Evaluation of Glucose Monitoring Systems Using In-House Volunteers
Research type
Research Study
Full title
Evaluation of Glucose Monitoring Systems Using In-House Volunteers
IRAS ID
182496
Contact name
Barry Irvine
Contact email
Sponsor organisation
LifeScan Scotland Limited
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
LifeScan is dedicated to best serving the needs of the diabetes community; they develop, manufacture and markets glucose monitoring systems intended for use by people diagnosed with diabetes. These systems enable people with diabetes to check their glucose and manage their diabetes. Studies are currently conducted at the LifeScan Scotland (LFSS) Facility in Inverness, using volunteer employees under REC approval 08/S0801/1, providing blood samples to support internal quality control procedures, testing of glucose systems, research & development and to perform defined studies related to LifeScan and competitor monitoring systems, on a continuous basis.
A recent internal review of this project, with the aim of submitting a new application and providing more clarity of information to Participants was carried out. The Participants’ involvement remains largely unchanged.
The specific testing requirements relating to one or a combination of the following types of assessment will be documented in a separate internal protocol that meets the requirements stipulated in SOP 3020042.
LFSS staff applies samples collected from volunteer subjects to test glucose levels on strips that have been inserted into meters or testing apparatus. Additional samples may also be collected to test on laboratory instruments.
Usability of the system may be assessed by Participants being asked to perform user evaluations of the system in-line with system instructions for use under the supervision of LFSS staff and asked questions relating to the system and ease of use.
Draft Product Labelling (instructions for use/owner’s booklet) may be given to Participants in order to assess comprehension via the completion of a questionnaire.
Participants may take part in a period of home use testing. The main purpose of home use studies will be to evaluate product design, functionality and acceptability in order to develop, modify and improve our products. Some studies may use early versions of a new system and provide feedback, which will allow LifeScan to develop new products.
REC name
North of Scotland Research Ethics Committee 2
REC reference
16/NS/0016
Date of REC Opinion
16 Feb 2016
REC opinion
Favourable Opinion