Clinical Trial on Diabetes Mellitus - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Diabetes Mellitus

Detailed Description

This study is a retrospective cross-sectional study at one institution, where the investigators compared diabetic patients admitted to Medicine Services from March-April 2006 (before CPOE was implemented) to patients admitted from October-November 2007 (one year after CPOE implementation). Capillary blood glucose values, Hemoglobin AIC, diabetes medication profile and demographic data were obtained to compare between groups. The investigators hypothesized that a computer-based protocol that emphasizes basal-bolus and correctional insulin orders and excludes sliding scale, in conjunction with nursing personnel inservicing, improves outcomes.

Study Type

Observational

Enrollment (Actual)

413

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Illinois
  - Chicago, Illinois, United States, 60612
    - John H. Stroger Jr. Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Diabetic patients admitted to Medicine Services

Description

Inclusion Criteria:

Clinical diagnosis of Diabetes Mellitus

Exclusion Criteria:

Admitted to Non-Medicine Hospital Services

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Pre-protocol group Group admitted 1 (one) month before CPOE protocol changes were made
Post-protocol group Group admitted 1 (one) year after CPOE protocol changes were made

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Inpatient Glucose Time Frame: From day of admission to hospital until day of discharge from hospital	Baseline glucose	From day of admission to hospital until day of discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of normoglycemic (70 to 150 mg/dl) patient-days Time Frame: From day of admission to hospital until day of discharge from hospital	Percentage of inpatient days at glucose target	From day of admission to hospital until day of discharge from hospital
Percentage of hyperglycemic patient-days Time Frame: From day of admission to hospital until day of discharge from hospital	Percentage of inpatient days above glucose target	From day of admission to hospital until day of discharge from hospital
Percentage of Patient-days with glucose less than 70 mg/dl Time Frame: From day of admission to hospital until day of discharge from hospital	Percentage of inpatient days below glucose target	From day of admission to hospital until day of discharge from hospital
Percentage of Patients with inpatient or recent (less than 6 months) hemoglobin AIC Time Frame: From day of admission to hospital until day of discharge from hospital	Percentage of patients with recent A1c	From day of admission to hospital until day of discharge from hospital
Length of stay Time Frame: From day of admission to hospital until day of discharge from hospital	Number of days inpatient	From day of admission to hospital until day of discharge from hospital
Distribution of oral hypoglycemic use Time Frame: From day of admission to hospital until day of discharge from hospital	Rate of oral diabetes medication use	From day of admission to hospital until day of discharge from hospital
Distribution of type of insulin therapy used Time Frame: From day of admission to hospital until day of discharge from hospital	Rate of insulin use	From day of admission to hospital until day of discharge from hospital
Percent of patient-days with severe hypoglycemia Time Frame: From day of admission to hospital until day of discharge from hospital	Percentage of patient days with glucose below 55 mg/dL	From day of admission to hospital until day of discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook County Health

Investigators

Principal Investigator: Yannis S Guerra, MD, Rush University Hospital/John H Stroger Jr. Hospital
Study Chair: Krishna Das, MD, John H. Stroger Jr. Hospital
Study Chair: Pete Antonopoulos, MD, John H. Stroger Jr. Hospital
Study Chair: Irene Benson, RN, John H. Stroger Jr. Hospital
Study Chair: Shane Borkowski, MD, John H. Stroger Jr. Hospital
Study Chair: Leon Fogelfeld, MD, John H. Stroger Jr. Hospital
Study Chair: Melanie Gordon, MD, John H. Stroger Jr. Hospital
Study Chair: Betsy Palal, MD, John H. Stroger Jr. Hospital
Study Chair: Joana Witsil, MD, John H. Stroger Jr. Hospital
Study Director: Evelyn Lacuesta, MD, John H. Stroger Jr. Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

July 16, 2008

First Submitted That Met QC Criteria