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Consideration for Device Selection in Clinical Trials

W E LCO M E TO T H E D E LV E B LO G .

FPO

Considering a wearable for an upcoming study?

Below are items we often discuss with clients when selecting a device for their study:

  • Study objectives (therapeutic area, the concept of interest, endpoint required, duration of the study, blinded/unblinded data, etc.)
  • Patient centricity (ease of use, passive monitoring or active assessment, reduce the patient burden and support – patient concierge)
  • Device characteristics (scientific evidence and validations, battery life, connectivity)
  • Data (transfer, storage, analytics)
  • Regulatory considerations
  • Privacy and security

How else can Delve Health help you?

1. Connected digital scales

Bring your digital scales and be able to connect to Clinical StudyPal for real-time measurement. With connected scales it is possible to perform on site monitoring of weight remotely.

2. Fitbits, Apple Watches & medical watches

Whether you are looking to use Fitbit, Apple Watch or Google, we can track activity, heart rate,  sleep, ECG, and much more. Real-time data capture all the above measurements. These devices help measure performance continuously when patients are away from the clinical sites, resulting in reliable study outcomes.

3. mHealth devices

Using mobile phones, patient acquire data through our Clinical StudyPal app, where patients can record pain, bowel diary, quality of life questionnaire and more.

4. Wearable glucometers

Remotely monitor patients’ blood glucose levels between appointments and site visits. Individual targets can be set for patients, and an automated alert system will let study teams know when deviations occur. Results are available through Clinical StudyPal and real-time Analytics

5. Connected blood pressure meter

A blood pressure meter is one of the most traditional clinical study equipment. For clinical trials we have selected a high-end medical device that measures blood pressure remotely with clinical accuracy around the wrist. All physical and sleep activities are measured at home, which enables continuous monitoring at night.

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