Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2
NCT ID: NCT00654797
Last Updated: 2015-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2007-09-30
2018-12-31
Brief Summary
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1. Introduce the refined, validated, and safe computerized bedside decision support tool for blood glucose management in critically ill adult and pediatric ICU patients that was studied in Phase 1 into a second group of naïve ICUs, none of which participated in eProtocol-insulin development, refinement or validation
2. Monitor how often low blood sugar levels occur during use of the bedside tool.
3. Determine how the computerized tool effects the workload of the ICU nurses.
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Detailed Description
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This second phase will be a prospective cohort study. We will determine the feasibility of distributing eProtocol-insulin and will further validate eProtocol-insulin in \>4 adult and \>4 pediatric ICUs. If necessary we will modify eProtocol-insulin with an iterative refinement process, with Institutional Review Board (IRB) and independent Data and Safety Monitoring Board (DSMB) oversight. eProtocol-insulin will be considered refined if \>90% of the instructions are accepted and if the percent of glucose values between 70 and 110 mg/dl (3.9-6.1 mMol/L) are equivalent to our Phase-1 refinement and validation experience of 46%%, and if the rate of glucose values \< 40 mg/dl (2.2 mMol/l) is less than 0.5% of glucose measurements.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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eProtocol
glucose control with computer generated recommendations
Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose.
Interventions
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glucose control with computer generated recommendations
Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose.
Eligibility Criteria
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Inclusion Criteria
2. Adult ICUs: Proposed indications by clinicians in participating ICUs for glucose control in participating adult ICUs include critically ill patients with an anticipated ICU length of stay of 3 or more days.
Exclusion Criteria
2. Age less than one month
3. Inborn errors of metabolism that the clinician suspects will affect glucose homeostasis
4. Acute or chronic liver disease with any documented episode of blood or plasma glucose \<60 mg/dl within the 24 hours prior to study entry
5. Diabetic Ketoacidosis (critically ill patients with insulin dependent diabetes not in ketoacidosis will be eligible if attending physicians intend to use intravenous insulin as part of ordinary care)
6. Severe chronic liver disease (Child-Pugh score \>10)
1 Month
ALL
No
Sponsors
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Intermountain Health Care, Inc.
OTHER
Responsible Party
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Principal Investigators
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Alan H Morris, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Medical Center, Murray, Utah
Locations
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Childrens Hospital Centeral California
Madera, California, United States
Childrens Hospital of Minnesota - St. Paul
Saint Paul, Minnesota, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cornell University Medical College
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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HHSN268200425210C
Identifier Type: -
Identifier Source: secondary_id
N01-HC-45210-2
Identifier Type: -
Identifier Source: org_study_id
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