Blood Glucose Monitoring System Clinical Study
BGMS
1 other identifier
observational
202
1 country
4
Brief Summary
Verify the following with blood glucose monitoring system:
- precision and accuracy versus YSI reference
- user evaluation
- labeling comprehension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJune 9, 2011
June 1, 2011
March 30, 2011
June 8, 2011
Conditions
Study Arms (1)
Patients with diabetes
Eligibility Criteria
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
University of Miami - School of Medicine
Miami, Florida, 33136, United States
Park Nicollett Institute - International Diabetes Center
Minneapolis, Minnesota, 55416, United States
Cetero Research DGD
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Bergenstal, MD
Park Nicollett Institue - International Diabetes Center
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