Trials / Unknown
UnknownNCT01634997
Evaluation of SCOUT DS Device in the Diagnosis of Diabetes
An Evaluation of the SCOUT DS Device. Random Capillary Glucose and Leicester Diabetes Risk Score for Screening Subjects at Risk for Type 2 Diabetes
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 330 (estimated)
- Sponsor
- VeraLight, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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%.
Detailed description
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%).
Conditions
Timeline
- Start date
- 2012-06-01
- First posted
- 2012-07-06
- Last updated
- 2012-07-06
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01634997. Inclusion in this directory is not an endorsement.