NCT05969015Completed
Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study
Educação em saúde Intensiva na atenção primária à saúde em Pacientes Com Diabetes Mellitus Tipo 2: um Ensaio clínico Randomizado - The Diabetes Care (D-CARE) Study
Source: ClinicalTrials.gov · Last updated 29 May 2024
Brief summary (registry, in English)
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 treatment is highly dependent on self-management, which very often incurs the necessity of behavior change. However, modifying such behaviors, usually linked to daily-life activities, is challenging. Then, the investigators aimed to test the optimal self-management that could be achieved in a reasonable manner carried forward through the Prochaska and DiClemente behavior-changing strategy in a follow-up of 18 months, compared to usual care. Our primary outcome is the between-group difference in HbA1c (%) levels.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 174 (actual)
- First submitted
- 10 Jul 2023
- Start date
- Jan 2022
- Primary completion date
- Dec 2023
- Lead sponsor
- Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
- Diseases
- Type 2 diabetes
- NCT number
- NCT05969015
What you commit to
- Study type: Interventional
- Participants enrolled: 174
- From Jan 2022 to the primary completion date, Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- People living with HIV/AIDS;
- T2DM patients with severe eye and retine disease;
Other
- Pregnant women;
- T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia;
- Patients participating in another study simultaneously;
- Patients living with others in the same place.
Who the study is looking for
- 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.);
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidade do Extremo Sul Catarinense Coordinator of this site? Confirm its status | Criciúma | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.