Type2 DiabetesDiabPuebloNCT04016584
Diabetes Pueblo Program - Application and Acceptability of Culturally Appropriate Latino Education for Insulin Therapy
A study testing Diabetes Pueblo in people with Type2 Diabetes, run by Sansum Diabetes Research Institute at 1 site in United States.
Trial summary
Currently in the United States, the achieved level of glycemic control for adult Latinos with type 2 diabetes (T2D) is sub-optimal compared to the non-Latino Caucasian population. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Diabetes Pueblo
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2019to 25 Feb 2020
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals > 18 years of age
- Self-reported Latino heritage
- Fluent in Spanish
- Type 2 diabetes diagnosis
- Available to attend the educational series and all study visits
- Willingness to have height, weight, waist circumference, and HbA1c measured before and after the educational course
Show all 17Show fewer
- Individuals with poor glycemic control, as defined by the following:
- HbA1c ≥ 8% at or prior to enrollment assessment (most recent lab within 3 months or provided at Sansum Diabetes Research Institute (SDRI) screening visit),
- OR
- HbA1c < 8% (within the last 3 months), AND with at least one of the following (also within the last 3 months):
- Fasting plasma glucose ≥ 130 mg/dL
- 2-hour post-prandial or random blood glucose ≥ 180 mg/dL
- ≥1 hypoglycemic event (blood glucose < 70 mg/dL)
- OR
- Individuals new to insulin or being considered for insulin therapy by their healthcare provider
- Willing and able to provide consent to take part in the study
- Based on the research staff's judgment, participant must have a good understanding, ability, and willingness to adhere to the protocol
Who cannot join
- Has a cognitive impairment, hearing difficulty, visual impairment, acute psychopathology, medical condition, or insufficient knowledge of the education program language that, in the opinion of the screener, would interfere with the ability to provide consent and participate/complete the program
- Participation in other studies involving medications or device within 3 months prior to Visit 1
- Known or suspected abuse of alcohol, narcotics, or illicit drugs
- Current use of insulin pump
- For females: Pregnancy or positive pregnancy test
- Pharmaceutical employees or those employed in a position where they have a direct role in treating participants with diabetes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93463
About this study
Official title: Diabetes Pueblo Program - The Application and Acceptability of Culturally Appropriate Education Programs for Current or Potential Insulin Therapy Users With Type 2 Diabetes in the Latino Community
Currently in the United States, the achieved level of glycemic control for adult Latinos with type 2 diabetes (T2D) is sub-optimal compared to the non-Latino Caucasian population. Among Latinos with T2D, there are unique barriers, such as socioeconomic and cultural factors, to starting and optimizing therapies, including insulin. Latinos have cultural beliefs and behaviors specific to this population that should be appropriately addressed in a diabetes self-management education and support program. Diabetes Pueblo is a diabetes education program that may be a solution to help address the barriers Latinos with T2D have to diabetes care and insulin use. The Diabetes Pueblo program consists of two targeted diabetes education curriculums for the local Latino community: (a) Diabetes Fundamentals and (b) Insulin Success, a culturally appropriate program course addressing barriers to initiating and optimizing insulin and T2D therapies. We will explore if Diabetes Pueblo Program improves knowledge of lifestyle advice for healthy eating and physical activity, increase the propensity to use insulin when clinically indicated, and improve success rates with insulin therapy by addressing common fears and negative perceptions of T2D therapies in this population.
Read the detailed description
Diabetes mellitus (DM) is a group of chronic disorders typified by raised blood glucose levels. An estimated 30 million people in the United States (US) (9.4% of the population) have diabetes. Type 1 diabetes (T1D) is defined by a rapid onset, often in childhood, and insulin dependence; while type 2 diabetes (T2D) is considered to have a slow onset and insulin insensitivity. Insulin is a required form of treatment for all T1D, and T2D patients who cannot achieve glycemic control through exercise and diet or other medications alone. Currently in the United States, the achieved level of glycemic control for adult Latinos with type 2 diabetes (T2D) is sub-optimal compared to the non-Latino Caucasian population. Among Latinos with T2D, there are unique barriers to starting and optimizing therapies, including insulin. Barriers include socioeconomic and cultural factors, as well as inadequate encouragement from health care providers. There are also challenges associated with access to timely and appropriate diabetes education. Some of these barriers may improve by using trained community health workers from the Latino community, as there is evidence that they are effective in supporting adherence and persistence with therapies (including insulin) and in encouraging lifestyle changes for T2D patients within their own communities.
