Advice

Clinical and technical evidence

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

The evidence for Healthy.io's albumin to creatinine ratio (ACR) product is from 1 single-arm observational study of 2,196 people with diabetes.

One randomised controlled trial (Leddy et al. 2019) and 1 conference abstract (Burke et al. 2019) with data on Healthy.io smartphone urine testing were also found. However, these studies were not included because they did not assess the ACR product specifically. Also, the abstracts involved indications which were outside the focus of this briefing (routine prenatal care and self-testing for urinary tract infections).

The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

The evidence for the ACR product is from a single-armed observational study in people with diabetes done in an NHS setting. It suggests that home-based ACR testing using the technology can help improve ACR screening compliance (compliance with home-based testing was shown to be over 70%). It also found that most people find the test easy to use and prefer ACR home testing to standard care. Study outcomes suggests that the technology is likely to be cost saving (around £2,000 per person over a patient's lifetime). This is when it is used for people with diabetes who have previously been non-compliant with standard ACR testing. Cost savings in the study were driven by an estimated increase in the number of chronic kidney disease (CKD) diagnoses and a reduction in end-stage renal disease cases.

There is no published evidence on the sensitivity and specificity of the test compared with standard care. However, the company have provided evidence to the US Food and Drugs Administration (from bench and clinical studies), collected during regulatory approval. This describes diagnostic accuracy compared with standard semi-quantitative testing. Published data from Shore et al. (2019) only reports on patient satisfaction and uptake of the test during a 1-month follow-up period. There is limited clinical evidence with long-term patient follow up evaluating the effect of the test on clinical outcomes. These outcomes could include time to diagnosis and treatment, and subsequent kidney and cardiovascular outcomes (such as the incidence of end-stage kidney failure, kidney dialysis and transplant, and cardiovascular events). The evidence base involves patients with diabetes who were previously non-compliant with standard ACR testing. There is limited published evidence for the ACR home test in other patient populations when ACR testing is also recommended.

Shore et al. (2019)

Study size, design and location

Single-arm observational study of 2,196 people with diabetes who had not had an ACR measurement reported in the last 18 months. Results from the clinical evaluation were used for economic modelling to assess the cost consequence of home urinalysis. Study was done in the UK.

Intervention and comparator(s)

Intervention: Healthy.io's ACR product.

No comparator.

Key outcomes

Of the 2,196 people contacted, 695 (32%) agreed to be sent a home urinalysis test kit. Of these, 72% completed and returned the test, within the 1‑month follow up. Of the 170 people who completed a usability survey, 92% said they found the test easy or very easy to use and only 3% said they preferred testing at the surgery compared with home testing. The study's cost modelling showed a cost saving with home urinalysis of £2,008 per person over a lifetime time horizon. This was because of increased CKD diagnosis and reduced progression to end-stage renal failure.

Strengths and limitations

The study provides real-world evidence for the use of home-based ACR testing within the NHS, and results are likely to be generalisable. It was a single-arm observational study and results are subject to confounding. No published diagnostic accuracy data was available, so diagnostic accuracy estimates were assumed to be the same as standard care semi-quantitative testing (based on unpublished data collected during regulatory approval). The cost of home ACR testing used in this study was £11, which differed slightly from the current cost of the test (£12.10). The company provided financial support for the manuscript. Uptake was measured as newly reported ACR results 1 month after the test kits were sent out. The study stated that patient follow up was started based on ACR results, but further details of this follow up were not reported.

Sustainability

The company states that the materials of the test kit are all recyclable and that the test could decrease patients' carbon emissions because of reduced travel time. There is no published evidence to support these claims.

Recent and ongoing studies