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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Outcome of Tight Glucose Control of Diabetic Patients Hospitalized In General Internal Medicine Wards A National Israeli Study

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Basal bolus insulin regimen (tight glucose control)
* Drug: Basal bolus insulin regimen (standard control)


Participation Criteria
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Eligibility Criteria
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Inclusion 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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tight control<br> | Drug: Basal bolus insulin regimen (tight glucose control)<br>* Basal bolus insulin regimen<br>|
| Experimental: standard control<br>basal bolus insulin regimen | Drug: Basal bolus insulin regimen (standard control)<br>* basal bolus insulin regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital |  | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 1.5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardio vascular outcome