The 2017 National Standards of Care for Diabetes Self-Management Education and Support (DSME/S) outline quality, evidenced based guidelines for DSME/S programs and guide those who will be providing these services. Benefits of DSME/S programs include improved clinical outcomes such as HbA1c and quality of life while reducing hospitalizations and health care costs. Hispanics are known to have a higher prevalence of diabetes, but use of DSME/S programs are vastly underutilized which means that many individuals in the Latino community with T2D are likely not receiving critical DSME/S services. It is crucial that DSME/S services be aligned with the needs of the target population in order to increase adherence and improve health outcomes. Latinos have cultural beliefs and behaviors specific to this population that should be appropriately addressed in a DSME/S program.
Diabetes Pueblo is a diabetes education program that may be a solution to help address the barriers Latinos with T2D have to diabetes care and insulin use. The Diabetes Pueblo program consists of two targeted diabetes education curriculums for the local Latino community: (a) Diabetes Fundamentals and (b) Insulin Success, a culturally appropriate program course addressing barriers to initiating and optimizing insulin and T2D therapies. Trained community health workers, also known as promotores, will deliver both programs. Ultimately, we will explore if Diabetes Pueblo Program improves knowledge of lifestyle advice for healthy eating and physical activity, increase the propensity to use insulin when clinically indicated, and improve success rates with insulin therapy by addressing common fears and negative perceptions of T2D therapies in this population.
This is a prospective pilot study. The Diabetes Pueblo program applied in this study is one program that consists of two newly created, targeted education curriculums for T2D Latino adults delivered over the course of 11 weeks by designated promotores, community health workers, to approximately 20 study participants at Sansum Diabetes Research Institute.
- Conditions
- Type2 Diabetes
- Being tested
- Diabetes Pueblo
- Keywords
- Type 2 Diabetes, Latino/Hispanic, Promotore, Community health worker
- 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 PuebloBehavioural
These adults will receive diabetes education, the Diabetes Pueblo Program, and will complete Curriculum (A), Diabetes Fundamentals, and Curriculum (B), Insulin Success.
| Study group | Role | What they receive |
|---|---|---|
| Latino adults with type 2 diabetes | Experimental | Participants of the Diabetes Pueblo Education Program will include adults with T2D from the Santa Barbara Latino community whose diabetes is poorly controlled, defined as -
1. hemoglobin A1c > 8% at or prior to enrollment, or
2. hemoglobin A1c < 8% (within the last 3 months), AND with at least one of the following (also within the last 3 months):
* Fasting plasma glucose > 130 mg/dL
* 2-hour post-prandial or random blood glucose > 180 mg/dL
* > 1 hypoglycemic event (blood glucose < 70 mg/dL) , or
3. adults with T2D from the community who are new to insulin or being considered for insulin therapy by their healthcare provider. Receives: Behavioral: Diabetes Pueblo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success (evaluated by a Yes/No format) recruiting and completing a new targeted diabetes and insulin education program, Diabetes Pueblo, for Latino adults with type 2 diabetes.
The Diabetes Pueblo program consists of two newly created, targeted education curriculums, Diabetes Fundamentals and Insulin Success, for Latino adults with type 2 diabetes. It will be delivered over the course of 11 weeks by designated promotores, community health workers, to approximately 20 study participants at Sansum Diabetes Research Institute.
Measured: 11 weeks
Secondary outcomes (4)
Diabetes self management evaluated by questionnaire
The Diabetes Self-Management Questionnaire consists of 16 questions to evaluate diabetes self-care including glucose management, dietary control, physical activity, and health-care use. Questions are rated on a 4 point scale - 0 Does not apply to me, 1 Applies to me to some degree, 2 Applies to me to a considerable degree, 3 Applies to me very much. This yields an overall rating of self-care with higher scores indicating more effective diabetes self-care.
