Just switch on

It really is that simple for your subjects. The iModem will power up, locate a mobile network and connect to the server. All fully automatic.
But that is only where it starts.


Measure


The first thing is that a subject takes readings. NetMedical has selected clinically validated devices based on a.o. their ease of use, making self measuring easy to do.

Collect


With BluetoothTM equipment, the iModem automatically collects measurements. With wires devices the only thing that a subject would do is regularly connect the medical device with the iModem and readings are collected.

Transmit


The iModem determines when to send readings. Typically, this would be once a day, or when more than 'x' measurements are in memory. But this is configurable to match the study protocol.

Manage & Alert


Once the measurements are received by the Clinical Trial website, alert levels are determined and alerts are sent to either CRA or investigator.

What the iModem supports

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 Blood pressure readings
Weight readings
Glucose readings

See the iModem equipment overview for the specific devices the iModem system supports.


Need us to think with you?

Let us know whether you think the iModem system may be of help, but you like us to think with you on how the advantages translate into your study.

Contact our sales team to discuss your study protocol or wishes, and we will help you decide on whether this is something that would fit.

Contact NetMedical sales team at sales@netmedical.nl.

A typical clinical trial scenario

Although each protocol is different, let us take an example clinical study and follow hoe the iModem system can help it forward on multiple levels.


Say your study protocol defines a 2 week washout period, in which you need patients to reach certain blood pressure levels for subject exclusion/inclusion. The steps would be:

  1. The subject enters the clinic on Visit 1 and received the instruction on the iModem and blood pressure equipment. After doing a verification/start reading the subject is sent home for two weeks.
  2. The subject comes home and plugs the iModem in the power socket. Following protocol, the subject for instance takes two readings in the morning and two in the evening.
  3. The iModem automatically collects these readings and sends them through to the Clinical Trial website, for instance early next morning.
  4. The Clinical Trial website compares the readings for this subject against the inclusion/exclusion criteria. When threshold levels are reached, the website sends an alert to (most likely) the investigator. Upon entering the clinic, the investigator reads his/her e-mails and can respond to it by calling the subject to check about this reading or maybe directly invite the subject back into the clinic.
  5. If the subject has no out-of-range values, still the investigator on Visit 2 will check the blood pressure to see whether the subject still can be included

This small example shows that the iModem system in this case helps to increase the enrollment speed and at the same time improve on patient safety monitoring in such wash out phase.

In addition, you will have much better baseline readings for the subjects.




Designing your protocol for telemedicine

When this all sounds great, the next step is designing your protocol for using iModem telemedicine. There are a number of things to think about when doing that.

Choose the goals

The iModem system can be used in a variety of applications in your trial, from patient safety to subject enrollment strategy. There are many ways to let the iModem system work for you. To help you define, contact our commercial account managers and they can help you answer the questions.

Define the protocol

Writing telemedicine in your protocol is not a straighforward task, but it isn't very hard either. You do, as with so many other parts in a protocol, have to define the criteria and output for the telemedicine system. Again, this is not new for NetMedical and our project managers can help you write your protocol to include the advantages.

Choose the equipment

Next to blood presure, glucometer and scales, you can also choose betwee different flavours of iModems (see iModem overview ). Which model you'd need is based on the countries for your study, the anticipated travel distance of subjects and other deployment specifics. NetMedical has extensive experience in over 40 countries for deploying iModems.

Choose the outsourcing partner (if any)

NetMedical has a few partners that already have extensive experience in applying the iModem in global clinical trials. It may be fruitful for you to choose a NetMedical CRO partner that knows the ropes, so to say. NetMedical of course will work with your preferred outsourcing partner.

Contact our commercial account managers to get a feel for what your study would require.