Healthy.io, Geisinger and Boehringer Ingelheim Reveal Milestone Data at AHA 2024

The collaboration's research demonstrates how smartphone technology achieved a 2.5x increase in testing rates, offering a promising solution for early CKD identification 

BOSTON, Sept. 10, 2024 /PRNewswire/ -- In a leap forward for chronic kidney disease (CKD) screening, Healthy.io, the global leader in transforming the smartphone camera into a medical device, Geisinger, one of the nation's leading providers of value-based care, and Boehringer Ingelheim, a leading research-driven biopharmaceutical company, announced results from a new two-phased study aimed at improving the identification of CKD in at-risk individuals, many of whom suffer from type 2 diabetes or hypertension.

Phase 1 of the study revealed that CKD testing adherence more than doubled when using a smartphone-enabled home albuminuria test compared to traditional methods. These findings were presented at the American Heart Association's (AHA) Hypertension Scientific Sessions on September 6th, 2024.

CKD is a national health crisis affecting more than 35 million Americans, with approximately 90% of people with CKD not knowing they have it. Despite 1 in 3 individuals being at risk, less than 20% complete the guideline-recommended urine albumin-creatinine ratio (uACR) test, an early indicator to detect CKD. Adherence to testing is especially low in individuals with hypertension. While new treatments are available, limited awareness of and access to screenings often lead to late diagnosis and poorer outcomes, emphasizing the urgent need for innovative solutions.

The study included 3,998 Geisinger patients identified as at-risk due to type 2 diabetes or hypertension and who had not completed a uACR test in the last year. These patients were provided with Healthy.io's Minuteful Kidney™, the only FDA-cleared, smartphone-enabled home uACR testing kit and app. Supported by Boehringer Ingelheim, this collaborative study evaluated the adherence to testing of Minuteful Kidney compared to usual care in improving CKD testing for at-risk individuals. 

Phase 1 concluded in June with the Healthy.io intervention arm achieving a 53.1% uACR test completion rate across at-risk, previously untested patients, representing a substantial 2.5x improvement vs. the usual care propensity matched cohort at 21.3% completion rate. Within the Healthy.io intervention arm, 38.9% completed the Minuteful Kidney smartphone uACR test, and 14.2% went on to complete a lab uACR after program outreach and education.

The impact of the intervention was particularly notable in the hypertension subgroup, which saw a marked increase in uACR testing rates (53.4% in the intervention arm vs. 12.5% in the usual care group), compared to the type 2 diabetes subgroup (52.7% vs. 30.0%). The detection of abnormal results was also similar across patients with either hypertension or type 2 diabetes, underscoring the critical role of albuminuria testing in identifying CKD risk associated with hypertension.

Patients who received abnormal results from the Minuteful Kidney test were supported with appropriate next steps via the app. Results were also transferred to the Geisinger EMR, facilitating real-time patient management and follow-up care. The test was well-received by participants, with 94% of patients rating the home test easy to complete, and 88% stating a preference for home-testing.

Preliminary data from Phase 2 shows that 66% of individuals who received abnormal results used an in-app scheduling feature from Minuteful Kidney to schedule an appointment with their Geisinger primary care physician. 

Ultimately, this promising data shows that a population health approach using smartphone-enabled home uACR testing is effective in increasing screening and follow-up care among individuals with type 2 diabetes or hypertension. By identifying CKD earlier and ensuring timely intervention, this approach will contribute to better disease management and improved long-term outcomes. Additional data from this collaboration will be reported shortly after the Phase 1 Data presentation at AHA Hypertension 24' by Dr. Alexander Chang, MD, MS, Associate Professor from the Dept. of Population Health Sciences at Geisinger.

"We are excited to partner with Geisinger and Boehringer Ingelheim to demonstrate how smartphone-enabled testing can contribute to patient care and health outcomes. The study's results underscore the substantial improvement in test completion rates and highlight the potential for new technology to transform the landscape of CKD screening and chronic conditions management," said Geoff Martin, CEO of Healthy.io.

"Early detection of CKD is critical to reducing long-term complications. Healthy.io's mission to increase access to testing and empower those at risk to take a proactive approach to their kidney health is needed," said Brian DiDonato, Senior Vice President, Cardio-Renal-Metabolic Brands at Boehringer Ingelheim. "90% of those with CKD are undiagnosed, and these data represent the potential to further increase diagnosis rates for the proper management of the disease."

"Any opportunity to improve early detection of kidney disease is very important for our patients. I am pleased to see that the Minuteful Kidney test was used by many of our patients, including folks from rural and urban areas, and older and younger individuals," said Dr. Chang. "The patient engagement with Minuteful Kidney was impressive, and we are seeing substantial follow-up care being provided to patients who tested positive for albuminuria."

About Healthy.io
Healthy.io transforms the smartphone camera into a medical device to deliver healthcare at the speed of life. The company's at-home urinalysis and digitized wound care services enable providers and healthcare systems to close gaps in access and care while increasing patient satisfaction. Healthy.io is a global leader in digital health and is a recipient of the 2023 MedTech Breakthrough 'Best In-Home Testing Solution' Award and the Juniper Research's Digital Health Innovation 'Best Digital Diagnostics Solution' 2023 Award. The company has offices in Boston, London, and Tel-Aviv.

About Geisinger
Geisinger is among the nation's leading providers of value-based care, serving 1.2 million people in urban and rural communities across Pennsylvania. Founded in 1915 by philanthropist Abigail Geisinger, the nonprofit system generates $10 billion in annual revenues across 126 care sites — including 10 hospital campuses — and Geisinger Health Plan, with more than half a million members in commercial and government plans. Geisinger College of Health Sciences educates more than 5,000 medical professionals annually and conducts more than 1,400 clinical research studies. With 26,000 employees, including 1,700 employed physicians, Geisinger is among Pennsylvania's largest employers with an estimated economic impact of $15 billion to the state's economy. On March 31, 2024, Geisinger became the first member of Risant Health, a new nonprofit charitable organization created to expand and accelerate value-based care across the country. Learn more at geisinger.org or follow on Facebook, Instagram, LinkedIn and X.

About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at boehringer-ingelheim.com/us/

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SOURCE Healthy.io