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临床试验/NCT03799796
NCT03799796已完成不适用

Combining Flash Glucose Monitoring and Online Peer Support to Improve Outcomes in Hispanic Spanish-Speaking People With Type 2 Diabetes

University of Utah2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Time-in-Range

研究概览

简要总结

Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management, including healthy eating and being physically active in Hispanic Spanish-speaking individuals. Use of diabetes technology is on the rise, however, many technologies do not provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in both English and Spanish. Research suggests that use of FGM results in improved clinical outcomes. Furthermore, increased number of FGM scans are associated with improved clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it supports Spanish language and (2) in English-speaking populations, but not specific to the Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work, and the work of others, indicate Hispanic individuals desire for peer interactions to relate and understand the variables that impact T2D. Interaction with online peer support communities is associated with increased knowledge, receipt of emotional support, and improved glycemic levels. These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.

详细描述

Currently, Hispanic Spanish-speaking individuals are not receiving culturally appropriate diabetes care. Lack of knowledge impacts several areas of type 2 diabetes (T2D) management, including healthy eating and being physically active in Hispanic Spanish-speaking individuals. Use of diabetes technology is on the rise, however, many technologies do not provide Spanish-language options. A flash glucose monitoring (FGM) system is now available in both English and Spanish. FGM involves wearing an interstitial glucose sensor that is placed on the upper arm and a reader. When an individual wants to check their glucose level, they waive or scan the reader over their sensor and a glucose history, current glucose level, and projected glucose trend is displayed. Research suggests that use of FGM results in improved clinical outcomes. Furthermore, increased number of FGM scans are associated with improved clinical outcomes such as decreased A1C and improvements in BG time in range. Our preliminary work indicates that Hispanics (1) are willing to use diabetes technology, such as FGM, if it supports Spanish language and (2) in English-speaking populations, but not specific to the Hispanic Spanish-speaking population, FGM supports biobehavioral change. Further, our work, and the work of others, indicate Hispanic individuals desire for peer interactions to relate and understand the variables that impact T2D. Interaction with online peer support communities is associated with increased knowledge, receipt of emotional support, and improved glycemic levels. These results suggest that education and support to increase use and understanding of FGM will lead to improved clinical and behavioral outcomes.

Little is known about the uses, benefits, and limitations of online peer support in the context of learning how to use diabetes technology, such as FGM. Hispanic, Spanish speaking individuals are at high risk for T2D and associated morbidity and mortality. Hispanics are more likely to die from diabetes compared to Caucasian counterparts. The investigators propose to address gaps in diabetes care for Hispanic individuals by conducting a pilot trial of an online peer support intervention using an online peer facilitator to augment the use of FGM. The online peer facilitator will be Hispanic and bilingual in English and Spanish with substantial knowledge of diabetes and FGM. Our intervention is culturally appropriate to address the biobehavioral and biopsychosocial needs of Hispanic individuals. The investigators anticipate the additional support provided by the online peer facilitator will encourage healthy eating habits and physical activity behaviors in Hispanic individuals with T2D. Our research team is experienced with community-based participatory research in both diabetes online peer support communities and Hispanic populations using technology to support T2D.

Examining online peer support communities to augment diabetes care in Hispanic Spanish speaking individuals is a promising, exciting, and innovative area of research that has not yet been explored. This proposed study contains several novel components. First, using online peer support communities is low-cost and easily accessible, making this intervention more translatable in the clinical setting while adding to the toolkit that already exists for diabetes care. Second, using FGM in a population not using insulin is forward thinking. Empowering people with their own glucose data, early in the course of their diabetes, may change the trajectory of diabetes management. The research team received PCORI pipeline-to-proposal funding (tiers I-III) to develop a research question via a community advisory board (CAB) in partnership with the diabetes online peer support community. The CAB included researchers, clinicians, and people with diabetes, both English and Spanish speaking. This study will address important questions identified by people affected by diabetes.

Aim 1 Explore the relationship between engagement in an online peer support intervention with clinical and behavioral outcomes in Hispanic, Spanish speaking individuals with T2D using flash glucose monitoring for 12 weeks

Method. A one group, pre-post evaluation of Hispanic, Spanish speaking individuals (N=43) recruited from a health center in Utah.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥21 years
  • Self-report as Hispanic
  • Able to communicate in Spanish
  • Clinical diagnosis of T2D and HbA1c ≥8% per clinic records
  • Willing to wear a flash glucose monitor for 12 weeks
  • Access to the internet and willing to engage in an online peer support community
  • Willing to avoid Vitamin C 500 mg and Aspirin 325 mg or greater daily
  • Not using insulin

排除标准

  • Non-Spanish speaking
  • Using insulin
  • Already using a continuous glucose monitor or flash glucose monitor in previous 6 months
  • Participation in other diabetes clinical trials
  • Alcohol or drug abuse/dependency
  • Severe illness (physical or mental health), cognitive impairment, high dose steroids, hospitalized more than 2 times in past 12 months or other impairment that would, in the opinion of the investigators, interfere with ability to complete the study
  • Uncorrected hearing or vision impairment
  • Life expectancy <6 months

结局指标

主要结局

Time-in-Range

时间窗: 12 weeks

Average glucose level and number of minutes spent between 70-180 mg/dL

次要结局

  • A1C(12 weeks)
  • Online peer support engagement(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Litchman

Assistant Professor

University of Utah

研究点 (2)

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