User Feedback and Usability of Diabetes Care Products
Research type
Research Study
Full title
User Feedback and Human Factors Usability Evaluations of LifeScan Diabetes Care Products
IRAS ID
201817
Contact name
Srikanth Bellary
Contact email
Sponsor organisation
LifeScan Scotland Ltd.
Duration of Study in the UK
5 years, 0 months, days
Research summary
LifeScan Scotland Ltd is a member of the Johnson and Johnson (JnJ) Diabetes Care Companies who design and manufacture products to help people with diabetes to monitor and manage their disease. Products include blood glucose monitoring systems, insulin pumps and diabetes management software, together with instructions for use and packaging. In addition to being safe and effective, products should be innovative, easy to use and meet the needs and expectations of intended users. These studies will evaluate patient feedback and usability of new JnJ diabetes products in order to optimize product design. Products may range from concept through to a prototype device and may include use of simulators accessed on computer/tablet or use of mobile phone Apps. All interactions will be non-invasive and may involve simulated use under realistic scenarios. In 'User Feedback' studies, Participants will be asked to provide insights and feedback via interviews, questionnaires or as part of small focus groups. In 'Human Factors' studies, individual participants will be observed interacting with the product in order to assess usability. The research is funded by LifeScan Scotland Ltd and will take place in the Observation Room, Center for Health Science, NHS Highland. Depending on study requirements, facilities there will allow for research Participants to be observed by JnJ product engineers using a one-way mirror and/or for audio/visual recordings to be made of Participant product interaction and feedback. Recordings can facilitate note taking and capture instances of apparent confusion and allow for review by the wider product development team. Up to N=50 Participants may take part in any individual study, although a more typical sample size would be 7-9. Studies may take approx. 4 weeks to complete. Each Participant would be asked to attend 1-2 sessions, up to one week apart, each session lasting up to 2 hrs.
REC name
North of Scotland Research Ethics Committee 1
REC reference
16/NS/0030
Date of REC Opinion
6 May 2016
REC opinion
Further Information Favourable Opinion