NCT01346046

Brief Summary

The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

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

April 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

April 28, 2011

Last Update Submit

December 3, 2012

Conditions

Diabetes Mellitus, Non-Insulin Dependent

Keywords

Type 2 DiabetesAdults 18 years and olderTaking Control of Your Diabetes Health Fair

Outcome Measures

Primary Outcomes (1)

  • Continuing validation of SCOUT DS algorithm

    Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes

    1 day

Study Arms (2)

Those with Type 2 diabetes

270 subjects with Type 2 diabetes

Non diabetic

30 healthy subjects

Eligibility Criteria

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

Attendees of the Taking Control of Your Diabetes Health Fair, Albuquerque Convention Center

You may qualify if:

  • Age greater than or equal to 18 years Self-reported diagnosis of type 2 diabetes No Self-reported diagnosis of type 2 diabetes

You may not qualify if:

  • Less than 18 years of age
  • Diagnosed with type 1 diabetes
  • Known to be pregnant (Self Reported)
  • Receiving dialysis or having known renal compromise
  • Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
  • Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albuquerque Convention Center

Albuquerque, New Mexico, 87102, 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

  • Walter Forman, MD

    Lovelace Scientific Resources

    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

April 28, 2011

First Posted

May 2, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

US(1)