Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/10/2019
Date assigned
14/10/2019
Last edited
14/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer 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 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

31/12/2019

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

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

03/12/2019

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

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/10/2019: Trial’s existence confirmed by HRA and HCRW.