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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT04016584
Study groupRoleWhat they receive
Latino adults with type 2 diabetesExperimentalParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted11 Jul 2019
  2. Study start10 May 2019
  3. Primary completion25 Feb 2020
  4. Study completion25 Feb 2020

Resources

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)
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

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.

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