50 - EFFICACY AND SAFETY OF THE PATIENT EMPOWERMENT THROUGH PREDICTIVE PERSONALISED DECISION SUPPORT (PEPPER) SYSTEM: AN OPEN-LABEL RANDOMISED CONTROLLED TRIAL
Abstract
Background and Aims
The Patient Empowerment through Predictive Personalised Decision Support (PEPPER) system provides personalised insulin bolus advice for people with Type 1 diabetes (T1D) by means of an artificial intelligence-enhanced bolus calculator based on case-based reasoning. The system also incorporates a safety layer which includes predictive glucose alarms, low-glucose suspend for insulin pump users, and personalised carbohydrate recommendations. Here, we evaluate the safety, feasibility and usability of the PEPPER system compared to a standard bolus calculator.
Methods
Randomized controlled cross-over study. After a 4-week run-in, participants were randomized to PEPPER/Control or Control/PEPPER in a 1:1 ratio for 12-weeks. Participants then crossed over after a 3-week wash-out period. The primary endpoint is percentage time in range (3.9mmol/L – 10.0mmol/L) between the two groups. Secondary endpoints include percentage times in glycaemic ranges (hypo- and hyperglycaemia), glycaemic variability, HbA1c, quality of life questionnaires and safety system outcomes.
Results
58 participants (on multiple daily injections and insulin pump) were recruited at two clinical sites; Imperial College London in the UK and the Institut d'Investigació Biomèdica de Girona in Spain. Participants were (median(interquartile range)) aged 40.5 (30.8-50.3) years, with a diabetes duration of 21.0(11.5-26.3) years and HbA1c 61(59-66) mmol/mol. 51% used an insulin pump. Study completion is anticipated in November 2019 with a complete dataset of primary and secondary outcomes available for presentation in February 2020.
Conclusions
The results of this randomized controlled trial will help establish whether an adaptive bolus calculator with integrated safety system benefits individuals with T1D more than standard bolus advisors.
