MKT_EVAL
Research type
Research Study
Full title
The Minuteful Kidney test Evaluation: A Randomised Controlled Trial
IRAS ID
304493
Contact name
Gavin Murphy
Contact email
Sponsor organisation
University of Leicester
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Summary of Research
Chronic Kidney Disease (CKD) is a long-term condition in which the ability of the kidneys to function gets worse over time. People with CKD often do not have associated symptoms, meaning that it is possible for the condition to go undetected until the condition worsens and symptoms develop. The disease is more common in people with diabetes and screening by means of urine and blood tests is recommended in this population by The National Institute for Health and Care Excellence (NICE) Guidelines in order to detect disease earlier. However, screening rates amongst these patients are low and the dilemma is therefore how to increase the rate of screening in those who are ordinarily non-compliant. It is thought that facilitating patients in being able to perform The Minuteful Kidney Test (an at home test using smartphone technology) may increase the amount of people that undertake the test and thus improving early detection. 348 GP practices will be randomised in clusters, meaning that the GP practice will be randomised rather than the individual patient. This type of trial design is common in public health research as it is particularly suited to testing differences in approaches towards patient care. Each cluster will consist of on average 470 patients with diabetes. Each cluster will be allocated at random to either issuing The Minuteful Kidney Test (plus usual care) or usual care alone. This allocation will be applicable to each patient within that cluster. The evaluation will tell us whether administering this test increases the diagnosis rates of CKD as well as the frequency at which the test is performed in patients with diabetes. The results of the evaluation will determine whether The Minuteful Kidney Test should be used instead of or alongside existing blood and urine tests in this particular group of patients.Summary of Results
The Minuteful Kidney Test Evaluation: A Randomised Controlled Trial (MKT_Eval).
People living with diabetes are at a high risk of developing Chronic Kidney Disease (CKD). One of the earliest warning signs of kidney damage is an elevated level of protein in the urine, which can be found using an Albumin:Creatinine Ratio (ACR) urine test. Despite official medical guidelines highlighting this annual test as critical, it is often not performed, leaving nearly half of the at-risk population untested and undiagnosed.Research was urgently needed to see if giving patients an easy option to test their urine at home using a smartphone app would bridge this gap and find undiagnosed kidney disease early.
The study was managed by the Leicester Clinical Trials Unit at the University of Leicester, which acted as the official study sponsor. A qualitative study (interviews and patient feedback) was run by The Strategy Unit (part of the NHS Midlands and Lancashire Commissioning Support Unit).
Funding: The project was funded by the NHS England Accelerated Access Collaborative under an Artificial Intelligence (AI) Award.
The researchers actively collaborated with the University of Leicester Lifestyle Patient and Public Involvement (PPI) group. This group is broadly made up of people with lived experience in Type II diabetes and kidney conditions. They helped design data collection methods, refined the feedback questions used in the smartphone app, and shaped the wider qualitative research approach.
The trial focused on two main questions:
Does offering the home test kit increase the percentage of diabetic patients who get an ACR urine screening?
Does offering the home test kit increase the overall percentage of patients successfully diagnosed with CKD?
The trial took place across 238 General Practices (GPs) spanning 11 different regional healthcare boundaries (sub-ICBs) in England. Patient recruitment and tracking began with the first practice randomisation on 18 January 2023 and concluded following final data collection after 9 May 2024.
Participants were adults (aged 18 or older) diagnosed with Type I or Type II diabetes registered at the participating GP practices. At baseline and 6 months, data from over 110,000 patients were analysed. The average participant had a median age of 66, and the majority (87.8%) had Type II diabetes.
GP practices were split into two groups:
Usual Care (Control Group): Patients received standard care, meaning they were given a routine annual invitation to bring a physical urine sample into the clinic for laboratory analysis.
The Minuteful Kidney Test (Intervention Group): patients more than 13 months overdue for their annual check, were offered a specialised home testing kit. Patients used a smartphone app to scan a standard testing dipstick. An AI algorithm inside the app analysed the colour change to read the protein level, a second confirmatory test was completed for positive ACR at the practice.
At the 6-month mark, researchers securely pulled de-identified data logs from both groups to count how many tests were completed and new diagnoses were made.
Key results of the study:
Testing Uptake: Patients in the home-testing group had a higher testing rate (61.0%) compared to the standard care group (55.2%). However, statistical models revealed that this overall difference was small enough that it could still be attributed to chance.
CKD Diagnosis: The overall rates of diagnosed CKD remained similar between the two arms (21.0% vs 21.2%).
Important Subgroup Finding: The home kit did significantly increase testing rates for patients under the age of 65 although no significant increase in CKD diagnosis was found in this age group.Minuteful Kidney Test is a completely non-invasive, simple home urine test, there was no medication or physical procedure involved. No adverse reactions or physical risks were expected or recorded throughout the trial.
The trial shed light on real-world numbers: baseline testing rates across the NHS were lower, and existing kidney disease numbers were higher than previous smaller studies estimated. For researchers, it highlighted major structural limitations. The trial ultimately became "underpowered" meaning fewer GP practices participated than originally planned, and several clinics faced significant delays rolling out the technology. This teaches future researchers that digital health rollouts require stronger structural incentives and dedicated funding for GPs to ensure consistent data collection.
The trial shows an increase in testing with the use of MKT in patients under 65. Future research should focus on targeting younger demographics who are more tech-literate or assessing ways to make the technology more accessible to older individuals.
You can look up further scientific updates and registry logs for this specific trial on the international database ClinicalTrials.gov using the unique identifier: NCT05967312.
REC name
North West - Preston Research Ethics Committee
REC reference
22/NW/0123
Date of REC Opinion
27 Jun 2022
REC opinion
Further Information Favourable Opinion