Specialized Technology Education for Pumps & Pens in Underserved Populations With Diabetes
Public ClinicalTrials.gov record NCT04550585. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04550585
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Interventions
- Education: Session 1 - Basics of type 1 management Other
- Session 2 - Carbohydrate counting Other
- Education: Session 3 - Insulin self- adjustment Other
- Education: Session 4 - Sick day rules and physical activity dose adjustments Other
- Education: Session 5 - Starting the insulin pen (for pen users) or pump (for pump users) Other
- Education: Session 6 - Trouble shooting the pump (for pump users) Other
Other
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2017
- Primary completion
- Oct 30, 2019
- Completion
- Jul 30, 2020
- Last update posted
- Apr 23, 2023
2017 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California Eastside Center for Diabetes | Los Angeles | California | 90022 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04550585, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04550585 live on ClinicalTrials.gov.