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

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.

Conditions

• Type1diabetes

Interventions

OTHER

Education: Session 1 - Basics of type 1 management

In a group education session, a diabetes educator provides educational session 1 - Basics of type 1 management. Accompanying educational guide: How Can I Manage My Type 1 Diabetes Better?

OTHER

Session 2 - Carbohydrate counting

In a group education session, a diabetes educator provides educational session 2 - Carbohydrate counting Accompanying educational guide: How Can I Manage My Type 1 Diabetes Better?

OTHER

Education: Session 3 - Insulin self- adjustment

In a group education session, a diabetes educator provides educational session 3 - Insulin self- adjustment Accompanying educational guide: How Can I Manage My Type 1 Diabetes Better?

OTHER

Education: Session 4 - Sick day rules and physical activity dose adjustments

In a group education session, a diabetes educator provides educational session 4 - Sick day rules and physical activity dose adjustments Accompanying educational guide: How Can I Manage My Type 1 Diabetes Better?

OTHER

Education: Session 5 - Starting the insulin pen (for pen users) or pump (for pump users)

In a group education session, a diabetes educator provides educational session 5 - Starting the insulin pen (for pen users) or pump (for pump users) Accompanying educational guide: Is the Insulin Pump Right for Me? How Do I Use an Insulin Pump? Is the Insulin Pen Right for Me?

OTHER

Education: Session 6 - Trouble shooting the pump (for pump users)

In a group education session, a diabetes educator provides educational session 6 - Trouble shooting the pump (for pump users) Accompanying educational guide: Is the Insulin Pump Right for Me? How Do I Use an Insulin Pump?

Sponsors & Collaborators

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• University of Southern California

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-01

Primary Completion

2019-10-31

Completion

2020-07-31

Countries

• United States

Study Locations