User performance evaluation of the FreeStyle Optium Blood Glucose Monitoring System

User performance evaluation of the FreeStyle Optium Blood Glucose Monitoring System: a multi-centre prospective single arm study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17191485

Enrollment

120

Registered

2015-08-17

Start date

2015-07-27

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Diabetes mellitus Nutritional, Metabolic, Endocrine

Interventions

1. A participant will perform a blood glucose measurement on the FreeStyle Optium Blood Glucose Monitoring System 2. A capillary blood sample will be collected to perform haemoglobin t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Type 1 or Type 2 Diabetes 2. Age = 16 years

Exclusion criteria

Exclusion criteria: 1. Currently using the FreeStyle Optium, Boots or Optium Xceed Blood Glucose Monitoring System for routine testing at home (as pictured in the PIIC) 2. Known to be infected with hepatitis B virus (Hep B), hepatitis C virus (Hep C) or human immunodeficiency virus (HIV) 3. Be a member of the study staff 4. Already participated in this study

Design outcomes

Primary

Measure	Time frame
Accuracy analysis will be performed according to ISO 15197:2013 Section 8.2 The analysis will be performed when the study is complete. ISO 15197:20131 section 8.2 specifies that at least 95% of fingerstick blood glucose results are required to be within ± 0.83 mmol/L (15mg/dL) / 15% of the reference analyser (YSI). Regression analysis will also be performed and plots of the data will be generated.	—

Measure

Time frame

Accuracy analysis will be performed according to ISO 15197:2013 Section 8.2 The analysis will be performed when the study is complete. ISO 15197:20131 section 8.2 specifies that at least 95% of fingerstick blood glucose results are required to be within ± 0.83 mmol/L (15mg/dL) / 15% of the reference analyser (YSI). Regression analysis will also be performed and plots of the data will be generated.

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Secondary

Measure	Time frame
Linear regression and error grid analysis.	—

Countries

England, United Kingdom

Contacts

Public ContactPamela Reid

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026