol
• 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.
• Hct \<15% within 24 hours of screening visit

Sponsors & Collaborators

• Washington University School of Medicine: lead
• OptiScan Biomedical Corporation: collaborator

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Results Point of Contact

• Title: Grant Bochicchio, Harry Edison Professor of Surgery, Chief of Acute and Critical Care Surgery
• Organization: Washington University School of Medicine

gbochicchio@wustl.edu

314-362-9347

Study Officials

• Grant Bochicchio, MD MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: September 6, 2018
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: October 19, 2021
• Results First Posted: October 19, 2021

Record last verified: 2021-09

Locations

US (1)