A Phase 2 interventional study of glucose control with computer generated recommendations in Critically Ill and Hyperglycemia, sponsored by Intermountain Health Care, Inc.. Status unknown at 10 sites in United States. Open to participants aged 1 Month and older. Per ClinicalTrials.gov, last updated 2015-02-26.
Sponsored by Intermountain Health Care, Inc. · Phase 2, Interventional, and Treatment
The Purpose of this study is to:
In the current second phase of this project (Phase-2), we will introduce the refined, validated, and safe eProtocol-insulin into a second group of naïve ICUs, none of which participated in eProtocol-insulin development, refinement or validation. Our primary goal in this second phase is to determine the feasibility of exporting this tool to naïve ICU environments. In this second phase we will also compare the effects of the eProtocol-insulin and ordinary care approaches to glucose control on the bedside nurse's experience.
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.
699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.
This study's planned enrollment of 200 is above the median of 46 across 521 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: 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.
The primary outcome variable for feasibility during Phase-2 will be the acceptability of the eProtocol-insulin instructions (compliance of bedside clinicians with instructions). Proportion of glucose values < 40 mg/dl.
Time frame: 1 year
Proportion of glucose determinations between 70 and 110 mg/dl (3.9-6.1 mMol/L) (efficacy)
Time frame: 1 year
Time to reach the 80-110 mg/dl target
Time frame: 1 year
Nursing perception of workload in comparison to ordinary care (efficacy and feasibility)
Time frame: 1 year
Proportion of glucose values 41-60 mg/dl
Time frame: 1 year
This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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Intermountain Health Care, Inc.