Plain English Summary
Background & study aims
The number of people with diabetes continues to rise throughout the world. In addition, there has been a similar rise in impaired glucose tolerance or prediabetes, which is a risk factor for developing type 2 diabetes. The aim of this pilot study is to collect glucose data using the FreeStyle Libre Pro Flash Glucose Monitoring System from adults with impaired glucose tolerance.
Who can participate?
Patients aged 18 and over with an HbA1c of 5.7-6.4% (39-47 mmol/mol).
What does the study involve?
Participants will wear two FreeStyle Libre Pro Sensors for up to 14 days (glucose data is not visible during this time). Participants will also be supplied with a fitness tracker and a tablet; an app will be pre-installed on the tablet and participants will be requested to record dietary intake for three days.
Participants will return to clinic for Sensor removal and data upload (Sensor and tracker), they will then wear a FreeStyle Libre Sensor for up to 14 days (glucose data will be visible during this time). Participants will be requested to complete a questionnaire at the end of the study.
What are the possible benefits & risks of participating?
The study gives participants with impaired glucose tolerance the opportunity to experience sensor technology using the FreeStyle Libre Pro and FreeStyle Libre Systems. 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 inform future pivotal clinical study designs in this population.
Where is the study run from?
1. Hathaway Medical Centre, Chippenham
2. Claremont Medial Practice, Exmouth
3. Albany House Medical Centre, Wellingborough
4. The Adam Practice, Hamworthy
5. Atherstone Surgery, Atherstone
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
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-19041
Study information
Scientific title
A pilot study to determine glycaemic variability in people with impaired glucose tolerance (prediabetes)
Acronym
SAGE
Study hypothesis
This pilot study is being conducted to determine the amount of glycaemic variability (measured by %CV glucose) in people with impaired glucose tolerance (prediabetes).
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/0087.
Study design
Prospective, multi-centre, single arm, pilot study
Primary study design
Interventional
Secondary study design
Single-arm pilot study
Trial setting
GP practices
Trial type
Other
Patient information sheet
No participant information sheet available.
Condition
Impaired Glucose Tolerance
Intervention
Participants will wear two FreeStyle Libre Pro Flash Glucose Monitoring Sensors for up to 14 days, followed by FreeStyle Libre for up to 14 days. During the Libre Pro sensor wear, participants will wear a fitness tracker (throughout the two weeks) and record dietary intake (for three 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
Glycaemic variability (%CV glucose), measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the first two-weeks of the study.
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 first two-weeks of the study.
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. Most recent HbA1c 5.7-6.4% (39-47 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. Recorded diagnosis of diabetes.
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
Hathaway Medical Centre
SN14 6GT
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
The Adam Practice
BH15 4JQ
United Kingdom
Trial participating centre
Atherstone Surgery
CV9 1EU
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
To be made available at a later date
Basic results (scientific)
Publication list