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

NCT04016584 | Completed

• 1 other identifier: LY2017-6000
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Keywords

Type 2 Diabetes; Latino/Hispanic; Promotore; Community health worker

Outcome Measures

Primary Outcomes (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.

  11 weeks

Secondary Outcomes (4)

• Diabetes self management evaluated by questionnaire

  Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class

• Insulin treatment evaluated by questionnaire

  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

  Class 4, week 4; Class 8, week 8; Class 10, week 10

• Participant evaluation of Diabetes Pueblo evaluated by questionnaire

  Class 11, week 11

Other Outcomes (11)

• Fingerstick for evaluation of HbA1c related to diabetes

  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 by Physical exam

  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 by Physical exam

  Visit 1, week 0 Screening; Visit 2, week 8 End of Diabetes Fundamentals class; Visit 3, week 11 End of Insulin Success class

Study Arms (1)

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.

Behavioral: Diabetes Pueblo

Interventions

Diabetes Pueblo BEHAVIORAL

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

Latino adults with type 2 diabetes

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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),
• 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
• hour post-prandial or random blood glucose ≥ 180 mg/dL
• ≥1 hypoglycemic event (blood glucose \< 70 mg/dL)
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sansum Diabetes Research Institute: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93463, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jamie Creason, RD

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 11, 2019
• Study Start: May 10, 2019
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)