Diabetes MellitusNCT00842010
Characteristics of Non Diabetic Hyperglycemic Inpatients
An observational study of Diabetes Mellitus, run by Cook County Health at 1 site in United States.
Trial summary
Retrospective nested non-matched case control study comparing patients by glycemic status Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2008
- 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: Nested sample obtained from patients admitted to John H. Stroger Jr. Hospital from March-April 2006 and in October 2007.
Who may be able to join
- Admitted to John H. Stroger Jr. Hospital
- Admitted to Internal Medicine Service from March-April 2006 and in October 2007
Who cannot join
- Transfer from any intensive care unit (medical or surgical)
Trial locations and contacts
1 site in 1 country.
United States1 site
John H. Stroger Jr. Hospital
Chicago, Illinois, 60612
About this study
Official title: Hyperglycemic Non Diabetic (HND) Hospital Patients: Are They Different From Diabetic Hyperglycemic and Non-Hyperglycemic Non-Diabetic(NHND) Patients?
Retrospective nested non-matched case control study comparing patients by glycemic status
Read the detailed description
This retrospective nested non-matched case control study compared patients directly admitted to the General Medicine Wards, not transferred from ICU with
- hyperglycemia on admission but no previous diagnosis of diabetes
- diabetic hyperglycemic patients
- non hyperglycemic non diabetic patients from the same nested population.
The investigators' hypothesis is that the clinical characteristics and endpoints of the non diabetic hyperglycemics should be similar to the diabetic population and different from the non diabetic non hyperglycemic population.
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Inpatient, Hospital, Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Hospital stay measured in days
Measured: Measured 24 hours after patient is discharged. From day 1 of admission until day of discharge
Inpatient Mortality
Mortality measured in number of events
Measured: From day 1 of admission until day of discharge
Secondary outcomes (4)
Frequency of SIRS on admission
Number of SIRS
Measured: Measures obtained 24 hours after patient is discharged. Clinical data obtained on day 1 of admission
Frequency of inpatient infection
Measured in number of events
Measured: From day 1 of admission until day of discharge
Rate of use of intravenous glucose drip
Rate of use
Measured: From day 1 of admission until day of discharge
Frequency of steroid use
Frequency of use
Measured: From day 1 of admission until day of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startMar 2006
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yannis Guerra, Cook County Health
- Investigators
- Evelyn Lacuesta, MD, Principal investigator, John H. Stroger Jr. HospitalJyothsna Palla, MD, Study chair, John H. Stroger Jr. HospitalYannis Guerra, MD, Study chair, Rush University Hospital, John H. Stroger Jr. Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842010
- Sponsor's protocol ID
- 06-063
- Status last verified
- Sep 2023
- First submitted
- 11 Feb 2009
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperglycemic Non Diabetic (HND) Hospital Patients: Are They Different From Diabetic Hyperglycemic and Non-Hyperglycemic Non-Diabetic(NHND) Patients?
- ClinicalTrials.gov ID
- NCT00842010
- Acronym / sponsor ID
- 06-063
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Inpatient, Hospital, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- Mar 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Feb 2009 (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.
Retrospective nested non-matched case control study comparing patients by glycemic status
Detailed description
This retrospective nested non-matched case control study compared patients directly admitted to the General Medicine Wards, not transferred from ICU with
- hyperglycemia on admission but no previous diagnosis of diabetes
- diabetic hyperglycemic patients
- non hyperglycemic non diabetic patients from the same nested population.
The investigators' hypothesis is that the clinical characteristics and endpoints of the non diabetic hyperglycemics should be similar to the diabetic population and different from the non diabetic non hyperglycemic population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Nested sample obtained from patients admitted to John H. Stroger Jr. Hospital from March-April 2006 and in October 2007.
Key inclusion criteria (2 listed)
- Admitted to John H. Stroger Jr. Hospital
- Admitted to Internal Medicine Service from March-April 2006 and in October 2007
Key exclusion criteria (1 listed)
- Transfer from any intensive care unit (medical or surgical)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay
Time frame: Measured 24 hours after patient is discharged. From day 1 of admission until day of discharge
Hospital stay measured in days
Inpatient Mortality
Time frame: From day 1 of admission until day of discharge
Mortality measured in number of events
4 secondary outcomes
Frequency of SIRS on admission
Time frame: Measures obtained 24 hours after patient is discharged. Clinical data obtained on day 1 of admission
Frequency of inpatient infection
Time frame: From day 1 of admission until day of discharge
Rate of use of intravenous glucose drip
Time frame: From day 1 of admission until day of discharge
Frequency of steroid use
Time frame: From day 1 of admission until day of discharge
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 28 Sep 2023.
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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.
Evelyn Lacuesta, MD principal investigator
John H. Stroger Jr. Hospital
Jyothsna Palla, MD study chair
John H. Stroger Jr. Hospital
Yannis Guerra, MD study chair
Rush University Hospital, John H. Stroger Jr. Hospital
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 Diabetes Mellitus, run by Cook County Health 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 1 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 28 Sep 2023. 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?
Length of stay (time frame: Measured 24 hours after patient is discharged. From day 1 of admission until day of discharge). The study lists 2 primary outcomes in all. 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 28 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.