SMARTSHAPE
For Patients
High blood pressure (hypertension) silently claims around 9 million deaths globally each year. People living with hypertension require lifelong vigilance of their blood pressure levels to prevent serious health problems like stroke or a heart attack. How does SMARTSHAPE compare to current blood pressure monitoring?
Blood pressure monitoring
Why the SMARTSHAPE sensor?
When comparing SMARTSHAPE to existing blood pressure monitoring systems, how will SMARTSHAPE do better?
Periodic measurements
The most common method for monitoring blood pressure is by using a cuff that takes periodic measurements. However, this approach fails to give the full picture of the patient’s condition, as it only offers periodic snapshots that can miss important fluctuations that may happen during the day. Knowing these fluctuations is key to finding the best treatment plan for each patient. The wearing of a cuff based blood pressure monitor can be disruptive and uncomfortable for the patient, due to the occlusive nature of the inflating cuff. This in itself may influence the patient’s blood pressure throughout the monitoring period.
Current continuous measurements
Continuous blood pressure monitoring offers a more efficient way to manage hypertension and can better inform individual medical treatments. However, current existing methods for continuous blood pressure measurement are either too invasive – such as inserting a catheter on a patient’s artery in hospital settings –
or lack clinical accuracy, which is the case for many wearable devices like watches. Other existing technologies that allow for direct blood pressure measurement are unsuitable for long-term use; leaving patients with few practical and accessible options to manage their condition.
SMARTSHAPE: Continuous monitoring, personalised control
The need for a continuous and non-occlusive blood pressure monitoring method that is both practical, clinically accurate and suitable for long-term use, has brough the SMARTSHAPE consortium together to develop a better solution.
When comparing SMARTSHAPE to existing blood pressure monitoring systems, how will SMARTSHAPE do better?
Periodic measurements
The most common method for monitoring blood pressure is by using a cuff that takes periodic measurements. However, this approach fails to give the full picture of the patient’s condition, as it only offers periodic snapshots that can miss important fluctuations that may happen during the day. Knowing these fluctuations is key to finding the best treatment plan for each patient. The wearing of a cuff based blood pressure monitor can be disruptive and uncomfortable for the patient, due to the occlusive nature of the inflating cuff. This in itself may influence the patient’s blood pressure throughout the monitoring period.
Current continuous measurements
Continuous blood pressure monitoring offers a more efficient way to manage hypertension and can better inform individual medical treatments. However, current existing methods for continuous blood pressure measurement are either too invasive – such as inserting a catheter on a patient’s artery in hospital settings –
or lack clinical accuracy, which is the case for many wearable devices like watches. Other existing technologies that allow for direct blood pressure measurement are unsuitable for long-term use; leaving patients with few practical and accessible options to manage their condition.
SMARTSHAPE: Continuous monitoring, personalised control
The need for a continuous and non-occlusive blood pressure monitoring method that is both practical, clinically accurate and suitable for long-term use, has brough the SMARTSHAPE consortium together to develop a better solution.
Co-creation
Patient Experience Panel
The patient perspective is crucial to the project. SMARTSHAPE actively collaborates with a Patient Experience Panel, that brings the patients’ voice into the scientific research.
Jenny
"I joined the Patient Experience Panel of SMARTSHAPE, because I have a personal interest in having a continuous non invasive blood pressure monitoring tool for myself and members of my family. After 3 attempts over the last 2 weeks to have 24 hour ambulatory blood pressure monitoring accurately record my readings, I have found this to be disappointing and ineffective. By contrast I find the idea behind SMARTSHAPE to be brilliant, cutting edge, convenient and hopefully something that can help me and my medical team better manage my health. It can be used to create personalised adaptive treatment and drug protocols to better control my blood pressure more effectively taking into account lots of different factors that affect my individual health and changes from low to high blood pressure, bradycardia and tachycardia as well as finer nuances of changes in arterial blood pressure and blood volume."
Dina
"I have been an advocate for Women's Heart Health since my stroke on 1.2.04. I will be celebrating 20 years as a Stroke Survivor and Women's Heart Health Advocate on 1.02.24! Praise the Lord! High Blood Pressure is the silent killer and I am trying to spread awareness of this fact."
FAQ
Frequently Asked Questions
Do you have any questions about the SMARTSHAPE technology? We’ve listed some frequently asked questions below. If your question is not here, feel free to reach out to us via the Contact page.
Implantation and removal of the sensor
How is the SMARTSHAPE sensor implanted?
The SMARTSHAPE sensor will be very small. Therefore, it will be implanted just under the skin using a needle-based device, without creating any big incisions.
What are the risks of implantation, such as infection?
The SMARTSHAPE sensor is made of biocompatible material and is already being tested for biosafety and biocompatibility, minimising the risks. Even though the risks are minimal, in some cases a potential risk of the implantation is wound infection or delayed wound healing (for example in case someone has other additional conditions which cause wound healing to delay).
To reduce the chances of infection as best possible, all SMARTSHAPE sensors will be sterilised using validated sterilisation methods, and packaged and stored in sterile packaging prior to being inserted using aseptic (microbe free) surgical conditions.
Who will inject the SMARTSHAPE sensor? Can this be done by my GP, or can I self-inject?
The implantation will be performed by GPs or other clinicians.
Will the injection cause a scar?
As the sensor is very small, the delivery of the sensor under the skin through a needle will not cause a lasting scar.
Will the SMARTSHAPE sensor cause any discomfort?
It is not anticipated that the implanted sensor will cause any discomfort.
How long can the device remain under my skin before the sensor material starts to degrade?
The SMARTSHAPE sensor is developed for high risk patients to monitor blood pressure over a period of 6-12 months. The sensor will be able to remain under the skin for this period.
How will the sensor be removed or changed when needed, and by whom?
To remove or change the sensor, a GP or other clinician can make a tiny cut to remove or replace the sensor. As the sensor is located superficially under the skin, it can be reached relatively easy to remove or replace it.
Integration
I already have an Apple watch, a Fitbit, or other health tracker and I don't want to wear another wristband or wearable. Will SMARTSHAPE be able to integrate with these devices?
For now, SMARTSHAPE is working on a dedicated SMARTSHAPE wristband to connect to the SMARTSHAPE sensor. It will be able to connect to an app on your phone via bluetooth. The wristband for SMARTSHAPE will be versatile, similar to existing wearable watches.
I have too many apps already that I use for my health, I don't need another one. Could SMARTSHAPE data be integrated into my existing health apps?
For now, it will link to a dedicated SMARTSHAPE app. Possibly in the future, joint ventures between the SMARTSHAPE app and other existing apps could be explored.
Practical questions
How much will the SMARTSHAPE device cost?
The cost of the SMARTSHAPE device is currently estimated to be between 200-300 USD.
Would it affect travel security or usage of an MRI?
The device will have no effect on travel security and MRI.
Participate in research
How/when can I participate in an experimental trial of SMARTSHAPE?
Currently, SMARTSHAPE is still in the preclinical validation steps, before it is possible to start clinical trials.
At some point in the future, once the technology advances to the clinical trial stage, it may be possible to learn more about getting involved on our website.
Before experimental trials, how can I contribute to this project?
We value the patient’s perspective on the novel device that we are developing. If you are a patient dealing with chronic hypertension, you can contribute to the SMARTSHAPE project by participating in the Patient Experience Panel. Reach out to team@merakoi.com to learn more.
