Efficacy and safety of the Patient Empowerment through Predictive Personalised Decision Support (PEPPER) system: an open-label randomised controlled trial

Background: 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.