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Diabetes Pueblo Program - Application and Acceptability of Culturally Appropriate Latino Education for Insulin Therapy (DiabPueblo)

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ClinicalTrials.gov Identifier: NCT04016584
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: Diabetes Pueblo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Latino adults with type 2 diabetes

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.
Behavioral: Diabetes Pueblo
These adults will receive diabetes education, the Diabetes Pueblo Program, and will complete Curriculum (A), Diabetes Fundamentals, and Curriculum (B), Insulin Success.




Primary Outcome Measures :
  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. [ 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.


Secondary Outcome Measures :
  1. Diabetes self management evaluated by questionnaire [ Time Frame: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class ]
    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.

  2. 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 ]
    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.

  3. Participant evaluation of Diabetes Pueblo evaluated by questionnaire [ Time Frame: Class 4, week 4; Class 8, week 8; Class 10, week 10 ]
    The first questionnaire includes curriculum content questions which are specific to courses 1-4, 5-8, and 9-10.

  4. Participant evaluation of Diabetes Pueblo evaluated by questionnaire [ Time Frame: Class 11, week 11 ]
    The second questionnaire assesses overall program feedback on the entire program.


Other Outcome Measures:
  1. Fingerstick for evaluation of HbA1c related to diabetes [ 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 ]
    HbA1c % will measured in a capillary fingerstick blood sample

  2. Height measured by Physical exam [ 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 ]
    Height measured in centimeters or inches by physical exam

  3. Weight measured by Physical exam [ 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 ]
    Weight measured in kilograms or pounds by physical exam

  4. Waist circumference measured by Physical exam [ 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 ]
    Waist circumference measured in centimeters or inches by physical exam

  5. Socio-demographics assessed by questionnaire [ Time Frame: Visit 1, week 0 Screening ]
    Socio-demographics measured by questionnaire - including age, gender, self-identified race/ethnicity, contact information, education, occupation, preferred language, insurance status, influenza & pneumonia immunization status, alcohol & tobacco use, birth place, physical activity, food security, and mobile phone use.

  6. Foot examination evaluated by Questions [ Time Frame: Visit 1, week 0 Screening ]
    Foot examination with 'yes or no' and frequency questions

  7. Neuropathy Questions [ Time Frame: Visit 1, week 0 Screening ]
    Questions about neuropathy

  8. Retinopathy Questions [ Time Frame: Visit 1, week 0 Screening ]
    Questions about retinopathy and eye exams

  9. Nephropathy Questions [ Time Frame: Visit 1, week 0 Screening ]
    Questions about nephropathy

  10. Medical history and medication status and history assessed by questionnaire [ Time Frame: Visit 1, week 0 Screening ]
    Medical history, including date of diabetes diagnosis, type of diabetes, diabetes education, diabetes self-care, depression and stress, falls, physician visits, hospital and emergency room visits, and current medications verified by visual inspection and medication history assessed by interview questionnaire

  11. Menopausal status, pregnancy status, and gestational diabetes history for women determined by questionnaire [ Time Frame: Visit 1, week 0 Screening ]
    Menopausal status, pregnancy status (number of live births, number of stillbirths, birthweights of live births, and any diagnosis of type 1 diabetes), and gestational diabetes history for female participants will be determined by questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Individuals > 18 years of age
  2. Self-reported Latino heritage
  3. Fluent in Spanish
  4. Type 2 diabetes diagnosis
  5. Available to attend the educational series and all study visits
  6. Willingness to have height, weight, waist circumference, and HbA1c measured before and after the educational course
  7. 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
  8. Willing and able to provide consent to take part in the study
  9. Based on the research staff's judgment, participant must have a good understanding, ability, and willingness to adhere to the protocol

Exclusion Criteria:

  1. 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
  2. Participation in other studies involving medications or device within 3 months prior to Visit 1
  3. Known or suspected abuse of alcohol, narcotics, or illicit drugs
  4. Current use of insulin pump
  5. For females: Pregnancy or positive pregnancy test
  6. Pharmaceutical employees or those employed in a position where they have a direct role in treating participants with diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016584


Contacts
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Contact: Jamie Creason, RD 805-682-7640 ext 231 jcreason@sansum.org
Contact: Margarita Diaz 805-682-7640 ext 255 mdiaz@sansum.org

Locations
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United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93463
Contact: Jamie Creason, RD    805-682-7640 ext 231    jcreason@sansum.org   
Contact: Margarita Diaz    805-682-7640 ext 255    mdiaz@sansum.org   
Sponsors and Collaborators
Sansum Diabetes Research Institute
Eli Lilly and Company
Investigators
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Principal Investigator: Jamie Creason, RD Sansum Diabetes Research Institute

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Responsible Party: Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT04016584     History of Changes
Other Study ID Numbers: LY2017-6000
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sansum Diabetes Research Institute:
Type 2 Diabetes
Latino/Hispanic
Promotore
Community health worker

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs