Blood Glucose Monitoring System Clinical Study (BGMS)

Intuity Medical

Status: Completed

Conditions: Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT01327209

TP-0000145

Details and patient eligibility

About

Verify the following with blood glucose monitoring system:

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

Enrollment: 202 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

202 participants in 1 patient group

Patients with diabetes