NCT00842010

Brief Summary

Retrospective nested non-matched case control study comparing patients by glycemic status

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Typical duration 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

March 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

February 11, 2009

Last Update Submit

September 25, 2023

Conditions

Keywords

DiabetesInpatientHospitalHyperglycemia

Outcome Measures

Primary Outcomes (2)

  • Length of stay

    Hospital stay measured in days

    Measured 24 hours after patient is discharged. From day 1 of admission until day of discharge

  • Inpatient Mortality

    Mortality measured in number of events

    From day 1 of admission until day of discharge

Secondary Outcomes (4)

  • Frequency of SIRS on admission

    Measures obtained 24 hours after patient is discharged. Clinical data obtained on day 1 of admission

  • Frequency of inpatient infection

    From day 1 of admission until day of discharge

  • Rate of use of intravenous glucose drip

    From day 1 of admission until day of discharge

  • Frequency of steroid use

    From day 1 of admission until day of discharge

Study Arms (3)

Hyperglycemic without previous DM diagnosis

Patients with hyperglycemia, without previous diagnosis of diabetes

Previous diagnosis of DM

Patients that have previous diagnosis of Diabetes Mellitus

No previous DM diagnosis and no hyperglycemia

Patient with NO previous diagnosis of diabetes, and no hyperglycemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nested sample obtained from patients admitted to John H. Stroger Jr. Hospital from March-April 2006 and in October 2007.

You may qualify if:

  • Admitted to John H. Stroger Jr. Hospital
  • Admitted to Internal Medicine Service from March-April 2006 and in October 2007

You may not qualify if:

  • Transfer from any intensive care unit (medical or surgical)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John H. Stroger Jr. Hospital

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Evelyn Lacuesta, MD

    John H. Stroger Jr. Hospital

    PRINCIPAL INVESTIGATOR
  • Jyothsna Palla, MD

    John H. Stroger Jr. Hospital

    STUDY CHAIR
  • Yannis Guerra, MD

    Rush University Hospital, John H. Stroger Jr. Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2008

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations