Identification of Inpatients at Risk for Poor Glycemic Co... | NCT01043042

Studies
Identification of Inpatients at Risk for Poor Glycemic Control

NCT01043042

Sponsor

Vanderbilt University Medical Center

Status

Completed

Last Update Posted

Apr 4, 2017Actual

Enrollment

33,011Actual

Phase

Not provided

Conditions

Hypoglycemia
Hyperglycemia

Interventions

No interventions will be used in this study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jan 4, 2010

First Submission Date that Met QC Criteria

Jan 5, 2010

First Posted Date

Jan 6, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2017

Last Update Posted Date

Apr 4, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33,011Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hospitalized patients		patients hospitalized at VUH between 4/1/2008 to 10/31/2009	Other: No interventions will be used in this study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No interventions will be used in this study	Other	No interventions will be used in this study	Hospitalized patients

Measure	Description	Time Frame
hypoglycemia or hypoglycemia		during hospitalization

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥ 18 years
hospitalized in VUH

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Boord, MD MPH	Vanderbilt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Hospital		Nashville	Tennessee	37232	United States

Condition Browse Module

MeSH Terms

ID	Term
D007003	Hypoglycemia
D006943	Hyperglycemia

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided