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 using pre-mixed (biphasic) insulin.
Who can participate?
Patients aged 18 and over with type 2 diabetes using pre-mixed (biphasic) insulin and an HbA1c less than 7.5% (58 mmol/mol).
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 for Visit 2 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 pivotal clinical study designs in this population.
Where is the study run from?
1. Royal Derby Hospital, Derby
2. Royal Berkshire Hospital, Reading
3. Royal Blackburn Hospital, Blackburn
4. Ninewells Hospital, Dundee
5. Royal Infirmary of Edinburgh, Edinburgh
6. Hathaway Medical Centre, Chippenham
7. Kiltearn Medical Centre, Nantwich
8. Ashfields Primary Care Centre, Sandbach
9. Claremont Medial Practice, Exmouth
10. Albany House Medical Centre, Wellingborough
11. Eynsham Medical Group, Eynsham
12. The Adam Practice, Hamworthy
When is the study starting and how long is it expected to run for?
28/05/2019 to 31/07/2019
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
Abbott Diabetes Care
Range Road
Witney
OX29 0YL
United Kingdom
+44 1993 863024
Pamela.Reid@abbott.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
ADC-UK-PMS-19040
Study information
Scientific title
Pilot study to determine Time in HYpoglycaemia when using pre-MixEd (biphasic) insulin
Acronym
THYME
Study hypothesis
This pilot study is being conducted to determine the amount of time spent in low glucose or hypoglycaemia (less than 3.9 mmol/L [70 mg/dL]) by people with type 2 diabetes when using pre-mixed (biphasic) insulin.
Ethics approval
Approved 17/05/2019, NRES Committee: South West – Cornwall and Plymouth Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; 0207 104 8048; nrescommittee.southwest-cornwall-plymouth@nhs.net), ref: 19/SW/0086.
Study design
Prospective, multi-centre, single arm, pilot study in both hospital and GP practice settings.
Primary study design
Interventional
Secondary study design
Single-arm pilot study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available.
Condition
Type 2 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 (ADE).
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Time in hypoglycaemia (<3.9 mmol/L [70 mg/dL]), measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the two-week study duration.
Secondary outcome measures
Other glycaemic measures such as time in range (3.9-10.0 mmol/L [70-180 mg/dL]), measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the two-week study duration.
Overall trial start date
01/01/2019
Overall trial end date
31/07/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or over.
2. Type 2 diabetes treated with pre-mixed (biphasic) insulin for at least 6 months prior to study enrolment.
3. Most recent HbA1c less than 7.5% (58 mmol/mol), recorded in medical notes in last 12 months.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Currently prescribed animal insulin.
2. 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.
3. Has a pacemaker or any other neurostimulators.
4. Currently receiving dialysis treatment or planning to receive dialysis during the study.
5. Women who are pregnant, plan to become pregnant or become pregnant during the study.
6. Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
7. Known (or suspected) allergy to medical grade adhesives.
8. In the investigator’s opinion, unsuitable to participate due to any other cause/reason.
Recruitment start date
28/05/2019
Recruitment end date
15/07/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Derby Hospital
DE22 3NE
United Kingdom
Trial participating centre
Royal Berkshire Hospital
RG1 5AN
United Kingdom
Trial participating centre
Royal Blackburn Hospital
BB2 3HH
United Kingdom
Trial participating centre
Ninewells Hospital
DD1 9SY
United Kingdom
Trial participating centre
Royal Infirmary of Edinburgh
EH16 4SA
United Kingdom
Trial participating centre
Hathaway Medical Centre
SN14 6GT
United Kingdom
Trial participating centre
Kiltearn Medical Centre
CW5 5NX
United Kingdom
Trial participating centre
Ashfields Primary Care Centre
CW11 1EQ
United Kingdom
Trial participating centre
Claremont Medial Practice
EX8 2JF
United Kingdom
Trial participating centre
Albany House Medical Centre
NN8 4RW
United Kingdom
Trial participating centre
Eynsham Medical Group
OX29 4QB
United Kingdom
Trial participating centre
The Adam Practice
BH15 4JQ
United Kingdom
Sponsor information
Organisation
Abbott Diabetes Care Ltd
Sponsor details
Range Road
Witney
OX29 0YL
United Kingdom
+44 1993 863164
Joe.Bugler@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
31/07/2020
Participant level data
Available on request
Basic results (scientific)
Publication list