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Specialized Technology Education for Pumps & Pens in Underserved Populations With Diabetes

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clinicaltrials.gov/study/NCT04550585
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT045505850
Trial Recruitment Size
630
Trial Sponsor
University of Southern California
University of Southern California
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Trial Collaborator
‌
The Leona M. and Harry B. Helmsley Charitable Trust
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Clinical Trial Start Date
April 1, 2017
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Primary Completion Date
October 31, 2019
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Study Completion Date
July 31, 2020
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Other0
Observational Study Perspective
Prospective0
Official Name
Specialized Technology Education for Pumps & Pens in Underserved Populations With Diabetes0
Last Updated
April 24, 2023
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Study summary

Lower socioeconomic status (SES) individuals with type 1 diabetes have poorer outcomes than wealthier patients and part of this disparity comes from a lack of tools and knowledge about how to teach these patients on the technologies other patients take for granted. Therefore, this is a study designed to develop and test low literacy English/Spanish language teaching tools for patients with type 1 diabetes treated with varying types of technology in the Los Angeles County healthcare system. The aims are to:To reduce health disparities for underserved adults with diabetes on multiple daily injection (MDI) therapy using vials and syringes through the use of a simplified lower literacy, culturally and language appropriate approach to teach, implement and follow these individuals started on insulin pens and pumps/continuous subcutaneous insulin infusion (CSII); To show no increase in rates of diabetic ketoacidosis (DKA) or severe hypoglycemia when using CSII or pen therapy compared to baseline rates; To reduce time spent in hyper and hypoglycemic ranges, as well as glycemic variability, as measured by blinded continuous glucose monitoring (CGM); Reduce psychological distress due to diabetes and improve health-related quality of life, as measured by validated distress and quality of life scales. Secondary Aims include: Reduction in A1C levels with CSII/pen therapy compared to standard MDI treatment; and to perform a cost-analysis of the process of implementation to improve the generalizability of the model.

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