HyperglycemiaNCT00412347
Insulin Infusion in the Hospital Wards
An observational study of Hyperglycemia, run by Emory University at 1 site in United States.
Trial summary
Increasing evidence from clinical studies in Intensive Care Unit (ICU) settings indicates that insulin infusion can improve outcome measures for patients with hyperglycemia (high blood sugar) independent of a previous diagnosis of diabetes mellitus. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Insulin Drip Therapy
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2006
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort of hospitalized adult subjects in a teaching institution.
Who may be able to join
- All subjects over 18 years of age that received intravenous insulin treatment on general medical and surgical wards at Emory University Hospital during the period of 7/1/2004 to 6/30/2005
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Insulin Infusion and Outcomes for Non-Critical Wards
Increasing evidence from clinical studies in Intensive Care Unit (ICU) settings indicates that insulin infusion can improve outcome measures for patients with hyperglycemia (high blood sugar) independent of a previous diagnosis of diabetes mellitus. This improvement in health could also apply to patients that have high blood sugars in various other non-critical care areas of the hospital as well. However, the data that shows improvement in health outcomes has been collected from wards that have a lower patient to provider and patient to nurse ratio, resulting in the ability for a much tighter control of the insulin infusion. We hypothesize that tight blood glucose control will provide the same benefits for patients in non-intensive care units settings but that these protocols may lead to a higher incidence of hypoglycemia (low blood sugar) and potentially to adverse outcomes in patients.
This study aims to determine the clinical outcome of patients treated with insulin infusion as well as the rate of hypoglycemic episodes in non-intensive areas. We will conduct a chart review of patients treated with insulin infusions in non-critical wards at Emory University Hospital during the period of 7/1/04 to 6/30/05. Medical records of all patients treated with intravenous insulin infusion protocols will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.
- Conditions
- Hyperglycemia
- Being tested
- Insulin Drip Therapy
- Keywords
- hyperglycemia, diabetes, insulin drip, hypoglycemia, general wards
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Drip TherapyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2006 (estimated)
- Study startAug 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412347
- Sponsor's protocol ID
- 1203-2005
- Other IDs
- 1203-2005
- Status last verified
- Feb 2014
- First submitted
- 14 Dec 2006
- Last updated
- 11 Feb 2014
- Results posted
- No
Publications
Smiley D, Rhee M, Peng L, Roediger L, Mulligan P, Satterwhite L, Bowen P, Umpierrez GE. Safety and efficacy of continuous insulin infusion in noncritical care settings. J Hosp Med. 2010 Apr;5(4):212-7. doi: 10.1002/jhm.646.
PubMed 20394026
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Infusion and Outcomes for Non-Critical Wards
- ClinicalTrials.gov ID
- NCT00412347
- Acronym / sponsor ID
- 1203-2005
- Conditions
- Hyperglycemia
- Keywords
- hyperglycemia, diabetes, insulin drip, hypoglycemia, general wards
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Dec 2006
- First posted
- 18 Dec 2006 (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.
Increasing evidence from clinical studies in Intensive Care Unit (ICU) settings indicates that insulin infusion can improve outcome measures for patients with hyperglycemia (high blood sugar) independent of a previous diagnosis of diabetes mellitus. This improvement in health could also apply to patients that have high blood sugars in various other non-critical care areas of the hospital as well. However, the data that shows improvement in health outcomes has been collected from wards that have a lower patient to provider and patient to nurse ratio, resulting in the ability for a much tighter control of the insulin infusion. We hypothesize that tight blood glucose control will provide the same benefits for patients in non-intensive care units settings but that these protocols may lead to a higher incidence of hypoglycemia (low blood sugar) and potentially to adverse outcomes in patients.
This study aims to determine the clinical outcome of patients treated with insulin infusion as well as the rate of hypoglycemic episodes in non-intensive areas. We will conduct a chart review of patients treated with insulin infusions in non-critical wards at Emory University Hospital during the period of 7/1/04 to 6/30/05. Medical records of all patients treated with intravenous insulin infusion protocols will be analyzed. Data on demographics, laboratory values, mortality rate, rate of hypoglycemic events, length of stay, as well as disposition at discharge will be analyzed.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort of hospitalized adult subjects in a teaching institution.
Key inclusion criteria (1 listed)
- All subjects over 18 years of age that received intravenous insulin treatment on general medical and surgical wards at Emory University Hospital during the period of 7/1/2004 to 6/30/2005
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Insulin Drip Therapy | Drug | – |
Primary outcome
Not reported in the source record.
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 11 Feb 2014.
- Derived from this study: PubMed 20394026Smiley D, Rhee M, Peng L, Roediger L, Mulligan P, Satterwhite L, Bowen P, Umpierrez GE. Safety and efficacy of continuous insulin infusion in noncritical care settings. J Hosp Med. 2010 Apr;5(4):212-7. doi: 10.1002/jhm.646.
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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.
Guillermo Umpierrez, MD principal investigator
Emory 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 Hyperglycemia, run by Emory University 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 1 inclusion and 0 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 11 Feb 2014. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00412347, which also lists 1 linked publication.
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 11 Feb 2014.