DiabetesNCT00302874
In-Hospital Hyperglycemia: Effects of Treatment on Glycemic Control and Clinical Outcome
A study testing Implementation of a protocol for treatment of hyperglycemia in people with Diabetes and Hyperglycemia, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
To improve glycemic control of inpatients admitted to the internal medicine wards, the researchers generated a protocol based on intensive insulin treatment for use in all inpatients with hyperglycemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Hyperglycemia
- What is being tested?
- Implementation of a protocol for treatment of hyperglycemia
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2003to Oct 2004
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to the internal medicine ward with hyperglycemia
Who cannot join
- Patients admitted due to hypoglycemia, hyperosmolar state, and ketoacidosis
Trial locations and contacts
1 site in 1 country.
About this study
To improve glycemic control of inpatients admitted to the internal medicine wards, the researchers generated a protocol based on intensive insulin treatment for use in all inpatients with hyperglycemia.
The researchers hypothesize that intensive insulin treatment will improve the glycemic control and the outcome of hospitalized patients.
Read more
Study Information:
- All patients with a history of diabetes admitted to the internal medicine ward were enrolled in the study.
- At baseline, demographic and clinical information were obtained, including information necessary to determine the severity of the illness. Venous capillary blood glucose levels were checked 4 times a day by glucometer.
- During the pre-intervention period, patients were treated according to the common practice in the hospital without any intervention. The study team collected the baseline data on the glycemic control and treatment of patients admitted with hyperglycemia.
- During the intervention period, the study team visited the ward daily and guided the medical staff as to the use of the treatment protocol.
- During the post-intervention period, the study team collected the data without active intervention in the implementation of the protocol.
- Data was collected on the mode of treatment and glycemic control of all hyperglycemic patients throughout the study. The incidence of hypoglycemia, complications (myocardial infarction, stroke, infections), mortality, transfer to intensive care unit (ICU), length of hospitalization, and disposition at discharge were noted.
- Conditions
- Diabetes, Hyperglycemia
- Being tested
- Implementation of a protocol for treatment of hyperglycemia
- Keywords
- diabetes, hyperglycemia, hospital, medicine ward
- 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.
Implementation of a protocol for treatment of hyperglycemiaBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean blood glucose during hospitalization
Secondary outcomes (5)
Hypoglycemic events
Length of in-hospital stay
Infections
Complications (myocardial infarction, stroke)
Disposition at discharge (home, nursing home)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startFeb 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Gil Leibowitz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302874
- Sponsor's protocol ID
- gil362-HMO-CTIL
- Status last verified
- Oct 2002
- First submitted
- 14 Mar 2006
- Last updated
- 26 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Hospital Hyperglycemia: Effects of Treatment on Glycemic Control and Clinical Outcome
- ClinicalTrials.gov ID
- NCT00302874
- Acronym / sponsor ID
- gil362-HMO-CTIL
- Conditions
- Diabetes, Hyperglycemia
- Keywords
- diabetes, hyperglycemia, hospital, medicine ward
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2003
- Study completion
- Oct 2004
- First posted
- 15 Mar 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.
To improve glycemic control of inpatients admitted to the internal medicine wards, the researchers generated a protocol based on intensive insulin treatment for use in all inpatients with hyperglycemia.
The researchers hypothesize that intensive insulin treatment will improve the glycemic control and the outcome of hospitalized patients.
Study Information:
- All patients with a history of diabetes admitted to the internal medicine ward were enrolled in the study.
- At baseline, demographic and clinical information were obtained, including information necessary to determine the severity of the illness. Venous capillary blood glucose levels were checked 4 times a day by glucometer.
- During the pre-intervention period, patients were treated according to the common practice in the hospital without any intervention. The study team collected the baseline data on the glycemic control and treatment of patients admitted with hyperglycemia.
- During the intervention period, the study team visited the ward daily and guided the medical staff as to the use of the treatment protocol.
- During the post-intervention period, the study team collected the data without active intervention in the implementation of the protocol.
- Data was collected on the mode of treatment and glycemic control of all hyperglycemic patients throughout the study. The incidence of hypoglycemia, complications (myocardial infarction, stroke, infections), mortality, transfer to intensive care unit (ICU), length of hospitalization, and disposition at discharge were noted.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the internal medicine ward with hyperglycemia
Key exclusion criteria (1 listed)
- Patients admitted due to hypoglycemia, hyperosmolar state, and ketoacidosis
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 |
|---|---|---|
| Implementation of a protocol for treatment of hyperglycemia | Behavioural | – |
Primary outcome
Mean blood glucose during hospitalization
5 secondary outcomes
Hypoglycemic events
Length of in-hospital stay
Infections
Complications (myocardial infarction, stroke)
Disposition at discharge (home, nursing home)
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 26 Mar 2007.
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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.
Gil Leibowitz, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of a protocol for treatment of hyperglycemia in people with Diabetes and Hyperglycemia, run by Hadassah Medical Organization at 1 site in Israel.
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 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 26 Mar 2007. 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 Israel. 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?
Mean blood glucose 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 26 Mar 2007.