NCT01043042

Brief Summary

Both hypoglycemia and hyperglycemia can be detrimental to hospitalized patients. However, it is not clear which patients are more likely to develop significant problems with hypoglycemia or severe hyperglycemia in the hospital. Our hypothesis is that we will be able to identify risk factors present at admission that identify patients at greater risk of poor inpatient glycemic control

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33,011

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 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

January 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

4.7 years

First QC Date

January 4, 2010

Last Update Submit

March 30, 2017

Conditions

HypoglycemiaHyperglycemia

Keywords

hypoglycemia among inpatientshyperglycemia among inpatients

Outcome Measures

Primary Outcomes (1)

  • hypoglycemia or hypoglycemia

    during hospitalization

Study Arms (1)

Hospitalized patients

patients hospitalized at VUH between 4/1/2008 to 10/31/2009

Other: No interventions will be used in this study

Interventions

No interventions will be used in this studyOTHER

No interventions will be used in this study

Hospitalized patients

Eligibility Criteria

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

Candidates for inclusion will include all adult (age ≥ 18 years) patients admitted to Vanderbilt University Medical Center from 04/01/2008 to 10/31/2009. Patients will be excluded if they were pregnant at the time of admission or had length of stay \< 24 hours.

You may qualify if:

  • age ≥ 18 years
  • hospitalized in VUH

You may not qualify if:

  • length of stay \< 24 hours
  • pregnant women
  • patients receiving palliative/hospice care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Hospital

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

HypoglycemiaHyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jeffrey Boord, MD MPH

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 6, 2010

Study Start

January 1, 2010

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

US(1)