DiabetesNCT00813475
Effect of Diabetes Control on Outcome in Hospitalized Patients: A National Israeli Study
A study of Diabetes, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
To test whether tight glucose control is associated with better clinical outcome compared to less-tight control, among diabetic patients hospitalized in internal medicine wards. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jul 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: >18 years
- Fasting plasma glucose > 140 mg/dl or non-fasting plasma glucose >200 mg/dl in two separate blood tests if non-diabetic, or in a single blood test if have pre-diagnosed diabetes
- Able to understand the study objective and methods and willing to provide a written informed consent
- No significant liver disease
- Serum creatinine <2.0 mg/dl
- -
Who cannot join
- Significant cognitive impairment
- History of hypoglycemia unawareness or clinical autonomic diabetic neuropathy
- Known allergy to insulin analogues
- Diabetic ketoacidosis or non-ketotic hyperosmolar coma on admission
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Tight Glucose Control of Diabetic Patients Hospitalized In General Internal Medicine Wards A National Israeli Study
To test whether tight glucose control is associated with better clinical outcome compared to less-tight control, among diabetic patients hospitalized in internal medicine wards.
Read the detailed description
Patient characteristics:
Patients admitted to internal medicine departments in public hospitals of Israel who have pre-admission diagnosis of diabetes, or have a random plasma glucose >200 mg/dl on admission
Eligibility criteria
- Age: >18 years
- Fasting plasma glucose > 140 mg/dl or non-fasting plasma glucose >200 mg/dl in two separate blood tests if non-diabetic, or in a single blood test if have pre-diagnosed diabetes
- Able to understand the study objective and methods and willing to provide a written informed consent
- No significant liver disease
- Serum creatinine <2.0 mg/dl
Exclusion criteria
- Significant cognitive impairment
- History of hypoglycemia unawareness or clinical autonomic diabetic neuropathy
- Known allergy to insulin analogues
- Diabetic ketoacidosis or non-ketotic hyperosmolar coma on admission
Process of patient recruitment and randomization:
- Enrolment of eligible patients signing the informed consent.
- Assignment of patients to different treatment arms according to randomization scheme provided by the central organizing committee.
- The ratio of patients' assignment to the active or to the control study arm will be 1:1 for each participating ward.
Protocol:
Basal bolus insulin treatment will be applied to achieve tight glucose target (mean fasting blood glucose<130 mg/dl and not above 180 mg/dl during the day) compared to patients treated to achieve less tight glucose targets (mean fasting blood glucose<200 mg/dl and not above 220 mg/dl during the day)will influence cardiovascular and general clinical outcome.
Primary outcome: All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital
Secondary outcomes:
Total number of in-hospital days during one year follow-up (including the index hospital admission)
The rate of any major clinical events (all-cause mortality, hospital acquired infection, organ failure, need of ventilation support, need of vasoactive amine administration, need of central line insertion, hospital admission for stroke, acute coronary event, severe bacterial or fungal infection) during one year follow-up
Hypoglycemic events during index hospital stay.
- Conditions
- Diabetes
- Being tested
- Basal bolus insulin regimen (tight glucose control), Basal bolus insulin regimen (standard control)
- Keywords
- cardio vascular outcome
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basal bolus insulin regimen (tight glucose control)Drug
Basal bolus insulin regimen
Basal bolus insulin regimen (standard control)Drug
basal bolus insulin regimen
| Study group | Role | What they receive |
|---|---|---|
| tight control | Experimental | Not described Receives: Drug: Basal bolus insulin regimen (tight glucose control) |
| standard control | Experimental | basal bolus insulin regimen Receives: Drug: Basal bolus insulin regimen (standard control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital
Measured: 1.5 years
Secondary outcomes (1)
Total # of in-hospital days during 1 year follow-up.The rate of any major clinical events during 1 year follow-up. Hypoglycemic events during index hospital stay
Measured: 1.5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
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.
