Clinical Evaluation of an Optical Coherence Tomography BGMS
Research type
Research Study
Full title
Clinical evaluation to compare the system accuracy of an optical coherence tomography blood glucose monitoring system against an industry gold standard glucose analyser via in vivo glucose adjustment by means of a modified hyperinsulinemic glucose clamp.
IRAS ID
197742
Contact name
Don Bogue
Contact email
Sponsor organisation
Compact Imaging Inc.
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
Optical Coherence Tomography (OCT) is a powerful non-invasive medical imaging modality used in clinical diagnostic applications. OCT measures the light-scattering properties of tissue and how those change over time in response to bio-chemical processes and reactions.
This is a clinical evaluation study to compare the accuracy of a new, non-invasive, blood glucose monitoring system which uses multiple reference OCT against an industry gold standard glucose analyser.
Up to 14 Type 1 Diabetics aged 18-60 will be recruited, for a maximum of 10 people to complete study procedures. There will be 2 phases of the study, a pilot and a main phase.
Subjects will undergo a modified hyperinsulinaemic glucose clamp to adjust their glucose levels in vivo over several excursions within the euglycemic and hyperglycaemic ranges. Excursions will consist of several "peaks" and "valleys" of either the same or different amplitudes to ensure a full range of glucose values are evaluated.
The duration of the clamp will depend on the excursions but may last up to 5 hours. Blood glucose will be measured by the investigational product through the skin on the left forearm. The results will be compared with blood samples taken at regular intervals during the excursions and analysed by an industry gold standard analyser.
The glucose clamp will be controlled using a CE marked intravenous continuous blood glucose monitoring probe. As an exploratory objective the results from this system will also be compared to the investigational device.
The pilot phase will consist of 2 subjects who will undergo 2 different excursions. The results of these subjects will be analysed at an interim review to decide on further excursions that will be tested during the main phase of the study with the remaining 8 subjects. The duration of the study for each participant will be no more than 24 hours.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
16/YH/0093
Date of REC Opinion
14 Apr 2016
REC opinion
Further Information Favourable Opinion