Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/07/2015
Date assigned
17/08/2015
Last edited
17/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The FreeStyle Optium Blood Glucose Monitoring System is a system for measuring glucose levels and is freely available to buy on the market in the UK. The aim of the study is to evaluate whether at least 95% of FreeStyle Optium Blood Glucose Monitoring System results are required to be within ± 0.83 mmol/L (15mg/dL) / 15%.of the YSI reference measurement.

Who can participate?
Patients with diabetes and aged at least 16 years.

What does the study involve?
Participants first have an opportunity to familiarise themselves with the FreeStyle Optium System, before performing a blood glucose test from their fingertip. A capillary blood sample is collected to perform haemoglobin testing on the HemoCue analyser and a glucose reference test on the YSI analyser. This should take up no more than 30 minutes of each participants time.

What are the possible benefits and risks of participating?
There is no direct benefit to the participant by taking part in this study. The only risks associated with the study are capillary blood sample collection, these are small but could include pain, bruising, local infection and fainting.
Where is the study run from?
The Ipswich Hospital NHS Trust and Leeds Teaching Hospitals NHS Trust (UK)

When is the study starting and how long is it expected to run for?
July 2015 to October 2015

Who is funding the study?
Abbott Diabetes Care Ltd (UK)

Who is the main contact?
Dr Pamela Reid

Trial website

Contact information

Type

Public

Primary contact

Dr Pamela Reid

ORCID ID

Contact details

Range Road
Witney
OX29 0YL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ADC-UK-PES-15027

Study information

Scientific title

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

Acronym

Study hypothesis

The aim of the study is to evaluate whether at least 95% of FreeStyle Optium Blood Glucose Monitoring System results are required to be within ± 0.83 mmol/L (15mg/dL) / 15%.of the YSI reference measurement.

Ethics approval

NRES Committee South Central - Berkshire B, 23/06/2015, ref: 15/SC/0395

Study design

Multi-centre prospective single arm

Primary study design

Interventional

Secondary study design

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Diabetes mellitus

Intervention

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 testing on the HemoCue analyser and a glucose reference test on the YSI analyser

Intervention type

Device

Phase

Drug names

Primary outcome measures

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.

Secondary outcome measures

Linear regression and error grid analysis.

Overall trial start date

27/07/2015

Overall trial end date

30/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type 1 or Type 2 Diabetes
2. Age ≥ 16 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 participants

Participant 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

Recruitment start date

27/07/2015

Recruitment end date

11/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Ipswich Hospital NHS Trust
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

Leeds Teaching Hospitals NHS Trust
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

Abbott Diabetes Care

Sponsor details

Range Road
Witney
OX29 0YL
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Abbott Diabetes Care Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results of these studies are rarely of interest to scientific or medical publications but we will submit to an appropriate journal or meeting in 2016

Intention to publish date

01/07/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes