Study protocol for an open-label, single-arm, mixed methods feasibility study of the MWIQ AI-powered decision support tool for diabetes management in GP practices

TY - JOUR

T1 - Study protocol for an open-label, single-arm, mixed methods feasibility study of the MWIQ AI-powered decision support tool for diabetes management in GP practices

AU - Dickson, Jane

AU - Cunningham, Scott G

AU - Sainsbury, Chris

AU - Rutter, Martin K

AU - Kanumilli, N

AU - Pearson, Ewan

AU - Brodie, Doogie

AU - Stevens, Marryat

AU - Wake, Deborah J

AU - Conway, Nicholas

N1 - © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.

PY - 2025/10/5

Y1 - 2025/10/5

N2 - INTRODUCTION: Diabetes affects ~10% of the world's population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.METHODS AND ANALYSIS: The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.ETHICS AND DISSEMINATION: This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.TRIAL REGISTRATION NUMBER: ISRCTN17422256.

AB - INTRODUCTION: Diabetes affects ~10% of the world's population and is rising. Treatment costs in the UK are ~15% of the NHS budget. Diabetes-related complications can be lowered through better evidence-based clinician management and patient self-management. MyWay intelligence quotient (MWIQ) is an electronic platform that will provide clinical decision support around the diagnosis and treatment of patients with diabetes. This study evaluates the safety and clinical performance (clinical appropriateness/applicability, clinical impact and clinical usability) of MWIQ.METHODS AND ANALYSIS: The system will be implemented in real time in four to seven general practitioner (GP) practices. Clinicians with diabetes expertise will be recruited as validators, who will inspect records to ensure system robustness before use, and up to 14 healthcare professionals will use and evaluate the system.Quantitative and qualitative analyses will be triangulated to assess the MWIQ system. Assessment of clinical outcomes will be made using pseudonymised routinely collected clinical data, including adherence to quality performance indicators, diabetes diagnosis, diabetes investigations (eg, genetic testing), HbA1c, blood pressure, body mass index, cholesterol and foot risk score for the diabetes population concerned. Clinical and validator participants will also submit a weekly questionnaire, and these, along with interviews, which are scheduled during the testing process, will be analysed to provide data on the utility, safety and usability of the system.ETHICS AND DISSEMINATION: This study was approved, 08/01/2024, by the North of Scotland Research Ethics Committee (REC), IRAS project ID: 305267, REC, reference 23/NS/0134. The study has gained confidentiality advisory group (CAG) support (reference: 24/CAG/0002), medicines and healthcare products regulatory agency (MHRA) and health research authority (27/08/2024) approvals.Findings will be reported to (1) The funding body, (2) The participating GP practices, (3) The study PPIE group, (4) The MHRA to support a submission for recognition as a class 2 CE/UKCA marked device, (5) Presented at local, national and international conferences and (6) Disseminated by peer-reviewed publications.TRIAL REGISTRATION NUMBER: ISRCTN17422256.

KW - Humans

KW - Feasibility Studies

KW - General Practice

KW - Decision Support Systems, Clinical

KW - Diabetes Mellitus/therapy

KW - Artificial Intelligence

KW - United Kingdom

KW - DIABETES & ENDOCRINOLOGY

KW - Clinical Protocols

KW - eHealth

KW - Digital Technology

KW - Clinical Decision-Making

KW - Diabetes Mellitus, Type 2

UR - https://www.scopus.com/pages/publications/105017833167

U2 - 10.1136/bmjopen-2024-097644

DO - 10.1136/bmjopen-2024-097644

M3 - Article

C2 - 41047261

SN - 2044-6055

VL - 15

JO - BMJ Open

JF - BMJ Open

IS - 10

M1 - e097644

ER -