Text Size

Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical

This study has been completed.
Sponsor:
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01154413
First received: June 29, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

To asses the effectiveness of implementing a diabetes management protocol (early insulinization, avoiding use of SSI) in a hearth hospital's non-intensive care unit.


Condition Intervention
Diabetes Mellitus Type 2
 Behavioral: Intensive education of the doctor/nursing team on the protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:

Primary Outcome Measures:
  • Reduction in hypo/hyperglycemia episodes

Secondary Outcome Measures:
  • Lower mean glycemia, reduced time of stay in hospital

Enrollment: 182
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive education of the doctor/nursing team on the protocol Behavioral: Intensive education of the doctor/nursing team on the protocol
No Intervention: Without intervention in the team Behavioral: Intensive education of the doctor/nursing team on the protocol

Detailed Description:

Management of diabetes in patients admitted to non-intensive unit of a cardiology hospital in order to reduce the number of episodes of hypo-and hyperglycemia, improve glucose control and reducing the number of hospital days.

Eligibility criteria:

Patients with previous history of diabetes mellitus type 2, or are in use of oral antidiabetics or insulin or having fasting glucose or less 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, aged greater 18 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Previous history of diabetes mellitus type 2, or they were using oral anti-diabetic or insulin had a fasting glucose greater than or equal to 126 mg / dL or random blood glucose greater 200 mg / dL in both sexes, age greater than or equal 18 years

Exclusion Criteria:

  • Patients with known presence of cancer, while using corticosteroids, immunosuppressants on hemodialysis, with cognitive and neurological sequelae, patients whose admission had shorter duration than 72 hours, when they came transferred from intensive care units in other protocols using insulin when no doctor would agree to join the protocol and those who do not agree to participate in the study
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Maria Antonieta Pereira de Moraes, Instituto de Cardiologia Fundação Universitária de Cardiologia
ClinicalTrials.gov Identifier: NCT01154413     History of Changes
Other Study ID Numbers: UP3984/07
Study First Received: June 29, 2010
Last Updated: June 29, 2010
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013