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 glucose data using the FreeStyle Libre Pro Flash Glucose Monitoring System from adults with type 2 diabetes on oral glucose-lowering medication, with or without biphasic insulin
Who can participate?
Patients aged 18 and over with type 2 diabetes on oral glucose-lowering medication, or, oral glucose-lowering medication and biphasic insulin
What does the study involve?
Participants will wear two sensors for up to 14 days (glucose data is not visible during this time). Participants will return to the clinic where the sensors 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 from obtaining venous blood samples, these are small but could include pain, bruising, local infection and fainting. Data collected may be used to support future post-market clinical studies in this population
Where is the study run from?
1. Leeds Teaching Hospitals NHS Trust (Leeds)
2. Atherstone Surgery (Atherstone)
3. Westcliffe Medical Centre (Shipley)
4. Ashfields Primary Care Centre (Sandbach)
5. Kiltearn Medical Centre (Nantwich)
6. Eynsham Medical Group (Eynsham)
7. Trowbridge Health Centre (Trowbridge)
8. Beacon Medical Group (Plymouth)
9. Salford Royal NHS Foundation Trust (Salford)
When is the study starting and how long is it expected to run for?
Proposed start date 21/10/2019 to proposed end date 03/12/2019
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
Type
Public
Primary contact
Dr Pamela Reid
ORCID ID
Contact details
Abbott Diabetes Care
Range Road
Witney
OX29 0YL
United Kingdom
+44 (0)1993 863024
Pamela.Reid@abbott.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
ADC-UK-PMS-19044
Study information
Scientific title
Pilot Study to Assess use of FreeStyle Libre Pro with HbA1c in Determining Diabetes Management
Acronym
Study hypothesis
This pilot study is being conducted to determine whether understanding of diabetes status and management is better with use of HbA1c with FreeStyle Libre Pro than with HbA1c alone
Ethics approval
Approved 07/10/2019, NRES Committee: East Midlands – Nottingham 2 Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS; +44 (0)207 104 8035; NRESCommittee.eastmidlands-nottingham2@nhs.net), ref: 19/EM/0304, IRAS Project ID: 271103
Study design
Prospective open-label multi-centre single-arm pilot study in both hospital and GP practice settings
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Diabetes Mellitus (Diabetes)
Intervention
Participants will wear two FreeStyle Libre Pro Flash Glucose Monitoring Sensors for up to 14 days. There is no follow-up period unless the participant experiences an unanticipated adverse device effect (UADE).
Healthcare professionals will complete questionnaires using the HbA1c results alone and also using HbA1c results and the reports generated from the FreeStyle Libre Pro system.
Two sensors are to be applied to allow data collection to continue in case one sensor becomes detached during the study.
Intervention type
Device
Phase
Not Applicable
Drug names
FreeStyle Libre Pro Flash Glucose Monitoring Sensor
Primary outcome measure
Responses to HCP questionnaire using HbA1c results alone
Responses to a second questionnaire using HbA1c results and the reports generated from the FreeStyle Libre Pro system
Secondary outcome measures
Glycaemic measures, measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the two-week study duration.
1. Time in hypoglycaemia (<3.9 mmol/L)
2. Time in hyperglycaemia (>10.0 mmol/L)
3. Time in range (3.9-10.0 mmol/L)
4. Mean glucose, SD glucose and CV glucose
Overall trial start date
01/08/2019
Overall trial end date
23/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age at least 18 years
2. Type 2 diabetes, on oral glucose-lowering medication, or, oral glucose-lowering medication and biphasic insulin
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Total final enrolment
44
Participant exclusion criteria
1. Currently prescribed basal insulin
2. Currently prescribed bolus insulin
3. Currently prescribed glucagon-like peptide 1 (GLP-1) without being prescribed biphasic insulin
4. Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition
5. Has a pacemaker or any other neurostimulators
6. Currently receiving dialysis treatment or planning to receive dialysis during the study
7. Women who are pregnant, plan to become pregnant or become pregnant during the study
8. Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management
9. Known (or suspected) allergy to medical grade adhesives
10. In the investigator’s opinion the participant is unsuitable to participate due to any other cause/reason
Recruitment start date
21/10/2019
Recruitment end date
09/12/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Teaching Hospitals NHS Trust
LS9 7TF
United Kingdom
Trial participating centre
The Atherstone Surgery
CV9 1EU
United Kingdom
Trial participating centre
Westcliffe Medical Centre
BD18 3EE
United Kingdom
Trial participating centre
Ashfields Primary Care Centre
CW11 1EQ
United Kingdom
Trial participating centre
The Kiltearn Medical Centre
CW5 5NX
United Kingdom
Trial participating centre
Eynsham Medical Group
OX29 4QB
United Kingdom
Trial participating centre
Trowbridge Health Centre
BA14 8QA
United Kingdom
Trial participating centre
Beacon Medical Group
PL7 1AD
United Kingdom
Trial participating centre
Salford Royal NHS Foundation Trust
M6 8HD
United Kingdom
Sponsor information
Organisation
Abbott Diabetes Care Ltd
Sponsor details
Range Road
Witney
OX29 0YL
United Kingdom
+44 (0)1993 863024
Pamela.Reid@abbott.com
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. Estimated timeline is one year from trial end date.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Pamela Reid.
Intention to publish date
23/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list