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Project Frazier 3 Regulatory Clinical Evaluation

L

LifeScan

Status

Completed

Conditions

Healthy Volunteers
Diabetes Mellitus

Treatments

Device: Frazier 3 Verio
Device: Frazier 3 UltraPlus

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT03515421
3165622

Details and patient eligibility

About

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Full description

User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.

Enrollment

379 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Summary of Inclusion Criteria

  • Age - Subject is at least 12 years old.
  • Informed Consent - Subject reads the appropriate Participant Information Sheet and signs the Informed Consent Form (section 12.0).
  • Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
  • Language - Subject reads and understands local language
  • SMBG status confirmed
  • Subject agrees to complete all aspects of the study

Summary of exclusion criteria

  • Conflict of Interest
  • Pregnancy - Subject is pregnant (as confirmed by Subject)
  • User Performance Accuracy Testing - Technical Expertise

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

379 participants in 1 patient group

Blood Glucose monitoring System (BGMS)
Experimental group
Description:
Intervention: Blood Glucose monitoring Systems (BGMSs): Frazier 3 Verio and Frazier 3 UltraPLus. Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)
Treatment:
Device: Frazier 3 Verio
Device: Frazier 3 UltraPlus

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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