Plain English Summary
Background and study aims
Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or that the body’s cells don’t react to insulin as they should do (insulin resistance). Prediabetes is a condition where a person’s blood sugar levels are higher than normal, but nor high enough to be classified as T2DM. If left untreated, then prediabetes can turn into T2DM. It is estimated that 11% of the population have prediabetes. Type 2 diabetes costs the NHS £23.7 billion every year and there are an estimated 174.8 million individuals are living with undiagnosed Type 2 diabetes globally. Therefore, early treatment to prevent the onset of Type 2 diabetes is needed. Lack of regular physical activity has been shown to directly cause 7% of Type 2 diabetes cases worldwide and is an established risk factor to developing the disease. However current efforts to increase population physical activity levels have been unsuccessful. Providing individuals at risk of developing Type 2 diabetes with feedback on both their physical activity as well as the immediate consequence of that behaviour on their health (blood sugar levels) could be a good solution. The aim of this study is to test this strategy to find out if people engage with the technology to see the feedback, and whether they believe it helps motivate them to be more physically active, in order to see if a full scale study would be possible.
Who can participate?
Adults aged 40 years or older with a moderate or high risk of developing T2DM who own an Android smartphone
What does the study involve?
Participants are randomly allocated to one of three groups. At the start of the study, participants in all groups undergo a range of measurements to assess their body composition, fitness and background information. Those in the first group receive feedback about their blood sugar levels for four weeks. Those in the second group receive feedback about their physical activity levels for four weeks. Those in the third group receive feedback about their blood sugar levels and physical activity levels for four weeks. After the programme, participants are asked to take part in an interview about their experience using the technology and to complete questionnaires. Participants also wear a special device which repeatedly measures their blood sugar levels to measure the change over a period of time.
What are the possible benefits and risks of participating?
Participants may benefit from improved health in terms of blood sugar control and increased physical activity. No risks are foreseen but participants may experience skin irritation or slight discomfort when wearing the blood glucose monitor.
Where is the study run from?
National Centre for Sport and Exercise Medicine, Loughborough University (UK)
When is the study starting and how long is it expected to run for?
January 2017 to December 2017
Who is funding the study?
1. The Movement Insights Lab (UK)
2. Loughborough University (UK)
Who is the main contact?
Miss Maxine Whelan
m.e.whelan@lboro.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Miss Maxine Whelan
ORCID ID
http://orcid.org/0000-0002-9203-3162
Contact details
National Centre for Sport and Exercise Medicine
School of Sport
Exercise and Health Sciences
Loughborough University
Epinal Way
Loughborough
LE11 3TU
United Kingdom
+44 7435 330992
m.e.whelan@lboro.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R17-P049
Study information
Scientific title
The Sensing Interstitial Glucose to Nudge Active Lifestyles (SIGNAL) Study: Combining novel self-monitoring technologies for persuasive behaviour change in people at moderate or high risk of developing Type 2 diabetes
Acronym
SIGNAL
Study hypothesis
1. Providing individuals with both behavioural and physiological feedback will encourage greater engagement with the self-monitoring technology than providing individuals with only one feedback component
2. The level of user engagement with the self-monitoring technology will be related to the extent to which individuals increase their physical activity
Ethics approval
Loughborough University Ethics Advisory Committee, 21/04/2017, ref: R17-P049
Study design
Interventional three arm randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
The participant information sheet is available at http://www.lboro.ac.uk/research/mi-lab/research/signal/
Condition
Prediabetes
Intervention
Following enrolment, participants’ baseline physical activity will be measured for one week using two devices, an ActiGraph GT3x-BT and a Fitbit Charge 2. No feedback will be provided during free-living wear. Following completion of baseline, participants will be block randomised to one of three groups (1:1:1).
Group 1: Participants will receive a flash glucose monitor (Freestyle Libre; providing feedback) and a physical activity monitor (Fitbit; not providing feedback) for four weeks.
