Blood Glucose Monitoring System Clinical Study

Diabetes Clinical Trial

— BGMS  

Official title:

Blood Glucose Monitoring System Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327209
• Other study ID #: TP-0000145
• Status: Completed
• Phase: N/A
• First received: March 30, 2011
• Last updated: June 8, 2011
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: June 2011
• Source: Intuity Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Verify the following with blood glucose monitoring system:

• precision and accuracy versus YSI reference

• user evaluation

• labeling comprehension

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Inability to provide Informed Consent

• Subject does not meet Inclusion Criteria

• Subject does not agree to test for infectious diseases per clinical protocol

• Subject has minimally one positive test for any infectious disease listed under Exclusion Criteria per protocol

• Subject with any condition (in addition to those which are listed in the pre-screen Exclusion Criteria tests) which in the opinion of the Investigator may place the subject or site personnel at excessive risk

• Subject's physical condition/limitation prevents the person from using a BGMS on their own

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United States	University of Miami - School of Medicine	Miami	Florida
United States	Park Nicollett Institute - International Diabetes Center	Minneapolis	Minnesota
United States	Cetero Research DGD	San Antonio	Texas
United States	University of San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Intuity Medical, Inc

Country where clinical trial is conducted

United States,