DiabetesMKT_EvalNCT05967312
The Minuteful Kidney Test Evaluation: A Randomised Controlled Trial
An observational study of Diabetes and Chronic Kidney Diseases, run by University of Leicester at 6 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Chronic Kidney Diseases
- What is being tested?
- Minuteful Kidney Test Kit
- How many people
- 163,560 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 18 Nov 2022to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The trial population are GP registered patients with a diabetes diagnosis in GP records where the GP practice delivers routine annual screening for CKD via an ACR test based on an anniversary date and follows-up patients with increased albuminuria to confirm a diagnosis of CKD. Eligible GP practices will be recruited to participate in the trial.
Who may be able to join
- Included in the roll out at the time of the trial
- Willing and able to participate
- Willing to be randomised to either intervention or usual care
- Willing to provide the necessary trial data extractions and allow the research team access to staff for qualitative elements of the research Exclusion Criteria
- Previous involvement with rollout of the Minuteful Kidney Test Kit
- Participant Eligibility Criteria:
Show all 28Show fewer
- Age > 18
- Registered with a GP practice involved in the rollout during the time of the evaluation.
- Diagnosed with diabetes (Type I / II) Exclusion Criteria
- National Data Opt-out of sharing for anything other than clinical care
- Eligibility Criteria to be offered the Minuteful Kidney Test Kit (for individuals in practices randomised to intervention only)
- In intervention practices only individuals who satisfy all the criteria will be offered the Minuteful Kidney Test Kit:
- Age > 18 years
- Registered with a GP practice involved in the rollout during the time of the evaluation
- Diagnosed with diabetes (Type I / II)
- Those non-compliant with standard ACR screening practices and eligible for annual tests
- Willing to perform a urine test at home
- Access to a smart phone
- An ability to understand written English Exclusion Criteria
- Pregnancy
- Care home residents
- Patients who are catheterised
- Patients who are on the end-of-life care pathway
- Additional Qualitative Process Evaluation Eligibility Criteria (for individuals in practices randomised to intervention only) :
- Willing and able to provide informed consent
- At home Minuteful Kidney Test received
- Willing and able to provide verbal consent for interview
- An ability to understand verbal and written English or access to language support through family and/or friends
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Mid and South Essex (ICB)
Essex
Leicester, Leicestershire and Rutland (ICB)
Leicester
North East London (ICB)
London
South East London (ICB)
London
North East and North Cumbria (NENC) - ICB
Newcastle
Somerset (ICB)
Somerset
About this study
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.
Read the detailed description
The National CKD Audit (2017) (1) identified that 11 million people in the UK are at risk of chronic kidney disease (CKD), a long-term irreversible deterioration in kidney function with occurrence being more common in those with diabetes. NICE CG182 and NICE QS05 define testing Albumin:Creatinine ratio (ACR) in at risk populations as critical from a clinical and cost point of view. Despite its importance in the prevention of kidney disease, ACR testing is the worst performing of all 9 NICE diabetes care processes with low screening rates among patients, making this a critical area for improvement. Home testing strategies may therefore be useful in improving proteinuria screening adherence, which the National CKD Audit (2017) (1) finding that up to 65% of people with diabetes have relevant annual urinary ACR tests.
The overarching aim of The Minuteful Kidney Test Evaluation
- https://healthy.io/services/kidney
- https://www.nhsx.nhs.uk/ai-lab/explore-all-resources/understand-ai/healthyio-smartphone-albuminuria-urine-self-testing/ is to increase the use of ACR testing to identify previously undiagnosed albuminuria in those with diabetes. The primary hypothesis is that there will be an increase in proportion of individuals screened in general practices utilising the Minuteful Kidney Test (plus usual care) compared with general practices delivering usual care alone; and that this will result in a higher proportion of previously undiagnosed CKD being diagnosed in individuals in the intervention practices. The suitability of the technology for widescale deployment will also be addressed by exploring differences in outcomes by baseline characteristics alongside the qualitative process evaluation which will also gain an understanding of the technology's application across the UK population through a mixed method evaluation.
Using a Cluster RCT design, randomisation will operate on a 1:1 basis with a 50% chance of a cluster being allocated to the intervention. 348 practices (clusters) are required, with one cluster added to each arm to account for any whole cluster drop out. The average cluster size will consist of 470 patients with DM, determined as constant by how many patients with DM are eligible for annual review. 348 GP practices would provide 80% power at the 5% significance level to detect an increase in rate of CKD from 3% in the control arm to 4.3% in the intervention arm. This would provide over 90% power at the 5% significance level to detect an absolute increase of 7% in ACR test rate in the intervention arm compared to control (65% to 72%). The calculations assumed an ICC of 0.05, a coefficient of variation to allow for variation in in cluster size of 0.128 (cluster size range of 360-600).
