Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 2

Intermountain Health Care, Inc.

Status and phase: Unknown; Phase 2

Conditions: Hyperglycemia; Critically Ill

Treatments: Procedure: glucose control with computer generated recommendations

Study type: Interventional

Funder types: Other

Identifiers

NCT00654797

HHSN268200425210C

N01-HC-45210-2

Details and patient eligibility

About

The Purpose of this study is to:

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1+ month old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pediatric ICU: Proposed indications by pediatric clinicians at participating ICUs for glucose control in their ICUs would include patients who require mechanical ventilation for greater than 24 hours and/or require a vasoactive infusion (e.g. dopamine >3 mg/kg/min, dobutamine, epinephrine, or vasopressin).
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

1. Pregnancy (negative pregnancy test required for females of child-bearing age)
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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

eProtocol

Experimental group

Treatment:

Procedure: glucose control with computer generated recommendations