Singapore General Hospital (SGH) works with a medical technology company that makes digital solutions for kidney care for patients and carers to start a pre-pivotal clinical trial with the enrollment of their first subject to study the safety and effectiveness of an improved Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) device.
The US Food and Drug Administration (FDA) has given ‘Breakthrough Device Designation’ to the AWAK PD system, which is a wearable and ultra-portable peritoneal dialysis (PD) system that helps people with end-stage kidney disease to get dialysis on the go.
The prospective, single-arm, single-site study is a follow-up to the first-in-human study, which found no major side effects. Researchers from SGH are now looking for people to take part in this pre-key clinical study.
With the improved version of the device, going into the pre-pivotal trial is a big step towards changing the dialysis business. The first-in-human study gave important information and feedback that helped improve and change the product.
“Although most patients with end-stage kidney disease are on haemodialysis, peritoneal dialysis offers similar efficiency and cost-effectiveness with the added flexibility of treatment schedule to accommodate one’s lifestyle and offers patients another option to choose from,” said Associate Professor Marjorie Foo, Principal Investigator of both AWAK PD trials and Senior Consultant, Department of Renal Medicine, SGH.
Despite the fact that COVID-19 development has slowed, they have continued to improve the device and are now ready to start on a pre-pivotal study, bringing them one step closer to what patients hope for and anticipate a life on dialysis that will have minimum impact on their lifestyle while providing high-quality dialysis.
Digital technology has generated substantial advances in a variety of industries, including dialysis. The incorporation of digital technology in dialysis has resulted in various advantages, including improved patient care, treatment efficiency, and overall outcomes.
Remote monitoring of dialysis patients is possible thanks to digital solutions. Healthcare practitioners can track vital signs such as blood pressure, heart rate, and hydration levels in real-time using wearable devices and connected health platforms. This enables proactive interventions and timely treatment plan revisions, lowering the likelihood of problems and hospitalisations.
Through the application of predictive analytics and machine learning algorithms, digital technology aids in the optimisation of dialysis treatments. These technologies can help uncover trends and patterns in patient data, such as laboratory findings and treatment responses, to advise treatment changes for optimal outcomes.
To allow patients to take an active role in their dialysis care, digital platforms provide instructional resources and self-management applications. Diet and fluid limits, medication reminders, and lifestyle suggestions are all available through mobile apps and Internet platforms. This assists patients in adhering to treatment plans, improving their understanding of their illness, and making educated health decisions.
SGH is at the forefront of experimenting with digital technologies to improve patient care. SGH intends to improve patient accessibility and comfort by implementing technology such as telemedicine and remote monitoring.
They are working on mobile apps and digital platforms that will allow patients to access medical records, make appointments, and receive personalised health information. SGH is also utilising artificial intelligence and machine learning to improve diagnoses and treatment plans.
These digital initiatives not only streamline healthcare processes but also empower individuals to take an active role in their own health management. SGH’s digital innovation commitment is transforming healthcare delivery and increasing patient outcomes.