DiabetesELDEPNCT00793884
Emory Latino Diabetes Education Program
An observational study of Diabetes, run by Emory University at 1 site in United States.
Trial summary
Latinos with diabetes who are attending the Emory Latino Diabetes education program will be approached about consenting to have clinical measurements collected to assess changes between baseline and monthly follow up sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 1,837 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Nov 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spanish speaking patients with Diabetes
Who may be able to join
- spanish speaking patients with diabetes
Who cannot join
- under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine
Atlanta, Georgia, 30303
About this study
Latinos with diabetes who are attending the Emory Latino Diabetes education program will be approached about consenting to have clinical measurements collected to assess changes between baseline and monthly follow up sessions. The no-cost educational sessions follow the self-care behavior curriculum of the American Association of Diabetes Educators (AADE).
Read the detailed description
Latinos represent the largest minority group in the United States with a population of 35 million or 12.5%. National surveys indicate that the prevalence of type 2 diabetes is 1.9 times higher in Latinos than non-whites, and that approximately 24% percent of Latinos over the age of 45 years have diabetes. In Georgia, Latinos make up approximately 6.5% of the population. During 1990 and 2000, the prevalence of diabetes in Fulton and Dekalb counties, two of the most populated areas in Georgia and the Atlanta metropolitan area increased by 30%. Language and cultural barriers represent the two most important obstacles in educating and improving the care of Latino patients with diabetes. Less than 5% of physicians, 2% of nurses, and 2.5% of dentists in the US speak Spanish.
The Emory Latino Diabetes education program has been in existence since December 2005. This program aims to deliver diabetes education in Spanish to the underserved Latino community in Metro Atlanta. Program participants attend an initial 3 hour diabetes education class in Spanish. The class curriculum follows the American Association of Diabetes Educators (AADE) seven self-care behaviors: healthy eating, being active, monitoring, medication use, problem-solving and healthy coping. Participants are invited to return to a follow-up session within 6 months. Follow-up sessions are held in the late afternoon. These sessions are discussion-based and include an activity such as salsa lessons and cooking demonstrations. Diabetes education classes and follow-up sessions are offered at Grady Memorial Hospital (Diabetes Clinic, International Medical Center), Grady North Dekalb Clinic (Chamblee), and North Fulton Regional Hospital.
Participants complete a questionnaire assessing behaviors and social and demographic characteristics of the Latino community being served. Hemoglobin A1C, blood pressure, weight, body mass index (BMI) and waist circumference will be measured at the beginning of each class. This study will analyze and publish data collected from individuals who are attending the educational sessions. Additionally, the researchers will collect retrospective data from past participants in the program.
- Conditions
- Diabetes
- Keywords
- Diabetes, Latino population
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Education | Latino individuals with diabetes who are attending the Emory Latino Diabetes Education Program (ELDEP) will be followed in order to collect outcomes on clinical measurements. The class curriculum follows the American Association of Diabetes Educators (AADE) seven self-care behaviors: healthy eating, being active, monitoring, medication use, problem-solving and healthy coping. Program participants attend an initial 3 hour diabetes education class conducted in Spanish and then are invited to return to monthly follow-up sessions covering topics of meal planning, exercise, medications and complications. The follow-up sessions include activities such as dance lessons, cooking demonstrations, and sharing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social and Demographic Characteristics
One aim of this study is to describe the social and demographic characteristics of the Latino population with diabetes mellitus in Georgia. Participants will complete a qualitative demographic survey including questions regarding medical care received, physical activity, medications taken and blood sugar monitoring habits.
Measured: 5 years
Secondary outcomes (7)
Barriers to Health Care
To examine barriers to health care among Latinos with Diabetes in the population served participants will be asked qualitative questions about what type of health insurance they have and if they have a physician that they see.
Measured: 5 years
Change in Blood Glucose Level
Blood glucose levels are measured in milligrams of glucose per deciliter of blood (mg/dL). Normal fasting levels are between 70 and 99 mg/dL and diabetes is indicated when fasting glucose levels are greater than 125 mg/dL.
Measured: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Hemoglobin A1C
The hemoglobin A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.
Measured: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Waist Circumference
Waist circumference is measured in centimeters (cm).
Measured: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Body Mass Index (BMI)
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.
Measured: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Systolic Blood Pressure
Blood pressure will be measured using blood pressure monitor. Normal systolic blood pressure is less than 120 millimeter of mercury (mm/Hg) and high blood pressure is typically diagnosed at measurements of 130 mm/Hg and higher.
Measured: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Diastolic Blood Pressure
Blood pressure will be measured using blood pressure monitor. Normal diastolic blood pressure is less than 80 mm/Hg and high blood pressure is typically diagnosed at measurements of 80 mm/Hg and higher.
