Specialized Technology Education for Pumps & Pens in Underserved Populations With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Low-literacy based education on diabetic ketoacidosis
研究概览
简要总结
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.
详细描述
SUMMARY OF STUDY RATIONAL - Lower socioeconomic status (SES) individuals with type 1 diabetes (T1D) 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. Until recently many of these lower SES individuals did not have access to health insurance, but with the implementation of the Affordable Care Act the group with the greatest expansion of coverage is the young adult age group (ages 18 - 34), particularly in the Latino community. Increased insurance allows for access to newer technology including insulin pens and pumps. As these patients have not had access to such devices, low literacy educational tool are necessary for safe and efficient utilization. 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 (LAC) healthcare system. This study is a single center pilot study and by the nature of our clinic setting it cannot be a randomized controlled trial - it is more of a naturalistic experiment comparing each patient to their prior state of glycemic control with their status after the educational intervention using low-literacy educational materials has been applied.
INTERVENTION - Baseline Visit: Participants will sign informed consent, complete questionnaires, and measure HbA1C. Those opting to do so will start a continuous glucose monitor (CGM) sensor. All patients will be provided the written low literacy teaching tools in the language of their choice.
CGM Visit - for those opting to wear CGM will occur at Week 2 where 14 days of CGM data will be downloaded from participants' device.
Education Sessions: Educational sessions will be conducted using the low-literacy tools we created. Classes will be available on Fridays during T1D Clinic and on Saturdays to maximize participation. Classes will be every two weeks for approximately 3 months. Classes will be approximately 1 ½ hours in duration. Patients will be encouraged but not required to attend the classes. However, those starting on the pen and/or pump will be asked to attend the relevant sessions to prepare them for use of the technology.
Educational Sessions:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Low-literacy based education on diabetic ketoacidosis
时间窗: 12 months
Number of patients with decreased diabetic ketoacidosis as measured by self report from baseline to 12 months
Low-literacy based education on diabetes knowledge
时间窗: 12 months
Number of patients with increased as measured by the Simplified Diabetes Knowledge Test from baseline to 12 months
Low-literacy based education on HbA1c
时间窗: 12-months
Number of patients with decreased HbA1c as measured by point of care HbA1c level from baseline to 12 months
Low-literacy based education on hypoglycemia
时间窗: 12 months
Number of patients with decreased hypoglycemia as measured by self report from baseline to 12 months
Low-literacy based education on diabetes distress
时间窗: 12 months
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
Low-literacy based education on hypoglycemia fear
时间窗: 12 months
Number of patients with decreased hypoglycemia fear as measured by the Hypoglycemia Fear Survey from baseline to 12 months
次要结局
未报告次要终点
研究者
Anne Peters
Professor of Medicine, Clinical Scholar
University of Southern California