Community-based Screening for Diabetes Using a Validated Point-of-care HbA1c Assay in a British Columbia First Nations Community
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Does the HbA1c identify the same individuals as fasting and 2-hr pc glucose tests to identify diabetes and pre-diabetes in a First Nation community
研究概览
简要总结
- Purpose
- to estimate the prevalence of undiagnosed diabetes mellitus and pre-diabetes in a BC First Nation community
- to determine the utility of community based screening by examining how many positively screened people follow up with the recommended subsequent testing and family physician visit
- to determine if point-of-care HbA1c test (Ames/Bayer DCA 2000) correlates with the confirmatory fasting and 2 hour post challenge blood glucose tests.
- Hypothesis The Point-of-Care test will correlate well with the gold standard diagnostic tests and prove to be a useful tool for community-based screening. This test obviates the need for fasting and repeat glucose tolerance testing.
详细描述
This is a screening for prevalence study.
The Seabird Island Band's health department serves a large catchment area of approximately 3000 First Nation members. The team of physicians, nurses, and technicians will invite communities to participate in diabetes screening events. In conjunction with the community health workers, we will be facilitating diabetes awareness in the community through the provision of large scale screening Two types of events will be held. An initial "Open House" event and a second event in the form of an afternoon "Diabetes Awareness" event later in the year.
With the assistance of community leaders and the Seabird Island Health Unit staff, we will utilize materials such as posters and flyers available from the Health unit both to increase awareness of diabetes and to advise of the awareness/screening events. For the Community Event there will be a community dinner served at the end of the afternoon for all who attended.
Community members of Seabird Island will be invited for screening through posters hung in gathering spaces and high traffic areas. Notices will be put in the community newsletter.
They will be given information about the screening study and will give informed consent by way of a formal consent form. If younger than 18, consent will be obtained from parents or guardians. Identity will be concealed by using study numbers for individuals; a master list linking names and PHNs to the study numbers will be kept by the Seabird Island lead for the study at Seabird Island in a locked cabinet in a locked office. Primary and Co-investigators will receive only anonymized data. This is the wish of the community and is in keeping with OCAP principles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Members of Seabird Island or surrounding communities
- •self-identified as First Nation1
- •14 years old and older
排除标准
- •Known diabetes
- •age less than fourteen years old
- •pregnancy or less than six weeks post-partum
- •medications known to interfere with glucose metabolism
- •acute illness,
- •life-expectancy of less than six months
结局指标
主要结局
Does the HbA1c identify the same individuals as fasting and 2-hr pc glucose tests to identify diabetes and pre-diabetes in a First Nation community
时间窗: One Month between individual comparative samples; One year for recruitment of all subjects.
We will obtain A1c, fasting glucose, and 2 hour post glucose drink glucose tests in First Nation volunteers. An A1c result of 6-6.4% will be considered diagnostic of pre-diabetes, a result ≥6.5% diabetes, a fasting glucose of 6.1-6.9 mmol/L pre-diabetes, and a fasting glucose ≥7 mmol/L, diabetes. Individual A1c results will be compared to fasting and 2 hour post glucose drink results. We will determine the sensitivity and specificity of the A1c test compared to the fasting and post glucose drink glucose tests.
次要结局
- Provide estimates of prevalence of diabetes and prediabetes in a First Nation community(One year)
- To identify the response rate of "gold standard" diabetes testing in a First nation community(One Year)