An interventional study of Current UVA intensive care insulin protocol and Current UVA intensive care insulin protocol with "brakes" in Hyperglycemia and Hypoglycemia, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-31.
Sponsored by University of Virginia · Not applicable, Interventional, and Treatment
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:
640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.
This study's planned enrollment of 20 is below the median of 29 across 471 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Age 18 y.o. and above
Exclusion Criteria:
Restrictions on use of other drugs or treatments.
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.
Other: Current UVA intensive care insulin protocol
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.
Other: Current UVA intensive care insulin protocol with "brakes"
Current UVA intensive care insulin protocol used for insulin management for 12 hours
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).
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.
Time frame: Up to 7 days
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)
Time frame: 12 hours
This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Virginia