Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2017
Date assigned
15/05/2017
Last edited
05/06/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

http://www.lboro.ac.uk/research/mi-lab/research/signal/

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 measures

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

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

www.lboro.ac.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/06/2017: The trial record has been updated to reflect that the study will be looking at participants with moderate or high risk of developing Type 2 diabetes, rather than prediabetes.