Effect of Diabetes Control on Outcome in Hospitalized Patients: A National Israeli Study

December 22, 2008 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

  1. Age: >18 years
  2. 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
  3. Able to understand the study objective and methods and willing to provide a written informed consent
  4. No significant liver disease
  5. Serum creatinine <2.0 mg/dl

Exclusion criteria

  1. Significant cognitive impairment
  2. History of hypoglycemia unawareness or clinical autonomic diabetic neuropathy
  3. Known allergy to insulin analogues
  4. Diabetic ketoacidosis or non-ketotic hyperosmolar coma on admission

Process of patient recruitment and randomization:

  1. Enrolment of eligible patients signing the informed consent.
  2. Assignment of patients to different treatment arms according to randomization scheme provided by the central organizing committee.
  3. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: >18 years
  2. 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
  3. Able to understand the study objective and methods and willing to provide a written informed consent
  4. No significant liver disease

  5. Serum creatinine <2.0 mg/dl

    -

Exclusion Criteria:

  1. Significant cognitive impairment
  2. History of hypoglycemia unawareness or clinical autonomic diabetic neuropathy
  3. Known allergy to insulin analogues

  4. Diabetic ketoacidosis or non-ketotic hyperosmolar coma on admission

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: tight control
Drug: Basal bolus insulin regimen (tight glucose control)
Basal bolus insulin regimen
EXPERIMENTAL: standard control
basal bolus insulin regimen
Drug: Basal bolus insulin regimen (standard control)
basal bolus insulin regimen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital
Time Frame: 1.5 years
1.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
1.5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 184-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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