Proteus Digital Health yesterday presented interim results from a study of its Proteus Discover for patients with uncontrolled hypertension and type 2 diabetes, claiming use of the system raised patient compliance, lowered blood pressure and reduced low-density lipoprotein-cholesterol.
The Chicago-based company’s Proteus Discover operates through the use of an ingestible sensor, the size of a grain of sand, which is activated when it reaches the stomach and communicates with a wearable sensor patch which records time of ingestion and personalized data such as heart rate, physical activity and rest. The data can be seen by a patient through a mobile app, which can be shared with healthcare professionals to optimize patient treatment.
“The promising results from the pilot study demonstrate that this innovative digital approach to therapy optimization is not only patient-centered, but can lead to improved clinical outcomes. The findings suggest that deploying a panel of medicines that reflect the needs of patients and physicians can move the needle in treatment optimization,” chief medical officer George Savage said in prepared remarks.
The12-week, 96 patient study enrolled patients with uncontrolled hypertension and type 2 diabetes who failed at least 2 anti-hypertensive medications plus metformin and/or sulfonylurea. Patients in the trial received treatment with the Proteus Discover for 4 to 12 weeks or usual care based on a cluster randomized study design, the company said.
Primary outcome for the study was a change in systolic blood pressure at week 4, with secondary outcomes including change in diastolic blood pressure and proportion of subjects at the BP target.
Data from the study indicated that 85% of patients treated with Proteus Deliver achieved target blood pressure at 4 weeks, while only 33% of patients receiving usual care hit their targets. Proteus Discover users also reported greater reduction in SBPs than usual care and a greater reduction in DBP and LDL.
The results of the study are slated to be published later this year, Proteus said. The company is also partnering with customers to “generate real-world clinical and economic evidence” of their Proteus Discover.
The company said the new study builds upon evidence from 66 previous studies across diverse patient populations assessing the accuracy, safety and feasibility of the device in patients with hypertension and diabetes.