How SMART™ Works
The SMART system consists of a tagged medication that is detected with a hand-held breath analyzer, with data storage and reporting capabilities.
The first generation SMART system includes a monitor designed for use on a countertop in the home. The monitor functions both as a medication reminder and a detection/recording device. At the clinical trial site the monitor is pre-programmed for the time of day the medication is to be taken. The device is then given to clinical trial enrollees when they initially visit the clinical trial site and receive their trial medication. Participants receive a brief training at that time on how to use the device, and they take the device home with them.
Operation is a study in simplicity:
- The device signals a reminder to let the patient know it is time to take the medication;
- With graphic display prompts along the way, the patient takes the medication and presses a button on the device;
- The device records a count-down of a few minutes, giving the medication time to dissolve in the GI tract and for the taggant to be metabolized and appear in the blood and breath;
- Again with graphic display prompts telling what steps to take, the patient blows into a breath collection tube and places the tube into a portal on the front of the device;
- The device detects the taggants in the breath sample in the tube and provides an on-screen "OK"
The system records the date and time the medication was taken, and that data is available for the pharmaceutical company or company conducting the clinical trial. Because there is no way for the taggant metabolites to be detected in the breath without the drug having been ingested and metabolized in the GI tract, the data generated from a SMART drug trial is as reliably definitive as if the enrollees had been physically observed taking each dose of their medication.
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