In Vitro Medical Device Clinical Study.
Research type
Research Study
Full title
User Performance and System Accuracy Evaluations using Glucose Adjustment.
IRAS ID
169617
Contact name
Laura Ritchie
Contact email
Sponsor organisation
LifeScan Scotland Ltd, a J&J Company
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 5 days
Research summary
This is an open-label, non-randomised pilot study, to evaluate user performance and system accuracy.
Twelve male and female volunteers aged 18-45, with a documented diagnosis of Type I diabetes for at least 12 months and treated with a basal bolus insulin regime will be enrolled in this study.
Eligible volunteers will check in to the study unit on the evening of Day -1 and will participate in an in vivo glucose adjustment procedure on Day 1 in which their blood glucose will be adjusted and maintained within a specified range of 63-75mg/dl (3.5-4.2mmol/l). In vivo glucose adjustment will be achieved by means of a modified hyperinsulinemic glucose clamp technique.
Once blood glucose is confirmed to be within the target range and following current ISO guidelines user performance and system accuracy assessments will be performed using approved CE marked Lifescan Blood Glucose Monitoring Systems (BGMSs [Verio and Delta technology]).
Volunteers will be monitored for up to 4 to 6 hours following the in vivo glucose adjustment procedure, after which a post-study medical will be performed and they will be discharged from the study unit.
The study duration for individual volunteers will be up to approximately 24 hours. This is the duration from check-in to the study unit on Day -1 until the post-study medical.
REC name
HSC REC B
REC reference
15/NI/0006
Date of REC Opinion
22 Jan 2015
REC opinion
Favourable Opinion