GIDE: Glucose Time-In-Range Development Evaluation

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03670017
• Collaborator: OptiScan Biomedical Corporation (Industry)
• Enrollment: 68
• Location: 1
• Arm: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: N/A
• 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: Sep 6, 2018
• Actual Primary Completion Date: Sep 4, 2020
• Actual Study Completion Date: Sep 4, 2020

Arms and Interventions

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

1. Glucose Time-in-range (TIR) [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. [Up to 72 hours]

   Evaluation of the amount of time required for a patient to have in range glucose values

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine
• OptiScan Biomedical Corporation

Investigators

• Principal Investigator: Grant Bochicchio, MD MPH, Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol - Oct 8, 2018

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03670017
• Other Study ID Numbers: GIDE Study
• First Posted: Sep 13, 2018
• Last Update Posted: Oct 19, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

Participant Flow

Arm/Group Title	Time In Range During OptiScanner Connection
Arm/Group Description	Participants will be connected to the OptiScanner 5000 for up to 72 hours. 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.
Period Title: Overall Study
STARTED	68
COMPLETED	50
NOT COMPLETED	18

Baseline Characteristics

Arm/Group Title	Time In Range During OptiScanner Connection
Arm/Group Description	Participants will be connected to the OptiScanner 5000 for up to 72 hours. 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.
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	25 50%
>=65 years	25 50%
Sex: Female, Male (Count of Participants)
Female	25 50%
Male	25 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 14%
White	41 82%
More than one race	0 0%
Unknown or Not Reported	2 4%

Outcome Measures

1. Primary Outcome

Title	Glucose Time-in-range (TIR)
Description	Glucose time in range will be defined by participant's clinical care defined target glucose range
Time Frame	Up to 72 hours

Outcome Measure Data

Analysis Population Description

The percentage of time in range is all that is available. The company declared bankruptcy due to COVID 19. Raw data is no longer available.

Arm/Group Title	Time In Range During OptiScanner Connection
Arm/Group Description	Participants will be connected to the OptiScanner 5000 for up to 72 hours. 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.
Measure Participants	50
Number [percentage of time in range]	55

2. Secondary Outcome

Title	Assessment of the Time it Takes the Patient to Achieve in Range Glucose Values While Connected to the OptiScanner.
Description	Evaluation of the amount of time required for a patient to have in range glucose values
Time Frame	Up to 72 hours

Outcome Measure Data

Analysis Population Description

The sponsor went out of business prior to completing the analysis for this endpoint therefore the information is not available.

Arm/Group Title	Time In Range During OptiScanner Connection
Arm/Group Description	Participants will be connected to the OptiScanner 5000 for up to 72 hours. 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.
Measure Participants	0

Adverse Events

Time Frame	72 hours
Arm/Group Title	Time In Range During OptiScanner Connection
Arm/Group Description	Participants will be connected to the OptiScanner 5000 for up to 72 hours. 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.
All Cause Mortality
	Time In Range During OptiScanner Connection
	Affected / at Risk (%)	# Events
Total	6/50 (12%)
Serious Adverse Events
	Time In Range During OptiScanner Connection
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Other (Not Including Serious) Adverse Events
	Time In Range During OptiScanner Connection
	Affected / at Risk (%)	# Events
Total	0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.