NCT00412347

Brief Summary

Increasing evidence from clinical studies in Intensive Care Unit (ICU) settings indicates that insulin infusion can improve outcome measures for patients with hyperglycemia (high blood sugar) independent of a previous diagnosis of diabetes mellitus. This improvement in health could also apply to patients that have high blood sugars in various other non-critical care areas of the hospital as well. However, the data that shows improvement in health outcomes has been collected from wards that have a lower patient to provider and patient to nurse ratio, resulting in the ability for a much tighter control of the insulin infusion. We hypothesize that tight blood glucose control will provide the same benefits for patients in non-intensive care units settings but that these protocols may lead to a higher incidence of hypoglycemia (low blood sugar) and potentially to adverse outcomes in patients. This study aims to determine the clinical outcome of patients treated with insulin infusion as well as the rate of hypoglycemic episodes in non-intensive areas. We will conduct a chart review of patients treated with insulin infusions in non-critical wards at Emory University Hospital during the period of 7/1/04 to 6/30/05. Medical records of all patients treated with intravenous insulin infusion protocols will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2006

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

First QC Date

December 14, 2006

Last Update Submit

February 7, 2014

Conditions

Keywords

hyperglycemiadiabetesinsulin driphypoglycemiageneral wards

Interventions

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of hospitalized adult subjects in a teaching institution.

You may qualify if:

  • All subjects over 18 years of age that received intravenous insulin treatment on general medical and surgical wards at Emory University Hospital during the period of 7/1/2004 to 6/30/2005

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Atlanta, Georgia, 30324, United States

Location

Related Publications (1)

  • Smiley D, Rhee M, Peng L, Roediger L, Mulligan P, Satterwhite L, Bowen P, Umpierrez GE. Safety and efficacy of continuous insulin infusion in noncritical care settings. J Hosp Med. 2010 Apr;5(4):212-7. doi: 10.1002/jhm.646.

MeSH Terms

Conditions

HyperglycemiaDiabetes MellitusHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Guillermo Umpierrez, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2006

First Posted

December 18, 2006

Study Start

August 1, 2006

Study Completion

December 1, 2006

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations