Efficacy and safety of a medication dose reminder feature in a digital health offering with the use of sensor-enabled medicines.
OBJECTIVE
Over one-half of patients with chronic diseases, such as hypertension and type 2 diabetes (DM), do not take medicines as prescribed. This study assessed the efficacy and safety of "seeing" versus "not seeing" medication dose reminders regarding medication adherence and risk for overdose.


METHODS
Post hoc analysis.


METHODS
Outpatient setting. Adult subjects (18 years of age or older) with uncontrolled hypertension and DM.


METHODS
Subjects enrolled in this institutional review board-approved study were assigned to either use digital health (DH) with the use of sensor-enabled medicines (coencapsulated medicines with an ingestible sensor) for 4 or 12 weeks or receive usual care based on a cluster-randomized design. All subjects were followed for 12 weeks. Subjects using DH were included in the post hoc study consisting of an efficacy analysis and a safety analysis. A main efficacy outcome of comparison of subjects taking medicine with or without "seeing" DH medication dose reminders was assessed. Safety analysis assessed risk of overdosing after DH medication dose reminders.


RESULTS
In 57 subjects included in the efficacy analysis, DH device reminder messages were associated with a 16 ± 16% increase (75 ± 18% when seeing vs. 59 ± 24% when not seeing mobile dose reminders) in medication taking if not taken before dose reminder. The mean overall adherence for all subjects was 86 ± 12%; the mean on-time adherence was 69.7 ± 19.7%. Subjects with lower adherence benefited more from seeing DH reminder messages. In the safety study (n = 74 subjects and 24,426 medication ingestions), no events of overdoses related to DH medication dose reminders occurred.


CONCLUSIONS
This study demonstrates benefits of DH medication dose reminders to improve medication adherence, especially in patients with lower adherence; DH medication dose reminders also appear to be safe.
Penjit
P
Moorhead
Ana
A
Zavala
Yoona
Y
Kim
Naunihal S
NS
Virdi
D000368:Aged; D000553:Ambulatory Care / Q000379:methods; D020811:Biomedical Technology / Q000379:methods; D002908:Chronic Disease; D016000:Cluster Analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D017010:Reminder Systems