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

Shamir Medical Center (Assaf-Harofeh)

Status: Unknown

Conditions: Diabetes

Treatments: Drug: Basal bolus insulin regimen (tight glucose control); Drug: Basal bolus insulin regimen (standard control)

Study type: Interventional

Funder types: Other

Identifiers

NCT00813475

184-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

tight control

Experimental group

Treatment:

Drug: Basal bolus insulin regimen (tight glucose control)

standard control

Experimental group

Description:

basal bolus insulin regimen

Treatment:

Drug: Basal bolus insulin regimen (standard control)