Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-16 @ 10:22 AM
Study NCT ID:
NCT00655460
Status:
UNKNOWN
Last Update Posted:
2015-02-26
First Post:
2008-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 1
Sponsor:
Intermountain Health Care, Inc.
Organization:
Study Overview
Official Title:
Clinical Process Improvement With A Bedside Computerized Insulin Therapy Protocol For Blood Glucose Control (eProtocol-insulin) in Adult And Pediatric ICU Patients:Further Refinement and Validation of eProtocol-insulin
Status:
UNKNOWN
Status Verified Date:
2008-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Purpose of this study is to:
1. Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients.
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.
1. Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients.
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.
Detailed Description:
This first phase will be a prospective cohort study. We will validate the bedside tool in at least 4 adult and at least 4 pediatric ICUs and if necessary we will modify the bedside tool. The computerized bedside tool will be considered refined if \>90% of the generated instructions are accepted and if the percent of glucose values in the 70-110 mg/dl range are equivalent to our pilot experience rate of 55%, and if the rate of glucose values less than or equal to 40 mg/dl is less than 0.5% of glucose measurements.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HHSN268200425210C | None | None | View |