The primary objective is to identify compare SCOUT DS to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin A1c ≥ 6.0%.
The study will complete up to 330 subjects at the clinical site to evaluate the accuracy of SCOUT DS, random capillary glucose (RCG) and the Leicester diabetes risk questionnaire for detecting prediabetes and undiagnosed type 2 diabetes in subjects at risk, but not having a pre-exiting diagnosis of type 2 diabetes. A point of care A1c measurement (Siemens DCA Vantage or Axis-Shield Afinion) will serve as the reference method for defining a positive screen (A1c ≥ 6.0%).
Study Type
OBSERVATIONAL
Enrollment
330
Airedale General Hospital
Keighley, West Yorkshire, United Kingdom
RECRUITINGHemoglobin A1c
A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤6.4%) and diabetes (A1c ≥ 6.5%) The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months. The target cohort comprises persons at risk for pre-diabetes and/or type 2 diabetes.
Time frame: Up to 6 months
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