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NCT04550585 · ClinicalTrials.gov registry record
Specialized Technology Education for Pumps & Pens in Underserved Populations With Diabetes
A clinical trial, sponsored by University of Southern California.
- Completed
- Registry status
- 63
- Enrollment target
NCT04550585: Completed study, sponsored by University of Southern California.
NCT04550585 is a clinical trial that has completed, run by University of Southern California. The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04550585 has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
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.
Primary Outcome
Number of patients with decreased HbA1c as measured by point of care HbA1c level from baseline to 12 months
Interventions
- OTHER 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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2017-04-01 |
| Est. Completion | 2020-07-31 |
What the finished NCT04550585 record still lists
NCT04550585 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target.
The record links to 0 conditions, and to 5 interventions - of which Education: Session 1 - Basics of type 1 management is the first listed.
NCT04550585 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04550585 about?
NCT04550585 is a clinical study titled "Specialized Technology Education for Pumps & Pens in Underserved Populations With Diabetes". 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 designe...
What is the current status of trial NCT04550585?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2017-04-01. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT04550585?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT04550585?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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