Background
One of the most critical reasons that therapies fail is because of non-adherence. It is crucial that data on adherence in clinical trials is robust as poor adherence may affect study outcome. Elucid designed the Pill Connect system to address this. Pill Connect is a smart medicine bottle, companion mobile application and remote monitoring system. The primary objectives of this study: acceptability and usability collected via questionnaires. The secondary objectives: subject adherence and bottle robustness. 
Methods
A pilot study on a dose escalation/de-escalation trial in healthy subjects within a research unit and at home. 10 subjects tested this system between 5/3/19 and 18/3/19, with a dose schedule of 2 daily dispenses. This included a trial stop for some of the subjects. Data collected pre-study included mobile phone device (iOS or android). Each subject received 2 smart medicine bottles, 26 capsules in one and 32 capsules in the other. Two focus groups were held, pre-trial and post-completion. 
Results
100% of subjects agreed that the system was easy use. Pharmacy agreed that the assembly was easy. The system successfully dispensed 88% of all doses and this was correctly uploaded to the server. The adherence rate was at 96%, and this was defined by subjects attempting to dispense at the correct times. The lock out period was a 100% success.
Conclusion
Preliminary data was positive and advocates that public acceptance is likely and certainly could aid adherence. The results demonstrate this system could prevent patients from double dosing. Future studies should be done on a larger sample size, multiple drugs and with actual patients to collect rigorous data. An intended outcome of using adherence monitoring technology is to improve the data used to model adherence in PK/PD analysis. When these models are assumed, potentially on 100% adherence, variance due to episodes of non-adherence may be eliminated.

Pilot study on remote adherence monitoring using novel digital packaging

DIA Europe 2020 

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