Patient Empowerment Through Predictive Personalised Decision Support
Research type
Research Study
Full title
Patient Empowerment Through Predictive Personalised Decision Support (PEPPER)\n
IRAS ID
219566
Contact name
Nick Oliver
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Patient Empowerment through Predictive PERsonalised decision support (PEPPER) is an EU-funded research project to develop a personalised clinical decision support system for Type 1 diabetes mellitus (T1DM) self-management. The tool provides insulin bolus dose advice, tailored to the needs of individuals. The system uses Case-Based Reasoning (CBR), an artificial intelligence methodology that adapts to new situations according to past experience. The PEPPER system also incorporates a safety module that promotes safety by providing glucose alarms, low-glucose insulin suspension, carbohydrate recommendations and fault detection. \n\nThe principal research objectives are to assess the usability, safety, and technical proof of concept and feasibility of the PEPPER in participants with T1DM. Prior to starting the clinical trials a detailed usability study of the PEPPER system will be conducted. Evaluation of safety is a priority and will be assessed throughout the clinical studies. The safety components only of the PEPPER system will initially be evaluated in a 6-week clinical study in an out-of-clinic environment (phase 1) and will measure incidence and percentage time spent in hypoglycaemia, evaluate usability and incidence of technical faults. Following the initial safety study, the overall PEPPER system (integrated with the CBR algorithm) will be assessed over 6 weeks (phase 2) and the primary outcome will be percentage time spent in hypoglycaemia. The final phase (phase 3) will aim to investigate the feasibility and clinical efficacy of the PEPPER system compared to a standard bolus calculator.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
17/LO/0939
Date of REC Opinion
14 Jun 2017
REC opinion
Favourable Opinion