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Blood Glucose Monitoring System Clinical Study

Blood Glucose Monitoring System Clinical Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01327209
Acronym
BGMS
Enrollment
202
Registered
2011-04-01
Start date
2010-12-31
Completion date
2011-04-30
Last updated
2011-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

Verify the following with blood glucose monitoring system: * precision and accuracy versus YSI reference * user evaluation * labeling comprehension

Interventions

None listed

Sponsors

Intuity Medical, Inc
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026