Four single arm observational studies in the UK focused on people with diabetes who were not following standard ACR testing. There was variability in the proportion of eligible patients agreeing to take part in home testing (32% to 91%). A high proportion of patients contacted agreed to participate (ranging from 72% to 78%) and, of those consenting to receive the test kit, between 71% and 89% went on to complete the test.
- The main reasons for non-participation were not having access to a smartphone and preferring to have the test at the GP surgery.
- Across studies, the proportion of patients recording a positive (abnormal or high abnormal) test result ranged from 23% to 25%.
- Patient satisfaction amongst those using the test was high. Between 92% and 98% of users found it easy or very easy to use and 84% to 97% expressed that their preference was for home testing.
- Two studies provided views of healthcare staff. The challenges in following up abnormal test results in patients who did not routinely engage with primary care was noted.
- No safety issues were identified.
Two cost-consequence analyses based on one model concluded that Minuteful Kidney is likely to be cost saving when compared with usual care. These findings rely on assumptions of test results being appropriately followed up with repeat testing, monitoring and, where required, treatment to prevent ESRD.
To derive benefit from using the technology in the long term, adequate and appropriate follow up is needed for patients with positive tests.
What were we asked to look at
Minuteful Kidney is a smartphone-based diagnostic home urine test for the semi-quantitative detection of microalbumin and creatinine, and the qualitative measurement of the ratio between them (albumin-to-creatinine ratio, ACR).
The test allows people with diabetes, high blood pressure or other risk factors for chronic kidney disease (CKD) to test their urine at home and receive immediate results. Findings are automatically logged on their electronic medical record and sent to their healthcare practitioner for follow up as required.
Why is this important
NICE recommends that people at increased risk of CKD require regular urine tests to allow early identification and treatment of CKD, reducing rates of end stage renal disease (ESRD). Current practice involves the patient taking a urine sample to the GP practice for laboratory analysis. Uptake of the test is low leaving many cases of CKD undetected.