Group 2: Participants will receive a Freestyle Libre (not providing feedback) and Fitbit (providing feedback) for four weeks. Following this, participants in groups 1 and 2 will have access to feedback from both devices for the remaining two weeks of the intervention.
Group 3: Participants will receive a Freestyle Libre (providing feedback) and Fitbit (providing feedback) for the full six weeks of the intervention.
The study design will allow comparisons between groups having access to feedback from only one device (Groups 1 and 2 during initial four weeks) and feedback from two devices (Groups 1 and 2 during final two weeks and Group 3 during the full six weeks). It will also allow for the quantification of any decay in device engagement over time.
Following the intervention, participants will complete a semi-structured qualitative interview (20-40 minutes) to discuss their experience using the technology and receiving feedback about physical activity and/or glucose levels. Interviews will be audio-recorded with permission and transcribed verbatim.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Device engagement will be assessed by:
1. Time spent on the official LibreLink application using Ethica Data at 1, 2, 3, 4, 5, and 6 weeks
2. Time spent on the official Fitbit application using Ethica Data at 1, 2, 3, 4, 5, and 6 weeks
3. The number of Freestyle Libre scans using LibreLinkUp application at 1, 2, 3, 4, 5, and 6 weeks
4. The number of user-driven Fitbit syncs using Fitabase at 1, 2, 3, 4, 5, and 6 weeks
5. Semi-structured interviews at 6 weeks
Secondary outcome measures
1. Feasibility of delivering the intervention is measured using semi-structured interviews, researcher notes, Ethica Data, Fitabase, Diasend, LibreLinkUp at 1, 2, 3, 4, 5, and 6 weeks
2. Physical activity is measured using Fitbit Charge 2 at baseline and 1, 2, 3, 4, 5, and 6 weeks
3. Interstitial glucose levels are measured using Freestyle Libre at 1, 2, 3, 4, 5, and 6 weeks
4. Eligibility, uptake and retention is measured using researcher notes at baseline, 1, 2, 3, 4, 5, and 6 weeks
5. Changes in technology readiness is measured using the Technology Readiness Index 2.0 at baseline and 6 weeks
6. Health literacy is measured using the eHealth Literacy Scale at baseline and 6 weeks
7. Health status is measured using the 5Q-5D-5L at baseline and 6 weeks
8. Attitude about health is measured using the Risk Perception Survey – Developing Diabetes at baseline and 6 weeks
Overall trial start date
02/01/2017
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. At least 40 years of age
2. Own a compatible Android smartphone [Version 4.3+ with access to internet, Bluetooth and near infrared communication (NFC))]
3. Have a moderate or high risk of developing Type 2 diabetes (score ≥16 points on a validated Type 2 diabetes screening survey)
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
Aim to recruit 45 individuals (15 in each group).
Participant exclusion criteria
1. Have a clinical diagnosis of Type 1 or Type 2 diabetes or a HbA1c reading of >6.4%
2. Unable/unwilling to provide informed consent
3. Unable/unwilling to adhere to the study protocol
4. Unable to understand written/verbal English
5. Pregnant (suspected or confirmed)
Recruitment start date
18/05/2017
Recruitment end date
30/11/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
National Centre for Sport and Exercise Medicine
School of Sport, Exercise and Health Science
Loughborough University
Loughborough
LE11 3TU
United Kingdom
Sponsor information
Organisation
Loughborough University
Sponsor details
Epinal Way
Loughborough
LE11 3TU
United Kingdom
+44 1509 222222
Enquiries@lboro.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The Movement Insights Lab (MI-Lab)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Loughborough University
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The protocol of the study will be published in a scientific journal. The study results will be published in a scientific journal and disseminated at local, national and international conferences in the form of academic abstracts, posters and oral presentations. It will also be publicised via the National Centre for Sport and Exercise Medicine media channels (e.g. website and social media). Study results will also be fed back to participants.
IPD Sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from m.e.whelan@lboro.ac.uk
Intention to publish date
31/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list