Tag Archives: remote monitoring

Start using electronic data capture in clinical trials

A recent publication suggests that Electronic Data Capture systems, or EDCs, should be implemented in clinical trials. The EDC software can reduce the overall trial costs by an estimated $347,600 in a phase ll trial of 20 sites, 10 patients per site and a duration of 12 months plus data cleaning. See the table.

Forrester-Research-Paper-versus-EDC-cost-comparison1

Table: Forrester Research Paper versus EDC cost comparison.

In this example, monitor visits still costs $ 180,000. Vitaphone CTS provides solutions to make subjects monitor their vital signs at home. This can also enhance their trial compliance. Re-activity is a top priority to create better and more efficient clinical trials. The tools developed by Vitaphone CTS will send biosensor data immediately and thus ensure almost real-time data. Our medication adherence support system (MASS) stimulates the study subjects to take their study medication.

Remote monitoring and support enables pharmaceutical, biotechnology and medical device industries to focus on the development of the best drug or device.

Using telemonitoring solutions, investigators can improve patient safety. This might be achieved through faster notification of adverse events to the Principal Investigator, CRO or Sponsor. This will support earlier and better decision-making. Embrace technology.

Author: Indy Kavelaars

Source: Clinovo

 

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Remote monitoring is on the rise

Worldwide, 3 million patients have a remote monitoring device at home that is monitored by a professional caregiver. This states a new report by Berg Insight. IF this market will grow is not a question, but HOW this market will evolve that is the important question. Berg Insight sketches a future for connected medical devices with a compound annual growth rate (CARG) of 44.4 percent. It is estimated to reach €19.1 million connections by 2018.

remote-monitoring-device-market-by-Berg-Insight

Patients that use connected medical devices for various forms of personal health tracking are not included in this figure.

 

 

 

 

 

They claim revenues of remote patient monitoring has reached €4.3 billion in 2013. Between 2013 and 2018 they expect revenues will grow with 35 percent, reaching €19.4 billion. What kind of monitoring is now booming in this market?

  • Cardiac rhythm management; accounts for two-thirds or 2 million connections and will grow to 4 million by 2018
  • Sleep therapy; represents about 0.54 million people
  • Telehealth, medication adherence and airflow monitoring have 0.34 million connections. Interesting fact is that pharmaceutical companies will move into this space as well.

Vitaphone expects Berg Insight to be be right: this market will grow. We are definitely going to help to develop a better and more efficient healthcare by introducing cutting edge solutions in remote monitoring of vital signs.

Author: Indy Kavelaars

Source: Berg Insight

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From Holter to event monitoring!

An article of the NIH, National Institutes of Health, states that a dramatic leap in mHealth will take place when we have small, inexpensive wireless devices with sensors that monitor our physiology.[1] This means our heart rate, blood pressure, blood sodium and glucose levels, breathing patterns, brain waves and so on. These can then be transmitted to the physician, who can in his turn take actions that may spare you a trip to the hospital or even save your life.

In a clinical trial, a wireless adhesive patch was tested next to the traditional technology (the Holter) to measure heart activity. With the traditional technology, the Holter must be worn for 24 hours; it records the full 24 hours. Getting a good reading is particularly challenging when the arrhythmias occur episodically. The adhesive patch can be carried around for a longer time, like a week. The patch had 15% less use-able readings in the first 24 hours but people were asked to wear it until they could tolerate it. The subjects wore the adhesive patch for 11 days on average. Because people wore the patch longer, there were significantly more (96) use-able readings than with the Holter (61).[2] Nice data that demonstrates cardiac event monitoring works.

The cardiac event recorders, developed by Vitaphone, send the registered events within seconds to the physician or the events are firstly analyzed in the telemonitoring Service Centre and then sent through. Many event recorders are in use by Dutch hospitals. Have a look at the users list >

Cardiac event recording is available and can function as replacement for the Holter monitoring!

Author: Indy Kavelaars @ Vitaphone Netherlands

Source: [1] NIH Directorsblog

[2] Comparison of 24-hour Holter Monitoring with 14-day Novel Adhesive Patch Electrocardiographic Monitoring. Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, Fought AJ, Topol EJ. Am J Med. 2014 Jan;127(1):95.e11-7.

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Survey results: Remote monitoring of cardiac implantable electronic devices

The European society of cardiology recently published the results of their survey on remote monitoring of cardiac implantable electronic devices (CIEDs). The aim of the survey was to get insight into the current use of remote monitoring (RM) of CIEDs in Europe. Responses were received from 54 centres belonging to the European Heart Rhythm Association (EHRA) electrophysiological (EP) research network.

Some interesting results: a total of 76.5% of the centres reported that they are actively using remote monitoring. RM is most used for implantable cardioverter-defibrillators and rarely or never used for routine pacemaker checkups, because the latter seems to be less cost-effective.
In 29,8% of the European centres, the delay between detection of an abnormality by RM systems and the physician’s response is within 24h.
The face-to-face 6-month check-up visits are drastically reduced by RM. Only 17.6% of all centers perform internet check-ups at predefined intervals.

Some areas for improvement.
In only 6.4% of the cases information obtained by RM is incorporated into the clinical patient file! Why is that?
Also in 25% of the centres, there is no specific workflow designed for RM. Only with a clear workflow follow-up and registration of the findings is possible.
Almost 40% of the patients reported to prefer RM as their main follow-up management, because it helps to avoid unnecessary visits to the hospital.

We believe RM will become more and more accustomed! For the 23.5% of the centres that not use RM; let’s make it happen!

Author: Indy Kavelaars @ Vitaphone Netherlands

Source: Europace Oxfordjournals

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