Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/05/2019
Date assigned
22/05/2019
Last edited
22/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
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 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

N/A

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

Publication citations

Additional files

Editorial Notes

21/05/2019: Trial's existence confirmed by the South West - Cornwall & Plymouth Research Ethics Committee.