NCT01327209

Brief Summary

Verify the following with blood glucose monitoring system:

  • precision and accuracy versus YSI reference
  • user evaluation
  • labeling comprehension

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

June 9, 2011

Status Verified

June 1, 2011

First QC Date

March 30, 2011

Last Update Submit

June 8, 2011

Conditions

Study Arms (1)

Patients with diabetes

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who have been diagnosed with diabetes and are testing their blood glucose level at least once per day.

You may qualify if:

  • Be diagnosed with Diabetes
  • Be between 12 and 70 years of age
  • Be able to read, write, and understand English
  • Be able and willing to give Informed Consent
  • Have used an SMBG meter system for at least one year
  • Be currently testing blood glucose levels at least once per day

You may not qualify if:

  • Inability to provide Informed Consent
  • Subject does not agree to test for infectious diseases per clinical protocol
  • Subject's physical condition/limitation prevents the person from using a BGMS on their own

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of San Diego

San Diego, California, 92161, United States

Location

University of Miami - School of Medicine

Miami, Florida, 33136, United States

Location

Park Nicollett Institute - International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Cetero Research DGD

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Richard Bergenstal, MD

    Park Nicollett Institue - International Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2011

First Posted

April 1, 2011

Study Start

December 1, 2010

Study Completion

April 1, 2011

Last Updated

June 9, 2011

Record last verified: 2011-06

Locations