Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/11/2018
Date assigned
10/12/2018
Last edited
02/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
Pamela.reid@abbott.com

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-PMS-18038

Study information

Scientific title

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

Acronym

FLUIDS

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Diabetes mellitus (type 1 or type 2)

Intervention

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

Device

Phase

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

01/09/2018

Overall trial end date

05/03/2019

Reason abandoned (if study stopped)

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

25

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

13/12/2018

Recruitment end date

30/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospital
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Birmingham
B15 2WB
United Kingdom

Sponsor information

Organisation

Abbott Diabetes Care Ltd

Sponsor details

Range Road
Witney
OX29 0YL
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Abbott Diabetes Care

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)

Location

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 (Pamela.reid@abbott.com).

Intention to publish date

30/03/2020

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.