Evaluation of A New Blood Glucose Monitoring Device - HUK 5
Research type
Research Study
Full title
PROTOCOL FOR THE COMMERCIAL STUDY TO ENABLE CE MARKING AND 510(k), FOR THE SALE OF AN ARKRAY BLOOD GLUCOSE MONITORING DEVICE (GLUCOCARD S METERS with GLUCOCARD S Strips) WITHIN THE EUROPEAN UNION AND USA.
IRAS ID
128996
Contact name
Gerrard Rayman
Contact email
Sponsor organisation
AKRAY Factory Ltd
Research summary
This is a commercial study to enable the sale of a new blood glucose monitoring device and manufactured by ARKRAY. A new blood glucose test-strip will be used with a new meter option.\nThe new meter permits the user to mark results to identify if obtained ’before meal’ or ’after meal’, has memory delete function to eliminate abnormal results from memory averaging, has a longer battery life than previous meters and strip eject function to avoid contamination of fingers with blood when removing test strips from the meter.\nThe study will be performed on the currently marketed GLUCOCARD Sigma Meter +strips + new meter + strips.\nWith directly comparable results it will confirm the efficacy of the new meter \nParticipants will be people with diabetes. They will read each manual and instructions and use this information to perform a control solution test and then their own finger−prick, palm-prick and arm-prick blood tests. A professional clinician will then perform the same finger−prick, palm-prick and arm-prick tests on the participant and take a reference blood glucose sample to measure on a laboratory analyser. A maximum of three patient finger−pricks will be used:self−test,reference and professional test samples, two patient palm−pricks and two patient arm-pricks will be used:self−test and professional test samples.\nThe study design relies on participants to be untrained and avoids any demonstration before the self−test is performed.\nIn this way the clarity and conciseness of the new meter’s instructions are evaluated, along with the accuracy of the participant’s self−test results. By comparing the participant’s self−test with that performed by the professional it will be proved that each new meter is suitable for use by both lay people and professionals.\nParticipant volunteers will be recruited from Ipswich Hospital Diabetes Centre and the study is sponsored by ARKRAY Factory Ltd.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
13/WM/0345
Date of REC Opinion
27 Sep 2013
REC opinion
Further Information Favourable Opinion