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

Diabetes Mellitus Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154413
• Other study ID #: UP3984/07
• Status: Completed
• Phase: N/A
• First received: June 29, 2010
• Last updated: June 29, 2010
• Start date: December 2007
• Est. completion date: May 2009

Study information

• Verified date: June 2010
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: May 2009
• Est. primary completion date: December 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Intensive education of the doctor/nursing team on the protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in hypo/hyperglycemia episodes
Secondary	Lower mean glycemia, reduced time of stay in hospital