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

Completed · Not applicable

Conditions studied: Type2 Diabetes

In brief

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.

Key facts

Study ID

NCT04016584

Run by

Sansum Diabetes Research Institute

People needed

25

Starts

2019-05-10

Expected to finish

2020-02-25

Last updated by the study team

2021-09-05

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

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),
• 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

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.

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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