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| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date † | April 20, 2007 | ||||||||
| Last Updated Date | January 15, 2009 | ||||||||
| Start Date † | September 2006 | ||||||||
| Current Primary Outcome Measures † |
To prospectively evaluate the reliability of continuous glucose monitors and the advisability of their use in patients with severe trauma and or thermal injury. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00464386 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Continuous Glucose Monitoring (POC) in the ICU | ||||||||
| Official Title † | Continuous Glucose Monitors (CGM) Versus Point-of-Care (POC) Glucometers in the Intensive Care Unit (ICU) | ||||||||
| Brief Summary | The purpose of this study is to prospectively evaluate whether the addition of continuous glucose monitoring to point-of-care (POC) glucometer monitoring improves glucose control. |
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| Detailed Description | Severe burns and traumatic injury can be associated with protracted illness and prolonged ICU course. The beneficial effects of strict serum glucose control in critically ill surgical patients have been demonstrated. Continuous glucose monitors may improve glucose control by providing close to real-time glucose measurements, giving the critical care team the ability to react to trends before hypo- or hyperglycemia is reached. These improvements may decrease the morbidity and mortality associated with severe thermal injury, thereby minimizing hospital stay and recovery. Burned and injured soldiers, airmen, sailors, and marines may return to duty in a more expeditious fashion, or at minimum, enjoy a better quality of life after discharge from the intensive care unit. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition † |
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| Intervention † | Device: Point of Care Glucometer monitor | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | Kerr D. Continuous blood glucose monitoring: detection and prevention of hypoglycaemia. Int J Clin Pract Suppl. 2001 Sep;(123):43-6. Review. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 84 | ||||||||
| Estimated Completion Date | November 2010 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 72 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00464386 | ||||||||
| Responsible Party | Heather Pidcoke, MD, US Army Institute of Surgical Research | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | United States Army Institute of Surgical Research | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | United States Army Institute of Surgical Research | ||||||||
| Verification Date | January 2009 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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