eSense™ Measurement Devices

PHT eSense medical devices integrate with the PHT eCOA System to collect and evaluate physiological patient measurements and PROs for Diabetes and Respiratory clinical research.

eSense Integrations Accelerate Subject Enrollment -Instead of conducting two separate manual functions with each subject – eligibility measurements and diary enrollment – site personnel can rapidly capture patient readings and assign that eSense device to a diary for subsequent electronic and undisputable data integrity.

Cumulative eSense Data with ePRO Reduce Sample Sizing – Biostatisticians and clinicians have a more holistic view of each subject, with both objective eSense readings and subjective ePROs. Since data are electronic and available on the PHT StudyWorks web portal, analyses are rapid and constant.

PHT eSense Enables Adaptive Trial Design – Subjective and objective data collection integrations enable trial managers and statisticians to conduct adaptive trials with fewer subjects, and shorter timelines.

Improving trial design from sequential to continuous monitoring of trial data allows for a wide range of other parameters to be changed.

Patients use PHT eSense devices to measure their personal PEF or glucose levels. In addition to providing subjects with instant feedback on their current condition, device measurements are directly transferred via wireless sensor technology to each patient diary which stores each reading and compares it to previous measurements:

For Diabetes Clinical Trials – PHT eSense glucometers enable mobile testing, monitoring and screening of blood sugar for patient within trials testing different drug mechanisms for the indication of diabetes. Since diabetic patients are committed to frequent blood sugar monitoring, compliance is generally high.

The PHT eSense glucometers are used by patients older than five. Measurements are used to adjust insulin doses, medications, meal planning, and exercise to greatly improve blood sugar levels.

For Respiratory Trials – PHT eSense respiratory monitors enable mobile monitoring and screening of patients with chronic respiratory diseases, including asthma, cystic fibrosis, COPD and transplant patients. Each device measures airflow out of the lungs when blown into as hard and fast as possible, and can reveal narrowing of the airways well in advance of an asthma attack being felt by the asthmatic. The PHT eSense PEF meters are used by subjects over the age of five to monitor their respiratory treatment.

For diabetes and respiratory trials, PHT eSense glucose measurements rapidly determine:

• Which patients qualify for a trial
• When patients should contact their site due to symptoms
• Whether to modify the management and treatment plan

Together with their personal diary data, eSense measurements are transmitted to the PHT StudyWorks web portal where clinical trial leaders and investigators can view cumulative real-time, time-stamped data.

Integration of eSense medical devices with the PHT ePRO System provides greater value than the merely capturing PEF, Forced Expiratory Volume (FEV1), Forced Expiratory Flow rate (FEF) and Glucose measurements with ePRO data.

As smart devices, PHT diaries do more than simply collect and transmit eSense measurements. Each PHT ePRO device can be designed to

• Compare current data with historical eSense data to trigger safety alert;
• Execute calculations locally, without requiring transmission, for immediate safety messaging; and
• Trigger additional condition-specific questions formerly unavailable with separate and manual measurements.