Measured: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class
Insulin treatment evaluated by questionnaire
The Insulin Treatment Appraisal Scale is a validated 20-item questionnaire that will be used in insulin naïve and insulin-treated patients with type 2 diabetes to assess positive and negative perceptions regarding insulin treatment. Items are rated on a 5-point scale ("strongly disagree" to "strongly agree") and the mean of individual item scores is calculated to obtain a total score, with lower scores indicating less negative perceptions regarding insulin treatment.
Measured: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Participant evaluation of Diabetes Pueblo evaluated by questionnaire
The first questionnaire includes curriculum content questions which are specific to courses 1-4, 5-8, and 9-10.
Measured: Class 4, week 4; Class 8, week 8; Class 10, week 10
Participant evaluation of Diabetes Pueblo evaluated by questionnaire
The second questionnaire assesses overall program feedback on the entire program.
Measured: Class 11, week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start10 May 2019
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sansum Diabetes Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Jamie Creason, RD, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016584
- Sponsor's protocol ID
- LY2017-6000
- Acronym
- DiabPueblo
- Status last verified
- Sep 2021
- First submitted
- 9 Jul 2019
- Last updated
- 5 Sep 2021
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Pueblo Program - The Application and Acceptability of Culturally Appropriate Education Programs for Current or Potential Insulin Therapy Users With Type 2 Diabetes in the Latino Community
- ClinicalTrials.gov ID
- NCT04016584
- Acronym / sponsor ID
- DiabPueblo / LY2017-6000
- Conditions
- Type2 Diabetes
- Keywords
- Type 2 Diabetes, Latino/Hispanic, Promotore, Community health worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sansum Diabetes Research InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 10 May 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 11 Jul 2019 (actual)
- 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.
Currently in the United States, the achieved level of glycemic control for adult Latinos with type 2 diabetes (T2D) is sub-optimal compared to the non-Latino Caucasian population. Among Latinos with T2D, there are unique barriers, such as socioeconomic and cultural factors, to starting and optimizing therapies, including insulin. Latinos have cultural beliefs and behaviors specific to this population that should be appropriately addressed in a diabetes self-management education and support program. Diabetes Pueblo is a diabetes education program that may be a solution to help address the barriers Latinos with T2D have to diabetes care and insulin use. The Diabetes Pueblo program consists of two targeted diabetes education curriculums for the local Latino community: (a) Diabetes Fundamentals and (b) Insulin Success, a culturally appropriate program course addressing barriers to initiating and optimizing insulin and T2D therapies. We will explore if Diabetes Pueblo Program improves knowledge of lifestyle advice for healthy eating and physical activity, increase the propensity to use insulin when clinically indicated, and improve success rates with insulin therapy by addressing common fears and negative perceptions of T2D therapies in this population.
Detailed description
Diabetes mellitus (DM) is a group of chronic disorders typified by raised blood glucose levels. An estimated 30 million people in the United States (US) (9.4% of the population) have diabetes. Type 1 diabetes (T1D) is defined by a rapid onset, often in childhood, and insulin dependence; while type 2 diabetes (T2D) is considered to have a slow onset and insulin insensitivity. Insulin is a required form of treatment for all T1D, and T2D patients who cannot achieve glycemic control through exercise and diet or other medications alone. Currently in the United States, the achieved level of glycemic control for adult Latinos with type 2 diabetes (T2D) is sub-optimal compared to the non-Latino Caucasian population. Among Latinos with T2D, there are unique barriers to starting and optimizing therapies, including insulin. Barriers include socioeconomic and cultural factors, as well as inadequate encouragement from health care providers. There are also challenges associated with access to timely and appropriate diabetes education. Some of these barriers may improve by using trained community health workers from the Latino community, as there is evidence that they are effective in supporting adherence and persistence with therapies (including insulin) and in encouraging lifestyle changes for T2D patients within their own communities.
The 2017 National Standards of Care for Diabetes Self-Management Education and Support (DSME/S) outline quality, evidenced based guidelines for DSME/S programs and guide those who will be providing these services. Benefits of DSME/S programs include improved clinical outcomes such as HbA1c and quality of life while reducing hospitalizations and health care costs. Hispanics are known to have a higher prevalence of diabetes, but use of DSME/S programs are vastly underutilized which means that many individuals in the Latino community with T2D are likely not receiving critical DSME/S services. It is crucial that DSME/S services be aligned with the needs of the target population in order to increase adherence and improve health outcomes. Latinos have cultural beliefs and behaviors specific to this population that should be appropriately addressed in a DSME/S program.
