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临床试验/NCT06864728
NCT06864728进行中(未招募)不适用

The Impact of Social Determinates of Health on Risk for Diabetes in the Hispanic Community: a Pilot Study

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Diabetes Knowledge

研究概览

简要总结

The purpose of the study is twofold: to see the impact of your environmental stress on daily glucose changes and to create an intervention using CGM to potentially decrease risk for diabetes. The aim of this study to develop an intervention to prevent diabetes in the Hispanic community and inform policies about social determinants of health.

详细描述

Social determinants of health are associated with developing diabetes mellitus type 2 (diabetes) onset, progression, and adverse outcomes. Hispanics have a 50% lifetime risk of developing diabetes. They also transition from pre-diabetes to diabetes faster and have an earlier onset of diabetes and its complications than the general population. People with a family history of diabetes are 7.6 times more likely to develop diabetes than individuals without such a history. Diabetes research uses hemoglobin A1C (A1C), the accumulation of glucose on hemoglobin molecules during the past three months, as the measure of diabetes control. However, A1C is an insensitive measure of glucose for those at risk for developing diabetes because glucose spikes and variability are often masked in an average glucose level by A1C. Glucose spikes should rarely occur and can be an early indicator of insulin insufficiency. Constant glucose monitors (CGM) can detect glucose spikes and have successfully lowered A1C in people with diabetes.

Using CGM, Hispanic adults with familial risk factors of diabetes can obtain a more detailed assessment of their glucose levels and identify foods, activities, emotions, and stress that impact their glucose levels. Time constraints can often be a barrier to participating in an intervention. The proposed intervention will test an asynchronous nurse-led intervention. To address this gap and create an intervention, glucose variability in Hispanics at risk for diabetes will be investigate to identify glucose variability predictors and create a culturally tailored intervention to prevent diabetes.

Diagnosis of glucose intolerance, or prediabetes, can be evaluated using an oral glucose tolerance test (oGTT) to illustrate a person's ability to produce and use insulin in response to glucose consumption. The medical community uses these lab values as benchmarks. Knowing the starting level of participants' glucose tolerance will allow us to better interpret the CGM findings. Additionally, it will provide validity for using CGMs in the population at risk for diabetes.

Therefore, the specific aims are as follows:

  1. To examine the relationship between social determinants and glucose control. These analyses estimate the associations between economic instability, neighborhood vulnerability, food insecurity, and healthcare quality with glucose variability.
  2. To determine the feasibility and acceptability of a CGM intervention for Hispanics at risk of diabetes. The study compares synchronous or asynchronous diabetes education intervention. The participants will receive education and feedback based on their CGM results, either in person or via videos.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

No masking

入排标准

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

入选标准

  • •self- identify as Hispanic Has a parent diagnosed with diabetes type 2

排除标准

  • •Pregnant Type 1 diabetes

研究组 & 干预措施

In Person patient education

Active Comparator

Participants will receive patient education in person or virtually. They will get the results from their tests

干预措施: In person or virtual diabetes education (Behavioral)

Video Intervention

Experimental

Patients will receive a link to a video of a nurse explaining their results.

干预措施: Video Diabetes Education (Behavioral)

结局指标

主要结局

Diabetes Knowledge

时间窗: 4 weeks

measured by the Diabetes Knowledge questionnaire - Revised

次要结局

未报告次要终点

研究者

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

Julie Zuniga

Associate Professor

University of Texas at Austin

研究点 (1)

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