Type 2 Diabetes, Hispanic/Latinos, Diabetes Self-management EducationEarly Phase 1Yo PuedoNCT01251497
¡Si, Yo Puedo Control Mi Diabetes!: A Diabetes Self-management Education Program for Hispanic/Latinos
A Early Phase 1 study testing diabetes self-management education in people with Type 2 Diabetes, Hispanic/Latinos, Diabetes Self-management Education, run by Texas AgriLife Extension Service.
Trial summary
The purpose of the study is to evaluate the effectiveness of the íSi, Yo Puedo Controlar Mi Diabetes! (Yo Puedo) diabetes self-management education program. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 2 Diabetes, Hispanic/Latinos, Diabetes Self-management Education
- What is being tested?
- diabetes self-management education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2009to Oct 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Self-identification as Hispanic/Latino, over the age of 18 years of age, diagnosis of type 2 diabetes and willingness to participate in the diabetes self-management education class.
Exclusion Criteria: non-diabetic persons, non English-speaking Hispanic/Latinos with type 2 diabetes
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About this study
The purpose of the study is to evaluate the effectiveness of the íSi, Yo Puedo Controlar Mi Diabetes! (Yo Puedo) diabetes self-management education program.
- Being tested
- diabetes self-management education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetes self-management educationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes, Hispanic/Latinos, Diabetes Self-management EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Texas AgriLife Extension Service
- Sponsor type
- University, hospital or other
- Collaborators
- Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251497
- Sponsor's protocol ID
- texn0043
- Acronym
- Yo Puedo
- Status last verified
- Nov 2010
- First submitted
- 1 Dec 2010
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ¡Si, Yo Puedo Control Mi Diabetes!: A Diabetes Self-management Education Program for Hispanic/Latinos
- ClinicalTrials.gov ID
- NCT01251497
- Acronym / sponsor ID
- Yo Puedo / texn0043
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Texas AgriLife Extension ServiceUniversity, hospital or other
- Collaborators
- Texas A&M University
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effectiveness of the íSi, Yo Puedo Controlar Mi Diabetes! (Yo Puedo) diabetes self-management education program.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diabetes self-management education | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing diabetes self-management education in people with Type 2 Diabetes, Hispanic/Latinos, Diabetes Self-management Education, run by Texas AgriLife Extension Service.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2010.