Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background & study aims
Diabetes is a lifelong condition where the amount of sugar in the blood is too high. The aim of this pilot study is to collect performance data on the masked FreeStyle Libre Flash Glucose Monitoring System with adults with type 1 or 2 diabetes on haemodialysis. FreeStyle Libre Flash Glucose Monitoring System is a device designed for people with diabetes to monitor their blood sugar.

Who can participate?
Patients aged 18 and over with type 1 or 2 diabetes on haemodialysis

What does the study involve?
Participants will wear a masked Sensor for up to 14 days. Participants will be requested to obtain four fingerprick BG readings per day whilst wearing the Sensor (using the built-in test strip port in the Reader). Participants will be asked to scan the Sensor with the Reader at the same time as each fingerprick BG test, and at regular intervals.
Participants will return to the clinic for Visit 2 where the Sensor will be removed and data uploaded.

What are the possible benefits & 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. Data collected may be used to support future pivotal trial designs in this population.

Where is the study run from
Churchill Hospital, Oxford & Queen Elizabeth Hospital, Birmingham

When is the study starting and how long is it expected to run for?
November 2018 to March 2019

Who is funding the study?
The study is funded by Abbott Diabetes Care Ltd

Who is the main contact?
Dr Pamela Reid

Trial website

Contact information



Primary contact

Dr Pamela Reid


Contact details

Range Road
OX29 0YL
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

FreeStyle Libre flash glucose monitoring system use in insulin-treated patients undergoing dialysis: a pilot study



Study hypothesis

Determining whether the performance of the FreeStyle Libre system is different when used by people with diabetes undergoing haemodialysis vs data previously collected on the non-dialysis diabetes population.

Ethics approval

NRES Committee: Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, 08/10/2018, 18/YH/0398, IRAS Project ID: 251963

Study design

Interventional prospective multi-centre single-arm pilot study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

No participant information sheet available


Diabetes mellitus (type 1 or type 2)


Participants will wear a Masked FreeStyle Libre Glucose Monitoring Sensor for 14 days and perform four fingerprick readings per day for each day of sensor wear using the built-in test strip port. There is no follow-up period unless the participant experiences an adverse device effect.

Intervention type



Drug names

Primary outcome measure

1. The accuracy of the system will be measured for the duration the subject is wearing the device (up to 14 days). Each blood glucose result recorded on the reader will be paired with the nearest Sensor glucose result.
2. The safety of the device in the diabetic population sub-group will be measured using the number and percentage of participants experiencing adverse events during the study from the point of consent until the end of the study.

Secondary outcome measures


Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Aged 18 years or over
2. Type 1 or type 2 diabetes
3. Requiring insulin therapy
4. Willing and able to test their blood glucose levels via fingerprick at least four times a day using the FreeStyle Libre System
5. In the investigator’s opinion, technically capable of using the study device
6. On stable haemodialysis (i.e. treatment using dialysis has been in progress for a minimum of 90 days)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Concomitant disease or condition that may compromise patient safety including and not limited to cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition
2. Currently prescribed oral steroid therapy for any acute or chronic condition
3. Female participant known to be pregnant
4. Have a pacemaker or any other neurostimulators
5. Known (or suspected) allergy to medical grade adhesives
6. In the investigator’s opinion, is unsuitable to participate due to any other reason

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospital
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
B15 2WB
United Kingdom

Sponsor information


Abbott Diabetes Care Ltd

Sponsor details

Range Road
OX29 0YL
United Kingdom

Sponsor type




Funder type


Funder name

Abbott Diabetes Care

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)


United States of America

Results and Publications

Publication and dissemination plan

Possible presentation at a diabetes conference, and/or publication in a peer-reviewed journal.

IPD sharing statement: The datasets generated during and/or analysed during the current study will be available upon request from Pamela Reid (

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/07/2019: The following changes have been made: 1. The recruitment start date has been changed from 30/11/2018 to 13/12/2018. 2. The overall trial end date has been changed from 30/03/2019 to 05/03/2019. 18/12/2018: Internal review.