Effect of Diabetes Control on Outcome in Hospitalized Patients: A National Israeli Study
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|ClinicalTrials.gov Identifier: NCT00813475|
Recruitment Status : Unknown
Verified December 2008 by Assaf-Harofeh Medical Center.
Recruitment status was: Not yet recruiting
First Posted : December 23, 2008
Last Update Posted : December 23, 2008
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Drug: Basal bolus insulin regimen (tight glucose control) Drug: Basal bolus insulin regimen (standard control)||Not Applicable|
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
- 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
- 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.
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
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||June 2011|
|Estimated Study Completion Date :||July 2011|
|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
- All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital [ Time Frame: 1.5 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813475
|Contact: Andreas E Buchs, MDemail@example.com|
|Assaf Harofeh Medical Center||Not yet recruiting|
|Zerifin, Israel, 70300|
|Principal Investigator: Andreas E Buchs, MD|