Status:
COMPLETED
Diabetes Pueblo Program - Application and Acceptability of Culturally Appropriate Latino Education for Insulin Therapy
Lead Sponsor:
Sansum Diabetes Research Institute
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Type2 Diabetes
Eligibility:
All Genders
19+ years
Phase:
NA
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 T...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04016584
Start Date
May 10 2019
End Date
February 25 2020
Last Update
September 5 2021
Active Locations (1)
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1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93463