Summary:
A pilot program using Healthy.io’s FDA-cleared smartphone-powered Minuteful Kidney test significantly improved chronic kidney disease (CKD) screening, diagnosis, and follow-up among high-risk Geisinger patients compared to standard care.

Takeaways:

  1. Higher Screening Rates: The home uACR test led to a 2.5-fold increase in screening completion (53.1% vs. 21.2%) compared to standard care.
  2. Improved Diagnosis and Follow-Up: Pilot participants had higher CKD/proteinuria diagnosis rates (4.7% vs. 2.9%) and follow-up with primary care or nephrology visits.
  3. Medication Uptake Increased: Individuals with elevated uACR were more likely to receive new prescriptions for kidney-protective medications (ACEi/ARBs and SGLT2 inhibitors).

Healthy.io, a provider transforming the smartphone camera into a medical device; Geisinger, a provider of value-based care; and Boehringer Ingelheim, a research-driven biopharmaceutical company, today announced data demonstrating the longitudinal impact of a novel chronic kidney disease (CKD) screening pilot program.

The study, supported by Boehringer Ingelheim, included 4,000 patients from Geisinger with diabetes and/or hypertension, two prominent risk factors for CKD. Patients in the pilot group received either Healthy.io’s Minuteful Kidney smartphone-powered urine albumin-to-creatinine ratio (uACR) home test or a standard laboratory test, accompanied by patient outreach. The pilot group was compared to a 1:1 propensity-score-matched control group that received usual care (standard, routine healthcare services). Previously reported results revealed a significant 2.5-fold increase in uACR completion rates (53.1% vs. 21.2%, p<0.001) in the pilot group vs. control group.

CKD Screening Study Findings Presented at ADA Meeting

Findings presented at the American Diabetes Association (ADA) 85th Scientific Sessions on June 20, 2025, demonstrate that over a 270-day follow-up period, patients in the pilot group were more likely to receive a diagnosis related to CKD or proteinuria than those in the usual care arm (4.7% vs. 2.9%, p<0.001).

Based on results of the Minuteful Kidney test, individuals with an elevated uACR (≥30 mg/g) were more likely to complete a primary care follow-up visit (95.3% vs. 92.9%, p<0.001) or a nephrology visit (7.2% vs. 1.7%, p<0.001) compared to those with a normal uACR (< 30 mg/g). Additionally, there were a higher proportion of new ACEi/ARB prescriptions (7.5% vs. 4.4%, p=0.024) or new SGLT2i prescriptions (4.1% vs. 2.7%, p=0.054) for individuals with elevated uACR (≥30 mg/g) compared to those with uACR <30mg/g, indicating the importance of identifying albuminuria.

“Closing the uACR testing gap by reaching untested at-risk populations remains a top priority,” says Geoff Martin, CEO of Healthy.io. “These study results demonstrate how smartphone-enabled testing and education can enhance CKD screening compliance, which ultimately has the potential to improve patient outcomes. We value the collaboration with Geisinger and Boehringer Ingelheim as we work to close a care gap by supporting earlier identification of CKD through screening those identified as at risk of disease.”

“Detecting CKD early is crucial, as timely intervention can help mitigate the risk of disease progression and cardiovascular complications,” says Brian DiDonato, senior vice president, Cardio-Renal-Metabolic Brands at Boehringer Ingelheim. “We are proud to support this important study of Healthy.io’s Minuteful Kidney program, which presents an innovative approach to address the urgent need for enhanced CKD screening.”

“uACR testing is critical for evaluating kidney health and risk of cardiovascular events such as myocardial infarction or stroke,” says Alexander Chang, M.D., MS, Associate Professor from the Department of Population Health Sciences at Geisinger. “Given the increased rates of engagement, testing and follow-up care shown in this study, we are excited about the potential for the Minuteful Kidney program to drive earlier diagnosis rates and help make a direct, positive impact on patients’ lives.”

Limited Awareness, Lack of Access Lead to Poorer Outcomes

Limited awareness of, and access to, comprehensive screenings often contribute to poorer outcomes, emphasizing the urgent need for innovative solutions. Minuteful Kidney is the only FDA-cleared, smartphone-enabled home uACR test for CKD, allowing patients to receive clinical-grade results within minutes. As a part of the pilot program, participants in the pilot group received education via the Healthy.io engagement team. For those completing the Minuteful Kidney test, the associated app provided additional education regarding testing and supported follow-up and results sharing with healthcare providers. The pilot program demonstrated how a home testing approach can complement and help remove barriers to care.

Featured Image: Nils Ackermann | Dreamstime.com