HypoglycemiaNCT01043042
Identification of Inpatients at Risk for Poor Glycemic Control
An observational study of Hypoglycemia and Hyperglycemia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoglycemia, Hyperglycemia
- How many people
- 33,011 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- age ≥ 18 years
- hospitalized in VUH
Who cannot join
- -length of stay < 24 hours
- pregnant women
- patients receiving palliative/hospice care
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Hospital
Nashville, Tennessee, 37232
About this study
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
- Conditions
- Hypoglycemia, Hyperglycemia
- Being tested
- No interventions will be used in this study
- Keywords
- hypoglycemia among inpatients, hyperglycemia among inpatients
- Medical subject headings
- Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions will be used in this studyOther
No interventions will be used in this study
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients | patients hospitalized at VUH between 4/1/2008 to 10/31/2009 Receives: Other: No interventions will be used in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypoglycemia or hypoglycemia
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Boord, MD MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043042
- Sponsor's protocol ID
- 091507
- Status last verified
- Mar 2017
- First submitted
- 4 Jan 2010
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Inpatients at Risk for Poor Glycemic Control
- ClinicalTrials.gov ID
- NCT01043042
- Acronym / sponsor ID
- 091507
- Conditions
- Hypoglycemia, Hyperglycemia
- Keywords
- hypoglycemia among inpatients, hyperglycemia among inpatients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33,011 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients | – | Other: No interventions will be used in this studypatients hospitalized at VUH between 4/1/2008 to 10/31/2009 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- age ≥ 18 years
- hospitalized in VUH
Key exclusion criteria (3 listed)
- -length of stay < 24 hours
- pregnant women
- patients receiving palliative/hospice care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions will be used in this studyNo interventions will be used in this study | Other | Hospitalized patients |
Primary outcome
hypoglycemia or hypoglycemia
Time frame: during hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Boord, MD MPH principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia and Hyperglycemia, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypoglycemia or hypoglycemia (time frame: during hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.