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813475
- Sponsor's protocol ID
- 184-08
- Status last verified
- Dec 2008
- First submitted
- 21 Dec 2008
- Last updated
- 23 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Tight Glucose Control of Diabetic Patients Hospitalized In General Internal Medicine Wards A National Israeli Study
- ClinicalTrials.gov ID
- NCT00813475
- Acronym / sponsor ID
- 184-08
- Conditions
- Diabetes
- Keywords
- cardio vascular outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 23 Dec 2008 (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 test whether tight glucose control is associated with better clinical outcome compared to less-tight control, among diabetic patients hospitalized in internal medicine wards.
Detailed description
Patient characteristics:
Patients admitted to internal medicine departments in public hospitals of Israel who have pre-admission diagnosis of diabetes, or have a random plasma glucose >200 mg/dl on admission
Eligibility criteria
- Age: >18 years
- Fasting plasma glucose > 140 mg/dl or non-fasting plasma glucose >200 mg/dl in two separate blood tests if non-diabetic, or in a single blood test if have pre-diagnosed diabetes
- Able to understand the study objective and methods and willing to provide a written informed consent
- No significant liver disease
- Serum creatinine <2.0 mg/dl
Exclusion criteria
- Significant cognitive impairment
- History of hypoglycemia unawareness or clinical autonomic diabetic neuropathy
- Known allergy to insulin analogues
- Diabetic ketoacidosis or non-ketotic hyperosmolar coma on admission
Process of patient recruitment and randomization:
- Enrolment of eligible patients signing the informed consent.
- Assignment of patients to different treatment arms according to randomization scheme provided by the central organizing committee.
- The ratio of patients' assignment to the active or to the control study arm will be 1:1 for each participating ward.
Protocol:
Basal bolus insulin treatment will be applied to achieve tight glucose target (mean fasting blood glucose<130 mg/dl and not above 180 mg/dl during the day) compared to patients treated to achieve less tight glucose targets (mean fasting blood glucose<200 mg/dl and not above 220 mg/dl during the day)will influence cardiovascular and general clinical outcome.
Primary outcome: All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital
Secondary outcomes:
Total number of in-hospital days during one year follow-up (including the index hospital admission)
The rate of any major clinical events (all-cause mortality, hospital acquired infection, organ failure, need of ventilation support, need of vasoactive amine administration, need of central line insertion, hospital admission for stroke, acute coronary event, severe bacterial or fungal infection) during one year follow-up
Hypoglycemic events during index hospital stay.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tight control | Experimental | Drug: Basal bolus insulin regimen (tight glucose control) |
| standard control | Experimental | Drug: Basal bolus insulin regimen (standard control)basal bolus insulin regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: >18 years
- Fasting plasma glucose > 140 mg/dl or non-fasting plasma glucose >200 mg/dl in two separate blood tests if non-diabetic, or in a single blood test if have pre-diagnosed diabetes
- Able to understand the study objective and methods and willing to provide a written informed consent
- No significant liver disease
- Serum creatinine <2.0 mg/dl
Key exclusion criteria (5 listed)
- Significant cognitive impairment
- History of hypoglycemia unawareness or clinical autonomic diabetic neuropathy
- Known allergy to insulin analogues
- Diabetic ketoacidosis or non-ketotic hyperosmolar coma on admission
- -
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 |
|---|---|---|
| Basal bolus insulin regimen (tight glucose control)Basal bolus insulin regimen | Drug | tight control |
| Basal bolus insulin regimen (standard control)basal bolus insulin regimen | Drug | standard control |
Primary outcome
All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital
Time frame: 1.5 years
1 secondary outcome
Total # of in-hospital days during 1 year follow-up.The rate of any major clinical events during 1 year follow-up. Hypoglycemic events during index hospital stay
Time frame: 1.5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetes, run by Assaf-Harofeh Medical Center 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Dec 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas E Buchs, MD (972-57-7345025, abuchs@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital (time frame: 1.5 years). 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 23 Dec 2008.