Clinical trial NCT00813475: Effect of Diabetes Control on Outcome in Hospitalized Patients: A National Israeli Study
Official title: Clinical Outcome of Tight Glucose Control of Diabetic Patients Hospitalized In General Internal Medicine Wards A National Israeli Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: cardio vascular outcome
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-12-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

   -

Primary outcomes:
measure: All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital
timeFrame: 1.5 years
Secondary outcomes:
measure: 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
timeFrame: 1.5
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
References: