Study of a Culturally Tailored Diabetes Education Curriculum With Real-time Continuous Glucose Monitoring in a Latinx Population With Type 2 Diabetes (The CUTDM With CGM Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
Determine the impact of the Compañeros en Salud (Partners in Health) curriculum in conjunction with RT-CGM on glycemic control in Latinx patients with T2D. Participants will be randomized to receive the Companeros en Salud diabetes self-management education and support (DSMES) intervention with or without RT-CGM
详细描述
The prevalence of type 2 diabetes is increasing especially in the Latinx community and in family members of those already living with diabetes. Diabetes education is a cornerstone of treatment but is often not culturally tailored and there is limited data on benefit of virtual delivery of sessions. Real Time Continuous glucose monitoring is a tool to improve diabetes but is not readily available to those living with type 2 diabetes not on multiple doses of insulin. Furthermore here is little to no data on RT-CGM use in different minority populations. Data is also lacking on if diabetes education for an individual affects the family unit. We hypothesize that culturally tailored Diabetes self-management education using and support (DSMES) using a team approach of health educators and Community health workers will improve glycemic indices. We further hypothesis that RT-CGM coupled to DSMES will enhances glycemic benefit and change nutrition and activity behaviors. This will be a randomized control trial of 100 Latinx participants who will all receive culturally tailored DSMES with or without cycle RT-CGM over 12 weeks. Primary outcome will be mean A1C improvement at 12 and 24 weeks based on attendance of sessions and RT-CGM use. Secondary outcomes will be satisfaction with education and CGM, changes in weight, blood pressure and self-reported nutrition and exercise changes. This study will be the first study to examine how DSMES with and without RT-CGM use improves health outcomes in the Latinx population and their families
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants adults 18-60 years old
- •Self-identify as Latinx
- •Have had a clinical diagnosis of T2D within the last 15 years with or without medication use
- •Have an A1C ≥8.0% at screening
- •Own or have routine access to a personal device that allows attending educational sessions virtually
- •Be physically and cognitively able to use the home CGM monitoring device
- •Be willing and able to follow all other study procedures
- •Exclusion Criteria
- •Exclusion Criteria.
- •Duration of diabetes >15 years
- •Type 1 diabetes or latent autoimmune diabetes
- •Current use of prandial insulin
- •Any condition that prevents walking at least 1 city block
- •History of serious mental illness other than adequately treated depression
- •History of bariatric surgery or current participation in a weight management program
- •Current diagnosis of cancer or other serious or systemic medical condition
- •Significant active cardio- or cerebrovascular disease after review by PI
- •know history x of of hypoglycemia unawareness
- •Unable to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements
排除标准
- 未提供
结局指标
主要结局
Hemoglobin A1C
时间窗: change at 12 weeks
Percent change in A1C
次要结局
- International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES):(baseline)
- CGM Mean Glucose(12 weeks)
- CGM Percentage of Time in Range(12 WEEKS)
- Physical Activity Questionnaire IPAQ(12 weeks)
- Percent Change in BMI(change at 12 WEEKS)
- Blood Pressure Systolic(change at 12 WEEKS)
- International Physical Activity Prevalence Study SELF-ADMINISTERED ENVIRONMENTAL MODULE(PANES):(baseline)
- PHQ9 Depression Score- Those With PHQ9>15(12 weeks)
- PAID-5 Problem Areas in Diabetes Those With Score > 8(score at 12 weeks)
- Self-care for Diabetes (SDSCA) Number of Days Reporting Self Care(composite score at 12 weeks)
- Modified Joslin Diabetes Center CGM Experience(12 weeks)
- Perception of Behavior Modification After Real-Time- CGM Use(at 12 weeks)
- Household/Family Member Perception of Lifestyle Changes(12 weeks)
- Pedometer(at 12 weeks)
- Self-Efficacy for Diabetes(score at 12 weeks)
- Food Insecurity Short Form 6 Question Composite With Score Reported as a Composite: High or Marginal Food Security, Low Food Security, Very Low Food Security(baseline)
研究者
Nicole Ehrhardt
Assistant Professor of Medicine
University of Washington