Proteus Digital Health previously received FDA approval for use of its ingestible pill sensor in schizophrenia in collaboration with Otsuka Pharmaceutical and has also incorporated the sensor into chemotherapy pills. (Pixabay)
A study of Proteus Digital Health’s ingestible pill sensor found it performed better than directly monitoring drug adherence among patients with tuberculosis taking monthslong maintenance therapies.
Adherence to TB treatments is essential, not only to cure the disease but also to prevent the development of drug-resistant strains. Typical antibiotic regimens include an intensive treatment phase of about two months followed by a continuation phase spanning four to seven months, according to the Centers for Disease Control and Prevention.
The former Fierce 15 winner’s digital pill consists of a biodegradable sensor about the size of a grain of sand that generates an electrical signal as it dissolves in the stomach. This signal is picked up by a skin patch that relays the data to a mobile phone.
Proteus previously received approval for its use in schizophrenia in collaboration with Otsuka Pharmaceutical and has also incorporated the sensor into chemotherapy pills. The company’s system also allows for extra physician support for those that miss doses.
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The study, published in PLOS One, followed TB patients in clinics in southern California and at home to confirm adherence to a daily series of therapies over the continuation phase. Among those being followed by Proteus’ digital tracking, if a regular ingestion was not detected, the person was contacted within 24 hours by text or by phone to provide reminders.
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Proteus’ sensor was 99.3% accurate in correctly detecting ingestions and demonstrated daily adherence rates of 93% when randomized against having a clinician directly observe the swallowing of the pill, which had a 63% rate. This was mainly due to the sensor’s ability to work seven days a week, compared to the days when a clinic may be closed or understaffed.
Additionally, 100% of participants reported that they preferred the wireless observation method, according to the researchers, who said the system should be tested in high-burden TB settings where it may support adherence among programs in low- and middle-income countries.
