NCT00718198

Brief Summary

Retrospective cross-sectional study measuring the impact of a computer=based insulin correction protocol and nursing inservicing on diabetes outcomes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
413

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
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

July 16, 2008

Last Update Submit

November 22, 2023

Conditions

Keywords

InpatientComputer Physician Order EntryDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Mean Inpatient Glucose

    Baseline glucose

    From day of admission to hospital until day of discharge from hospital

Secondary Outcomes (8)

  • Percentage of normoglycemic (70 to 150 mg/dl) patient-days

    From day of admission to hospital until day of discharge from hospital

  • Percentage of hyperglycemic patient-days

    From day of admission to hospital until day of discharge from hospital

  • Percentage of Patient-days with glucose less than 70 mg/dl

    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

    From day of admission to hospital until day of discharge from hospital

  • Length of stay

    From day of admission to hospital until day of discharge from hospital

  • +3 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

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

Diabetic patients admitted to Medicine Services

You may qualify if:

  • Clinical diagnosis of Diabetes Mellitus

You may not qualify if:

  • Admitted to Non-Medicine Hospital Services

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 Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Yannis S Guerra, MD

    Rush University Hospital/John H Stroger Jr. Hospital

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR
  • Evelyn Lacuesta, MD

    John H. Stroger Jr. Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 18, 2008

Study Start

March 1, 2006

Primary Completion

December 1, 2007

Study Completion

June 1, 2008

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations