New Clinical Trial to Screen Hypertensive Population
DANVILLE, Pa. –Today, the National Kidney Foundation (NKF), Geisinger and Healthy.io announced the launch of a novel clinical trial using a smartphone-enabled home urinalysis device for chronic kidney disease (CKD) among patients with high blood pressure.
Hypertension, or high blood pressure, is a contributing risk factor to CKD. One of the best ways to test for CKD and assess kidney damage is a simple urine test which detects the presence of albumin. The smartphone app from Healthy.io enables lay users to conduct a urinalysis test at home and securely share results with their clinicians.
Approximately 30 million Americans have CKD, but nearly 90 percent do not know they have this condition. CKD progression can be slowed or halted if the disease, which often has no symptoms, is caught in its early stages.
“Early detection of CKD is crucial so that risk factors can be aggressively managed to prevent end-stage renal disease and cardiovascular disease,” said Alexander Chang, M.D., practicing nephrologist and assistant professor in the Kidney Health Research Institute at Geisinger.
“This new trial using a smartphone app and urinalysis kit will provide important information on how to increase testing for CKD in this high-risk population,” said Kerry Willis, Ph.D., Chief Scientific Officer, NKF. “Our hope is that a home-based test makes it easier for patients at risk for CKD to comply with regular albuminuria screening, and that this will lead to earlier diagnosis and treatment of CKD, reducing cardiovascular risk and preserving kidney function,” added Dr. Willis.
The new trial will:
- Examine the effect of mailed, Healthy.io smartphone urinalysis kits (Dip.io test) to improve albuminuria screening compliance and detection of albuminuria.
- Examine the feasibility of pharmacists in improving management of detected albuminuria, as pharmacists will be instructed to confirm test with urine albumin/creatinine ratio and treat albuminuria.
- Randomize 1,000 non-diabetic patients with hypertension who are receiving primary care at Geisinger. Patients will be randomized into two groups; one group receiving the usual care and one group who will receive a mailed Healthy.io urinalysis kit.
- A home test will be mailed to 500 Geisinger patients who have been diagnosed with hypertension but who do not have diabetes, along with instructions for downloading the smartphone app, to determine if the patient also has CKD.
- Geisinger patients will receive a letter and phone call educating them on the importance of screening for proteinuria from a team of nurses within the organization’s Care Gaps department.
- Appropriate follow-up will then be managed by the patient’s primary care provider and care team.
- View a link to the product: https://healthy.io/urinalysis-products/
“Healthy.io is proud to pioneer its 'adherence as a service’ platform with such forward-looking institutions as Geisinger and the National Kidney Foundation,” said Yonatan Adiri, CEO of Healthy.io. “Our mission is to use advanced computer vision and patient centric design to let clinicians empower their patients at scale without additional cost or effort." He adds, "Like a Netflix for adherence we lean on the spread of digital technology and efficient logistics to offer on demand testing delivered directly to the home. With a smartphone in your pocket, the point of care becomes wherever you are.”
The new clinical trial, which gets underway this month was announced April 10 at NKF’s 2018 Annual Spring Clinical Meetings held from April 10-14 at the Austin Convention Center, Texas.
Kidney Disease Facts
30 million American adults are estimated to have chronic kidney disease—and most aren’t aware of it. 1 in 3 American adults are at risk for chronic kidney disease. Risk factors for kidney disease include diabetes, high blood pressure, heart disease, obesity and family history. People of African American, Hispanic, Native American, Asian or Pacific Islander descent are at increased risk for developing the disease. African Americans are 3 times more likely than Whites, and Hispanics are nearly 1.5 times more likely than non-Hispanics to develop end stage renal disease (kidney failure).
About National Kidney Foundation
The National Kidney Foundation (NKF) is the largest, most comprehensive and longstanding organization dedicated to the awareness, prevention and treatment of kidney disease. For more information about NKF visit www.kidney.org.
Healthy.io uses computer vision, machine learning and user centric design to turn the smartphone camera into a medical device. The company’s first the DIP Smartphone urinalysis device, enables lay users to conduct urinalysis at home with no quality compromise and securely share results with their clinician.
Geisinger is committed to making better health easier for the more than 1 million people it serves. Founded more than 100 years ago by Abigail Geisinger, the system now includes 10 hospital campuses, a health plan with more than half a million members, a research institute and the Geisinger College of Health Sciences, which includes schools of medicine, nursing and graduate education. With more than 25,000 employees and 1,700+ employed physicians, Geisinger boosts its hometown economies in Pennsylvania by billions of dollars annually. Learn more at geisinger.org or connect with us on Facebook, Instagram, LinkedIn and Twitter.