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
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
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