NCT00813475

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

2.4 years

First QC Date

December 21, 2008

Last Update Submit

December 22, 2008

Conditions

Diabetes

Keywords

cardio vascular outcome

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality (including in-hospital and up to 12 months post discharge) or re-admission to hospital

    1.5 years

Secondary Outcomes (1)

  • 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

Study Arms (2)

tight control

EXPERIMENTAL
Drug: Basal bolus insulin regimen (tight glucose control)

standard control

EXPERIMENTAL

basal bolus insulin regimen

Drug: Basal bolus insulin regimen (standard control)

Interventions

Basal bolus insulin regimen (tight glucose control)DRUG

Basal bolus insulin regimen

tight control
Basal bolus insulin regimen (standard control)DRUG

basal bolus insulin regimen

standard control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Andreas E Buchs, MD

CONTACT

972-57-7345025abuchs@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 21, 2008

First Posted

December 23, 2008

Study Start

January 1, 2009

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

December 23, 2008

Record last verified: 2008-12

Locations

IL(1)