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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00813475
First received: December 21, 2008
Last updated: December 22, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention
Diabetes
Drug: Basal bolus insulin regimen (tight glucose control)
Drug: Basal bolus insulin regimen (standard control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Clinical Outcome of Tight Glucose Control of Diabetic Patients Hospitalized In General Internal Medicine Wards A National Israeli Study

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813475

Contacts
Contact: Andreas E Buchs, MD 972-57-7345025 abuchs@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Principal Investigator: Andreas E Buchs, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Dr. Andreas E. Buchs, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00813475     History of Changes
Other Study ID Numbers: 184-08
Study First Received: December 21, 2008
Last Updated: December 22, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
cardio vascular outcome

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014