Title: User needs analysis and technical de-risking of personalised potassium monitoring
Funder: Department of Health and Social Care

Abstract: Worldwide, around 1 in 10 people are living with Chronic Kidney Disease. For these people, management of blood potassium levels is crucial, as severe high or low potassium levels lead to problems with heart rhythm, paralysis or even death. Kidney patients such as these are not currently able to measure their blood potassium levels without visiting their GP or a hospital. There, a nurse must collect a blood sample from a vein in the patient s arm and send it away for laboratory analysis. This inconvenience and delay means that tests can be missed or results arrive too late, putting the patient at risk. At Kalium Health we are developing the world s first blood potassium self-test. This will empower millions of people with kidney and other diseases to manage their health at home. Our test kit includes a pocket-sized electronic reader and single-use test strips. The user pricks their finger and places a tiny drop of blood onto the test strip. The reader measures the potassium level and displays the result within a few seconds, meaning the patient or care provider can take action if the reading is too high or low. The action will depend on the particular patient but could include seeking emergency medical help or making immediate changes to diet or medication. Our innovation is particularly timely as a new class of rapid potassium-lowering drugs has recently become available, providing the opportunity for our test to be a key tool in personalised medicine. This project aims to extend our research and development to include activities that are important for future adoption by the NHS: Engaging with potential users of the test kit to ensure the design meets their needs and preferences; Proving that our finger-prick blood collection technique provides a good quality sample for our test. The project is structured as two technical Work Packages and a further Work Package of project management, reporting and public/patient involvement. We will engage with patients throughout the project including meeting regularly with patient representatives to review progress and take on board their suggestions. We have an extensive online network of patients and the public which we use as an input into our strategy and product design. The project will run from January to November 2021 and we plan to seek marketing approval for the test kit in 2022, launching for UK patients the following year. This funding will ensure the needs of English patients are addressed and that the product will be suitable for adoption by the NHS where we have seen the need for this test at first hand. Home blood potassium monitoring will empower patients to manage their own health, reduce their risk and save costs for the NHS.

Lay abstract: Worldwide, around 1 in 10 people are living with Chronic Kidney Disease. For these people, management of blood potassium levels is crucial, as severe high or low potassium levels lead to problems with heart rhythm, paralysis or even death. Kidney patients such as these are not currently able to measure their blood potassium levels without visiting their GP or a hospital. There, a nurse must collect a blood sample from a vein in the patient s arm and send it away for laboratory analysis. This inconvenience and delay means that tests can be missed or results arrive too late, putting the patient at risk. At Kalium Health we are developing the world s first blood potassium self-test. This will empower millions of people with kidney and other diseases to manage their health at home. Our test kit includes a pocket-sized electronic reader and single-use test strips. The user pricks their finger and places a tiny drop of blood onto the test strip. The reader measures the potassium level and displays the result within a few seconds, meaning the patient or care provider can take action if the reading is too high or low. The action will depend on the particular patient but could include seeking emergency medical help or making immediate changes to diet or medication. Our innovation is particularly timely as a new class of rapid potassium-lowering drugs has recently become available, providing the opportunity for our test to be a key tool in personalised medicine. This project aims to extend our research and development to include activities that are important for future adoption by the NHS: Engaging with potential users of the test kit to ensure the design meets their needs and preferences; Proving that our finger-prick blood collection technique provides a good quality sample for our test. The project is structured as two technical Work Packages and a further Work Package of project management, reporting and public/patient involvement. We will engage with patients throughout the project including meeting regularly with patient representatives to review progress and take on board their suggestions. We have an extensive online network of patients and the public which we use as an input into our strategy and product design. The project will run from January to November 2021 and we plan to seek marketing approval for the test kit in 2022, launching for UK patients the following year. This funding will ensure the needs of English patients are addressed and that the product will be suitable for adoption by the NHS where we have seen the need for this test at first hand. Home blood potassium monitoring will empower patients to manage their own health, reduce their risk and save costs for the NHS.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: RENAL AND UROGENITAL