NCT01669616

Brief Summary

The primary objective of the trial is to collect SCOUT DS, random capillary glucose and Hemoglobin A1c measurements from subject 18 years of age or older.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

5 months

First QC Date

July 23, 2012

Last Update Submit

January 13, 2013

Conditions

Diabetes Mellitus, Non-Insulin Dependent

Keywords

Type 2 DiabetesAdults 18 years and older

Outcome Measures

Primary Outcomes (1)

  • To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia.

    one week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Attendees of Blue Cross Blue Shield Wellness Event

You may qualify if:

  • years of age or older

You may not qualify if:

  • Known to be pregnant (self-reported)
  • Receiving dialysis or known renal compromise
  • Known to have photosensitivity
  • Taking medications that fluoresce
  • Have scars, any tattoos, rashes or other disruption/discoloration on the left volar forearm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blue Cross Blue Shield of Louisiana

Baton Rouge, Louisiana, 70809, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Andrea Barrack, MD

    Blue Cross Blue Shield of Louisiana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2012

First Posted

August 21, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

US(1)