Measured: Baseline, Montly Follow-up Visits (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2019
- Study completionNov 2019
Why it stopped: Enrollment and study activities were suspended in March 2020 due to the COVID-19 pandemic and re-opening the study was delayed pending additional funding. The study was ultimately terminated in January of 2026 due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,837 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Eli Lilly and Company, Takeda, Novo Nordisk A/S
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Ina Flores, MS, RN, LD, Study director, Emory UniversityGuillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793884
- Sponsor's protocol ID
- IRB00013340
- Other IDs
- 2024P007757
- Acronym
- ELDEP
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2008
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emory Latino Diabetes Education Program
- ClinicalTrials.gov ID
- NCT00793884
- Acronym / sponsor ID
- ELDEP / IRB00013340
- Conditions
- Diabetes
- Keywords
- Diabetes, Latino population
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment and study activities were suspended in March 2020 due to the COVID-19 pandemic and re-opening the study was delayed pending additional funding. The study was ultimately terminated in January of 2026 due to lack of funding.
- Enrolment
- 1,837 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Sanofi, Eli Lilly and Company, Takeda, Novo Nordisk A/S
- Study start
- Oct 2008 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 19 Nov 2008 (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.
Latinos with diabetes who are attending the Emory Latino Diabetes education program will be approached about consenting to have clinical measurements collected to assess changes between baseline and monthly follow up sessions. The no-cost educational sessions follow the self-care behavior curriculum of the American Association of Diabetes Educators (AADE).
Detailed description
Latinos represent the largest minority group in the United States with a population of 35 million or 12.5%. National surveys indicate that the prevalence of type 2 diabetes is 1.9 times higher in Latinos than non-whites, and that approximately 24% percent of Latinos over the age of 45 years have diabetes. In Georgia, Latinos make up approximately 6.5% of the population. During 1990 and 2000, the prevalence of diabetes in Fulton and Dekalb counties, two of the most populated areas in Georgia and the Atlanta metropolitan area increased by 30%. Language and cultural barriers represent the two most important obstacles in educating and improving the care of Latino patients with diabetes. Less than 5% of physicians, 2% of nurses, and 2.5% of dentists in the US speak Spanish.
The Emory Latino Diabetes education program has been in existence since December 2005. This program aims to deliver diabetes education in Spanish to the underserved Latino community in Metro Atlanta. Program participants attend an initial 3 hour diabetes education class in Spanish. The class curriculum follows the American Association of Diabetes Educators (AADE) seven self-care behaviors: healthy eating, being active, monitoring, medication use, problem-solving and healthy coping. Participants are invited to return to a follow-up session within 6 months. Follow-up sessions are held in the late afternoon. These sessions are discussion-based and include an activity such as salsa lessons and cooking demonstrations. Diabetes education classes and follow-up sessions are offered at Grady Memorial Hospital (Diabetes Clinic, International Medical Center), Grady North Dekalb Clinic (Chamblee), and North Fulton Regional Hospital.
Participants complete a questionnaire assessing behaviors and social and demographic characteristics of the Latino community being served. Hemoglobin A1C, blood pressure, weight, body mass index (BMI) and waist circumference will be measured at the beginning of each class. This study will analyze and publish data collected from individuals who are attending the educational sessions. Additionally, the researchers will collect retrospective data from past participants in the program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Education | – | –Latino individuals with diabetes who are attending the Emory Latino Diabetes Education Program (ELDEP) will be followed in order to collect outcomes on clinical measurements. The class curriculum follows the American Association of Diabetes Educators (AADE) seven self-care behaviors: healthy eating, being active, monitoring, medication use, problem-solving and healthy coping. Program participants attend an initial 3 hour diabetes education class conducted in Spanish and then are invited to return to monthly follow-up sessions covering topics of meal planning, exercise, medications and complications. The follow-up sessions include activities such as dance lessons, cooking demonstrations, and sharing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spanish speaking patients with Diabetes
Key inclusion criteria (1 listed)
- spanish speaking patients with diabetes
Key exclusion criteria (1 listed)
- under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Social and Demographic Characteristics
Time frame: 5 years
One aim of this study is to describe the social and demographic characteristics of the Latino population with diabetes mellitus in Georgia. Participants will complete a qualitative demographic survey including questions regarding medical care received, physical activity, medications taken and blood sugar monitoring habits.
7 secondary outcomes
Barriers to Health Care
Time frame: 5 years
Change in Blood Glucose Level
Time frame: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Hemoglobin A1C
Time frame: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Waist Circumference
Time frame: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Body Mass Index (BMI)
Time frame: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Systolic Blood Pressure
Time frame: Baseline, Montly Follow-up Visits (up to 5 years)
Change in Diastolic Blood Pressure
Time frame: Baseline, Montly Follow-up Visits (up to 5 years)
Results and safety
The study was stopped early (reason given: Enrollment and study activities were suspended in March 2020 due to the COVID-19 pandemic and re-opening the study was delayed pending additional funding. The study was ultimately terminated in January of 2026 due to lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Ina Flores, MS, RN, LD study director
Emory University
Guillermo Umpierrez, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: Enrollment and study activities were suspended in March 2020 due to the COVID-19 pandemic and re-opening the study was delayed pending additional funding. The study was ultimately terminated in January of 2026 due to lack of funding.). Results are not available in the source record.
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.
What does the primary outcome measure?
Social and Demographic Characteristics (time frame: 5 years). It is what the study was designed to measure, not a finding.
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 17 Feb 2026; AzTrials last refreshed its copy on 3 Nov 2026.