Diabetes Pueblo is a diabetes education program that may be a solution to help address the barriers Latinos with T2D have to diabetes care and insulin use. The Diabetes Pueblo program consists of two targeted diabetes education curriculums for the local Latino community: (a) Diabetes Fundamentals and (b) Insulin Success, a culturally appropriate program course addressing barriers to initiating and optimizing insulin and T2D therapies. Trained community health workers, also known as promotores, will deliver both programs. Ultimately, we will explore if Diabetes Pueblo Program improves knowledge of lifestyle advice for healthy eating and physical activity, increase the propensity to use insulin when clinically indicated, and improve success rates with insulin therapy by addressing common fears and negative perceptions of T2D therapies in this population.
This is a prospective pilot study. The Diabetes Pueblo program applied in this study is one program that consists of two newly created, targeted education curriculums for T2D Latino adults delivered over the course of 11 weeks by designated promotores, community health workers, to approximately 20 study participants at Sansum Diabetes Research Institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Latino adults with type 2 diabetes | Experimental | Behavioral: Diabetes PuebloParticipants of the Diabetes Pueblo Education Program will include adults with T2D from the Santa Barbara Latino community whose diabetes is poorly controlled, defined as - 1. hemoglobin A1c > 8% at or prior to enrollment, or 2. hemoglobin A1c < 8% (within the last 3 months), AND with at least one of the following (also within the last 3 months): * Fasting plasma glucose > 130 mg/dL * 2-hour post-prandial or random blood glucose > 180 mg/dL * > 1 hypoglycemic event (blood glucose < 70 mg/dL) , or 3. adults with T2D from the community who are new to insulin or being considered for insulin therapy by their healthcare provider. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Individuals > 18 years of age
- Self-reported Latino heritage
- Fluent in Spanish
- Type 2 diabetes diagnosis
- Available to attend the educational series and all study visits
Key exclusion criteria (6 listed)
- Has a cognitive impairment, hearing difficulty, visual impairment, acute psychopathology, medical condition, or insufficient knowledge of the education program language that, in the opinion of the screener, would interfere with the ability to provide consent and participate/complete the program
- Participation in other studies involving medications or device within 3 months prior to Visit 1
- Known or suspected abuse of alcohol, narcotics, or illicit drugs
- Current use of insulin pump
- For females: Pregnancy or positive pregnancy test
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 PuebloThese adults will receive diabetes education, the Diabetes Pueblo Program, and will complete Curriculum (A), Diabetes Fundamentals, and Curriculum (B), Insulin Success. | Behavioural | Latino adults with type 2 diabetes |
Primary outcome
Success (evaluated by a Yes/No format) recruiting and completing a new targeted diabetes and insulin education program, Diabetes Pueblo, for Latino adults with type 2 diabetes.
Time frame: 11 weeks
The Diabetes Pueblo program consists of two newly created, targeted education curriculums, Diabetes Fundamentals and Insulin Success, for Latino adults with type 2 diabetes. It will be delivered over the course of 11 weeks by designated promotores, community health workers, to approximately 20 study participants at Sansum Diabetes Research Institute.
4 secondary outcomes
Diabetes self management evaluated by questionnaire
Time frame: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class
Insulin treatment evaluated by questionnaire
Time frame: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
Participant evaluation of Diabetes Pueblo evaluated by questionnaire
Time frame: Class 4, week 4; Class 8, week 8; Class 10, week 10
Participant evaluation of Diabetes Pueblo evaluated by questionnaire
Time frame: Class 11, week 11
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 5 Sep 2021.
- 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.
Jamie Creason, RD principal investigator
Sansum Diabetes Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Pueblo in people with Type2 Diabetes, run by Sansum Diabetes Research Institute 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 17 inclusion and 6 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: finished, as of the sponsor's last update on 5 Sep 2021. 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 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.
What does the primary outcome measure?
Success (evaluated by a Yes/No format) recruiting and completing a new targeted diabetes and insulin education program, Diabetes Pueblo, for Latino adults with type 2 diabetes. (time frame: 11 weeks). 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 5 Sep 2021.