Computer Decision Support to Achieve Glycemic Control in the ICU (EndoTool)
Primary Purpose
Burns, Hypoglycemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Endo Tool
Sponsored by
About this trial
This is an interventional diagnostic trial for Burns focused on measuring burns, hypoglycemia, hyperglycemia, glucose monitoring
Eligibility Criteria
Inclusion Criteria: 18 years or older military or civilian burns on continuous insulin infusion for 7 days Exclusion Criteria: not expected to receive insulin for 7 days less than 18 years old enrolled in the Continuous Glucose monitoring Study
Sites / Locations
- US Army Institute of Surgical Research
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Time spent in target glucose range of 80-110 mg/dL.
Secondary Outcome Measures
Time to achieve target glucose of 80-110 mg/dL and number of hypoglycemic events less than 80 and 50 mg/dL.
Full Information
NCT ID
NCT00589589
First Posted
December 24, 2007
Last Updated
September 1, 2015
Sponsor
United States Army Institute of Surgical Research
1. Study Identification
Unique Protocol Identification Number
NCT00589589
Brief Title
Computer Decision Support to Achieve Glycemic Control in the ICU
Acronym
EndoTool
Official Title
Computer Decision Support to Achieve Glycemic Control in the ICU
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Army Institute of Surgical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is intended to fill the knowledge gap regarding the burn population with research that achieves scientific merit. we will determine the effectiveness of the computer decision support system (CDSS) to facilitate glucose management in the critically ill burn patient.
The EndoTool™ computer decision support system will achieve glycemic control (defined as 80-110 mg/dL) in a shorter time, reduce glycemic excursion outside of target range, and reduce incidence of hypoglycemia (blood glucose less than 50 mg/dL) in the critically ill burn patient compared to the standard of care USAISR insulin titration protocol (Appendix A).
Detailed Description
This is a prospective, paired, randomized, cross-over design, with two groups: current standard of care using the USAISR Burn Center insulin titration nomogram (Appendix A) and insulin management using EndoTool™ (MD Scientific, LLC) decision support software. Patients will thus serve as their own controls.
Upon admission to the burn ICU, patients expected to require continuous insulin infusion for a minimum of 7 days will be placed on EndoTool™ CDSS for the first 24 hours of glycemic management. At the 24 hour mark the patients will be randomly assigned to either the CDSS or standard of care group in pairs. Thus, the first subject will be randomized to a group and the second subject will be placed in the alternate group. This method will ensure equal numbers of patients are enrolled in each group to eliminate bias of timing of intervention due to the effect of increasing insulin resistance over time demonstrated in the burn population (Pidcoke, unpublished, USAISR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Hypoglycemia
Keywords
burns, hypoglycemia, hyperglycemia, glucose monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Endo Tool
Other Intervention Name(s)
Computer Software for glucose control
Intervention Description
Computer tool to help achieve glucose control
Primary Outcome Measure Information:
Title
Time spent in target glucose range of 80-110 mg/dL.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Time to achieve target glucose of 80-110 mg/dL and number of hypoglycemic events less than 80 and 50 mg/dL.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
military or civilian burns on continuous insulin infusion for 7 days
Exclusion Criteria:
not expected to receive insulin for 7 days
less than 18 years old
enrolled in the Continuous Glucose monitoring Study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Mann, RN, MSN
Organizational Affiliation
United States Army Institute of Surgical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Army Institute of Surgical Research
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12576937
Citation
Van den Berghe G, Wouters PJ, Bouillon R, Weekers F, Verwaest C, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P. Outcome benefit of intensive insulin therapy in the critically ill: Insulin dose versus glycemic control. Crit Care Med. 2003 Feb;31(2):359-66. doi: 10.1097/01.CCM.0000045568.12881.10.
Results Reference
background
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Computer Decision Support to Achieve Glycemic Control in the ICU
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