Clinical trial NCT04016584: Diabetes Pueblo Program - Application and Acceptability of Culturally Appropriate Latino Education for Insulin Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: Type 2 Diabetes
Latino/Hispanic
Promotore
Community health worker
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2019-07-11
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
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.
timeFrame: 11 weeks
Secondary outcomes:
measure: Diabetes self management evaluated by questionnaire
timeFrame: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class
measure: Insulin treatment evaluated by questionnaire
timeFrame: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
measure: Participant evaluation of Diabetes Pueblo evaluated by questionnaire
timeFrame: Class 4, week 4; Class 8, week 8; Class 10, week 10
measure: Participant evaluation of Diabetes Pueblo evaluated by questionnaire
timeFrame: Class 11, week 11
Other outcomes:
measure: Fingerstick for evaluation of HbA1c related to diabetes
timeFrame: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
measure: Height measured by Physical exam
timeFrame: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
measure: Weight measured by Physical exam
timeFrame: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
measure: Waist circumference measured by Physical exam
timeFrame: Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class
measure: Socio-demographics assessed by questionnaire
timeFrame: Visit 1, week 0 Screening
measure: Foot examination evaluated by Questions
timeFrame: Visit 1, week 0 Screening
measure: Neuropathy Questions
timeFrame: Visit 1, week 0 Screening
measure: Retinopathy Questions
timeFrame: Visit 1, week 0 Screening
measure: Nephropathy Questions
timeFrame: Visit 1, week 0 Screening
measure: Medical history and medication status and history assessed by questionnaire
timeFrame: Visit 1, week 0 Screening
measure: Menopausal status, pregnancy status, and gestational diabetes history for women determined by questionnaire
timeFrame: Visit 1, week 0 Screening
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Sansum Diabetes Research Institute
name: Jamie Creason, RD
role: PRINCIPAL_INVESTIGATOR
References: