The National Kidney Foundation (NKF), Danville, Pa.-based health system Geisinger and Healthy.io have launched a 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, according to a Geisinger press release.
Healthy.io is a health technology company based in Tel Aviv, Israel that uses computer vision, machine learning and user-centric design to turn the smartphone camera into a clinical-grade medical device.
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, according to Geisinger officials.
“Early detection of CKD is crucial so that risk factors can be aggressively managed to prevent end-stage renal disease and cardiovascular disease,” Alexander Chang, M.D., practicing nephrologist and assistant professor in the Kidney Health Research Institute at Geisinger, said in a statement.
“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,” Kerry Willis, Ph.D., chief scientific officer, NKF, said. “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.”
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 and 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.
What’s more, the clinical trial will also 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.
“Healthy.io is proud to pioneer its 'adherence as a service’ platform with such forward-looking institutions as Geisinger and the National Kidney Foundation,” Yonatan Adiri, Healthy.io CEO, said in a statement. “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. 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.