Using the FreeStyle Libre system to monitor blood glucose in insulin-treated patients undergoing dialysis
| ISRCTN | ISRCTN79538756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79538756 |
| IRAS number | 251963 |
| Secondary identifying numbers | ADC-UK-PMS-18038 |
- Submission date
- 16/11/2018
- Registration date
- 10/12/2018
- Last edited
- 21/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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 (UK)
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
Contact information
Public
Range Road
Witney
OX29 0YL
United Kingdom
Study information
| Study design | Interventional prospective multi-centre single-arm pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | FreeStyle Libre flash glucose monitoring system use in insulin-treated patients undergoing dialysis: a pilot study |
| Study acronym | FLUIDS |
| Study objectives | 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(s) | NRES Committee: Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, 08/10/2018, 18/YH/0398 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Masked FreeStyle Libre Glucose Monitoring Sensor |
| 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 study start date | 01/09/2018 |
| Completion date | 05/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 26 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 13/12/2018 |
| Date of final enrolment | 30/03/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
OX3 9DU
United Kingdom
B15 2WB
United Kingdom
Sponsor information
Industry
Range Road
Witney
OX29 0YL
United Kingdom
"ROR" |
https://ror.org/03wnay029 |
|---|
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 21/11/2024: There is no longer a plan to publish the results in a journal. Previous publication and dissemination plan: Possible presentation at a diabetes conference, and/or publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Pamela Reid (Pamela.reid@abbott.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | 21/11/2024 | 21/11/2024 | No | No |
Additional files
Editorial Notes
21/11/2024: Basic results and total final enrolment added. Publication and dissemination plan updated.
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.
