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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
| University of Texas | OTHER |
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The investigators believe that there remains a gap in implementing insulin infusions in critically ill patients to maximize the benefit and minimize adverse events like episodes of hypoglycemia. Based on the published experience with Continuous Glucose Monitor (CGM), the investigators believe that it is safe to use in critically ill patients. Furthermore, the investigators believe that in combination with a protocol with low risk for hypoglycemia at baseline, that CGM can eliminate this risk fully.
In this study the investigators will:
The principle focus of this project is to collect pilot data for a larger study that will test the hypothesis that continuous glucose monitoring (CGM) is safe in critically ill patients and provides important information that can prevent hypoglycemia. This study will determine the feasibility of CGM along with the current UVA intensive care insulin protocol in critically ill hyperglycemic patients as well as to provide some information that may help estimate differences necessary to power future studies.
The following statements summarize the background for this protocol:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current UVA intensive care insulin protocol without brakes | Other | Studies the safety and feasibility of the continuous glucose monitor in 10 critically ill patients for 7 days and uses the current UVA intensive care insulin for insulin management for 12 hours. |
|
| Current UVA intensive care insulin protocol with brakes | Active Comparator | Studies the safety and feasibility of the continuous glucose monitor in 10 critically ill patients for 7 days. Uses the current UVA intensive care insulin protocol for insulin management for 12 hours with the addition of "brakes" that reduce insulin administration based on continuous glucose monitoring data between hourly reference glucose data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Current UVA intensive care insulin protocol | Other | Current UVA intensive care insulin protocol used for insulin management for 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and feasibility of the Continuous Glucose Monitor in critically ill hyperglycemic patients for up to 7 days. | To show that Continuous Glucose Monitor sensors are safe in critically ill patients with a low (<1%) rate of adverse events. | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The utility of Continuous Glucose Monitor-driven "brakes" to prevent episodes of hypoglycemia using the current UVA intensive care insulin Protocol | Continuous Glucose Monitor can prevent episodes of hypoglycemia (defined as a blood glucose less than 70mg/dl) and severe hypoglycemia (defined as a blood glucose less than 50 mg/dl) | 12 hours |
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Inclusion Criteria:
Age 18 y.o. and above
Patient will require an insulin infusion or is currently prescribed an insulin infusion during the ICU admission.
Exclusion Criteria:
Restrictions on use of other drugs or treatments.
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| Name | Affiliation | Role |
|---|---|---|
| Stacey Anderson, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia, Center for Diabetes Technology | Charlottesville | Virginia | 22908 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 3, 2015 | |
| Reset | Jul 30, 2015 | |
| Release | Jul 21, 2016 | |
| Reset | Sep 1, 2016 | |
| Release | Oct 28, 2017 | |
| Reset | Aug 3, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 3, 2015 | Jul 30, 2015 | |||
| Jul 21, 2016 |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Current UVA intensive care insulin protocol with "brakes" | Other | Current UVA intensive care insulin protocol for insulin management with the addition of "brakes" which reduces insulin administration based on continuous glucose monitoring data between hourly reference glucose data to reduce episodes of hypoglycemia (blood glucose <70 mg/dl)and severe hypoglycemia (blood glucose<50 mg/dl). |
|
| Sep 1, 2016 |
| Oct 28, 2017 | Aug 3, 2018 |