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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Drug: Basal bolus insulin regimen (tight glucose control); Drug: Basal bolus insulin regimen (standard control)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zerifin, Israel, 70300
    • Assaf Harofeh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ANTICIPATED): June 1, 2011
• Study Completion (ANTICIPATED): July 1, 2011

Study Registration Dates

• First Submitted: December 21, 2008
• First Submitted That Met QC Criteria: December 22, 2008
• First Posted (ESTIMATE): December 23, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 23, 2008
• Last Update Submitted That Met QC Criteria: December 22, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: cardio vascular outcome
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 184-08