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

NCT04550585 | Completed

• 1 other identifier: STEPP-UP
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

low-literacy, diabetes education

Outcome Measures

Primary Outcomes (6)

• Low-literacy based education on HbA1c

  Number of patients with decreased HbA1c as measured by point of care HbA1c level from baseline to 12 months

  12-months

• Low-literacy based education on hypoglycemia

  Number of patients with decreased hypoglycemia as measured by self report from baseline to 12 months

  12 months

• Low-literacy based education on diabetic ketoacidosis

  Number of patients with decreased diabetic ketoacidosis as measured by self report from baseline to 12 months

  12 months

• Low-literacy based education on diabetes distress

  Number of patients with decreased diabetes distress as measured by Type 1 Diabetes Reducing Distress and Enhancing Effective Management diabetes distress scale from baseline to 12 months

  12 months

• Low-literacy based education on hypoglycemia fear

  Number of patients with decreased hypoglycemia fear as measured by the Hypoglycemia Fear Survey from baseline to 12 months

  12 months

• Low-literacy based education on diabetes knowledge

  Number of patients with increased as measured by the Simplified Diabetes Knowledge Test from baseline to 12 months

  12 months

Interventions

Education: Session 1 - Basics of type 1 management OTHER

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?

Session 2 - Carbohydrate counting OTHER

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?

Education: Session 3 - Insulin self- adjustment OTHER

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?

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

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?

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

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?

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

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?

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

English or Spanish speaking adults ages 18 to 75 with type 1 diabetes

You may qualify if:

• Diagnosis of type 1 diabetes
• Age 18 - 75 years old
• Currently being treated at the T1D clinic in the LAC/USC Healthcare System
• No use of CSII or insulin pen in the past 6 months
• No serious illnesses where life expectancy is \<1 year
• Understand the study requirements and agree to comply with all study visits and procedures.
• Fluent in English or Spanish

You may not qualify if:

• Subject is currently pregnant or lactating or plan on becoming pregnant during the course of the study.
• Subject is Blind
• Subject cannot follow instructions due to a medical condition or mental illness.
• Subject has a known allergy to medical adhesive.

Sponsors & Collaborators

• University of Southern California: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

University of Southern California Eastside Center for Diabetes

Los Angeles, California, 90022, United States

Location

Related Publications (1)

• Orrange S, Ruelas V, Peters AL. Specialized Technology Education for Pumps and Pens in Underserved Populations with Diabetes. Diabetes Technol Ther. 2022 Apr;24(4):268-275. doi: 10.1089/dia.2021.0265. Epub 2021 Dec 7.

  PMID: 34809482 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Clinical Scholar

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: April 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: July 31, 2020
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)