- Conditions
- Diabetes, Chronic Kidney Diseases
- Being tested
- Minuteful Kidney Test Kit
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minuteful Kidney Test KitDiagnostic test
The Minuteful Kidney Test is an Artificial Intelligence (AI) based innovative technology to enable people at risk of CKD to undertake an ACR test at home using smartphone technology
| Study group | Role | What they receive |
|---|---|---|
| Intervention: | Offered the Minuteful Kidney Test Kit Receives: Diagnostic Test: Minuteful Kidney Test Kit | |
| Control | Continue as standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a diagnosis of CKD
Measured: At 6 months follow up extraction
Proportion of patients with ACR test in the last 12 months
Measured: At 6 months follow up extraction (12 months preceding)
Secondary outcomes (3)
Proportion of patients with newly diagnosed CKD (i.e., since randomisation)
Measured: Between baseline and 6 months data extraction
Proportion of patients with albuminuria
Measured: At 6 months follow up extraction
Proportion of patients with newly diagnosed albuminuria (i.e., since randomisation)
Measured: Between baseline and 6 months data extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start18 Nov 2022
- Primary completionDec 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 163,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Midlands and Lancashire Commissioning Support Unit, NHSE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967312
- Sponsor's protocol ID
- 0849
- Other IDs
- AI_AWARD01813, 304493
- Acronym
- MKT_Eval
- Status last verified
- Mar 2023
- First submitted
- 31 Jan 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Minuteful Kidney Test Evaluation: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05967312
- Acronym / sponsor ID
- MKT_Eval / 0849
- Conditions
- Diabetes, Chronic Kidney Diseases
- Keywords
- Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163,560 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- NHS Midlands and Lancashire Commissioning Support Unit, NHSE
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The National CKD Audit (2017) (1) identified that 11 million people in the UK are at risk of chronic kidney disease (CKD), a long-term irreversible deterioration in kidney function with occurrence being more common in those with diabetes. NICE CG182 and NICE QS05 define testing Albumin:Creatinine ratio (ACR) in at risk populations as critical from a clinical and cost point of view. Despite its importance in the prevention of kidney disease, ACR testing is the worst performing of all 9 NICE diabetes care processes with low screening rates among patients, making this a critical area for improvement. Home testing strategies may therefore be useful in improving proteinuria screening adherence, which the National CKD Audit (2017) (1) finding that up to 65% of people with diabetes have relevant annual urinary ACR tests.
The overarching aim of The Minuteful Kidney Test Evaluation
- https://healthy.io/services/kidney
- https://www.nhsx.nhs.uk/ai-lab/explore-all-resources/understand-ai/healthyio-smartphone-albuminuria-urine-self-testing/ is to increase the use of ACR testing to identify previously undiagnosed albuminuria in those with diabetes. The primary hypothesis is that there will be an increase in proportion of individuals screened in general practices utilising the Minuteful Kidney Test (plus usual care) compared with general practices delivering usual care alone; and that this will result in a higher proportion of previously undiagnosed CKD being diagnosed in individuals in the intervention practices. The suitability of the technology for widescale deployment will also be addressed by exploring differences in outcomes by baseline characteristics alongside the qualitative process evaluation which will also gain an understanding of the technology's application across the UK population through a mixed method evaluation.
Using a Cluster RCT design, randomisation will operate on a 1:1 basis with a 50% chance of a cluster being allocated to the intervention. 348 practices (clusters) are required, with one cluster added to each arm to account for any whole cluster drop out. The average cluster size will consist of 470 patients with DM, determined as constant by how many patients with DM are eligible for annual review. 348 GP practices would provide 80% power at the 5% significance level to detect an increase in rate of CKD from 3% in the control arm to 4.3% in the intervention arm. This would provide over 90% power at the 5% significance level to detect an absolute increase of 7% in ACR test rate in the intervention arm compared to control (65% to 72%). The calculations assumed an ICC of 0.05, a coefficient of variation to allow for variation in in cluster size of 0.128 (cluster size range of 360-600).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: | – | Diagnostic Test: Minuteful Kidney Test KitOffered the Minuteful Kidney Test Kit |
| Control | – | –Continue as standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The trial population are GP registered patients with a diabetes diagnosis in GP records where the GP practice delivers routine annual screening for CKD via an ACR test based on an anniversary date and follows-up patients with increased albuminuria to confirm a diagnosis of CKD. Eligible GP practices will be recruited to participate in the trial.
Key inclusion criteria (28 listed)
- Included in the roll out at the time of the trial
- Willing and able to participate
- Willing to be randomised to either intervention or usual care
- Willing to provide the necessary trial data extractions and allow the research team access to staff for qualitative elements of the research Exclusion Criteria
- Previous involvement with rollout of the Minuteful Kidney Test Kit
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minuteful Kidney Test KitThe Minuteful Kidney Test is an Artificial Intelligence (AI) based innovative technology to enable people at risk of CKD to undertake an ACR test at home using smartphone technology | Diagnostic test | Intervention: |
Primary outcome
Proportion of patients with a diagnosis of CKD
Time frame: At 6 months follow up extraction
Proportion of patients with ACR test in the last 12 months
Time frame: At 6 months follow up extraction (12 months preceding)
3 secondary outcomes
Proportion of patients with newly diagnosed CKD (i.e., since randomisation)
Time frame: Between baseline and 6 months data extraction
Proportion of patients with albuminuria
Time frame: At 6 months follow up extraction
Proportion of patients with newly diagnosed albuminuria (i.e., since randomisation)
Time frame: Between baseline and 6 months data extraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Chronic Kidney Diseases, run by University of Leicester at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a diagnosis of CKD (time frame: At 6 months follow up extraction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.