Implementation of a Diabetes Management Protocol as Compared to Conventional Management in a Heart Hospital's Non-Intensive Care Unit: Randomized Clinical
1 other identifier
interventional
182
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus-type-2
Started Dec 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
June 30, 2010
CompletedJune 30, 2010
June 1, 2010
Same day
June 29, 2010
June 29, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in hypo/hyperglycemia episodes
Secondary Outcomes (1)
Lower mean glycemia, reduced time of stay in hospital
Study Arms (2)
Intensive education of the doctor/nursing team on the protocol
EXPERIMENTALWithout intervention in the team
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Moraes MA, Rodrigues J, Cremonesi M, Polanczyk C, Schaan BD. Management of diabetes by a healthcare team in a cardiology unit: a randomized controlled trial. Clinics (Sao Paulo). 2013 Nov;68(11):1400-7. doi: 10.6061/clinics/2013(11)03.
PMID: 24270950DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2010
First Posted
June 30, 2010
Study Start
December 1, 2007
Primary Completion
December 1, 2007
Study Completion
May 1, 2009
Last Updated
June 30, 2010
Record last verified: 2010-06