Status:
COMPLETED
Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study
Lead Sponsor:
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Collaborating Sponsors:
Prefeitura Municipal de Criciúma
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Type 2 diabetes mellitus (T2DM) leads to a high burden of morbidity and mortality, usually attributable to cardiovascular (CVD) causes. A major concern about the disease is that the success of the tre...
Eligibility Criteria
Inclusion
- Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or taking at least one oral hypoglycaemic agent, or medical diagnosis);
- To be regularly assisted by the Sistema Único de Saúde and to have been saw at least one year before randomization;
- Readiness for behavior-changing within the pre-action stages: pre-contemplation, contemplation and preparation;
- T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures, cardiovascular disease (CVD), etc.);
Exclusion
- Pregnant women;
- People living with HIV/AIDS;
- T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia;
- T2DM patients with CVD under non-optimized treatment; or those that made any CVD procedure; or CVD event (e.g., myocardial infarction) within three months before randomization;
- T2DM patients with severe eye and retine disease;
- Patients participating in another study simultaneously;
- Patients living with others in the same place.
Key Trial Info
Start Date :
January 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2024
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT05969015
Start Date
January 15 2022
End Date
May 7 2024
Last Update
May 29 2024
Active Locations (2)
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1
Universidade do Extremo Sul Catarinense
Criciúma, Santa Catarina, Brazil, 88806-000
2
Universidade do Extremo Sul Catarinense
Criciúma, Santa Catarina, Brazil, 88806000