Clinical Safety and Risk Management

Tesu Health Ltd, a company incorporated and registered in England and Wales with company number 15275028 and whose registered office is at 9 Hills Road, Cambridge, England, CB2 1GE.

 

PreDiaWell^® is a digital therapeutic software application intended to be used by adult patients diagnosed with prediabetes, to develop lifestyle changes for the treatment of prediabetes. The app is a Medical Device classified as risk category I in accordance with Rule 12 of Chapter III of Annex IX of the Medical Device Directive (MDD) 93/42/EEC as per Part II of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). In the UK. Our MHRA account number is 31606.

 

PreDiaWell^® was developed by a multidisciplinary team that includes healthcare professionals with extensive experience in clinical practice and health technology and designed following industry standards for medical software, ensuring adherence to regulatory frameworks such as ISO 13485:2016 for quality management systems, IEC 62304:2006 for medical device software lifecycle processes, IEC 62366-1:2015 for application of usability engineering to medical devices and ISO 14971:2019 for application of risk management to medical devices. This compliance ensures that PreDiaWell^® maintains high standards in safety, quality, and effectiveness.

 

PreDiaWell^® employs several evidence-based methods for behaviour modification to help users adopt healthier lifestyle habits. These methods include:

• Goal Setting: Sets specific, achievable daily nutrition and physical activity goals. The app helps them track their progress and celebrate milestones, reinforcing positive behaviour changes.
• Self-Monitoring: Includes tools for users to track their progress through the app, which helps increase awareness of their behaviours and promotes accountability.
• Gamification: PreDiaWell^® uses gamification techniques, such as rewards, virtual scoreboards, and challenges, to make the behaviour change process engaging and motivating.
• Educational Materials: The app provides users with educational resources about nutrition, exercise, and healthy habits, helping them make informed choices.
• Notifications and Reminders: Users receive reminders and notifications to keep them engaged and on track with their goals, reinforcing the importance of consistency in behaviour change.
• Cognitive-Behavioural Approach: The app incorporates principles of cognitive-behavioural therapy to help users understand the connection between their thoughts, feelings, and behaviours. This approach encourages users to identify and change negative thought patterns related to eating and physical activity.

These methods collectively create a structured approach to behaviour modification, empowering users to make sustainable lifestyle changes to reduce their risk of developing diabetes and other chronic diseases.

 

Evidence base for the app

PreDiaWell^® has been developed with people, patients and healthcare professionals. The following evidence-base has been used as a foundation to develop the app and its contents:

• Aroda, V. R., & Ratner, R. (2008). Approach to the patient with prediabetes. The Journal of clinical endocrinology and metabolism, 93(9), 3259–3265. https://doi.org/10.1210/jc.2008-1091
• Knowler, W. C., Barrett-Connor, E., Fowler, S. E., Hamman, R. F., Lachin, J. M., Walker, E. A., Nathan, D. M., & Diabetes Prevention Program Research Group (2002). Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. The New England journal of medicine, 346(6), 393–403. https://doi.org/10.1056/NEJMoa012512
• Department of Health and Social Care. Physical Activity Guidelines: UK Chief Medical Officers’ Report. Department of Health and Social Care; London, UK: 2019. Available online: https://www.gov.uk/government/publications/physical-activity-guidelines-uk-chief-medical-officers-report
• Diabetes Prevention Program Research Group (2015). Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. The lancet. Diabetes & endocrinology, 3(11), 866–875. https://doi.org/10.1016/S2213-8587(15)00291-0
• National Institute of Diabetes and Digestive and Kidney Diseases. (2019). Diabetes Overview | NIDDK. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/diabetes/overview
• American Diabetes Association Professional Practice Committee (2024). 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes: Standards of Care in Diabetes-2024. Diabetes care, 47(Suppl 1), S77–S110. https://doi.org/10.2337/dc24-S005
• American Diabetes Association Professional Practice Committee (2024). 8. Obesity and Weight Management for the Prevention and Treatment of Type 2 Diabetes: Standards of Care in Diabetes-2024. Diabetes care, 47(Suppl 1), S145–S157. https://doi.org/10.2337/dc24-S008
• ‌National Institute for Health and Care Excellence. (2017). Type 2 diabetes: prevention in people at high risk | Guidance | NICE. Nice.org.uk; NICE. https://www.nice.org.uk/guidance/ph38
• American College of Sports Medicine (2016). Reducing Sedentary Behaviors: Sit Less and Move More. https://www.acsm.org/docs/default=source/files-for-resource-library/reducing-sedentary-behaviors-sitless-and-move-more.pdf
• Sit less, move more | Heart Foundation. (2024). Heartfoundation.org.au. https://www.heartfoundation.org.au/healthy-living/physical-activity/sit-less-move-more
• The American Diabetes Association. (2020). What is the Diabetes Plate? | American Diabetes Association. Diabetesfoodhub.org. https://diabetesfoodhub.org/blog/what-diabetes-plate
• Black P. H. (2003). The inflammatory response is an integral part of the stress response: Implications for atherosclerosis, insulin resistance, type II diabetes and metabolic syndrome X. Brain, behavior, and immunity, 17(5), 350–364. https://doi.org/10.1016/s0889-1591(03)00048-5
• Huang, C. J., Webb, H. E., Zourdos, M. C., & Acevedo, E. O. (2013). Cardiovascular reactivity, stress, and physical activity. Frontiers in physiology, 4, 314. https://doi.org/10.3389/fphys.2013.00314
• Hofmann, S. G., Sawyer, A. T., Witt, A. A., & Oh, D. (2010). The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. Journal of consulting and clinical psychology, 78(2), 169–183. https://doi.org/10.1037/a0018555
• Ma, X., Yue, Z. Q., Gong, Z. Q., Zhang, H., Duan, N. Y., Shi, Y. T., Wei, G. X., & Li, Y. F. (2017). The Effect of Diaphragmatic Breathing on Attention, Negative Affect and Stress in Healthy Adults. Frontiers in psychology, 8, 874. https://doi.org/10.3389/fpsyg.2017.00874
• Dempsey, P. C., Owen, N., Yates, T. E., Kingwell, B. A., & Dunstan, D. W. (2016). Sitting Less and Moving More: Improved Glycaemic Control for Type 2 Diabetes Prevention and Management. Current diabetes reports, 16(11), 114. https://doi.org/10.1007/s11892-016-0797-4
• Buckley, J. P., Hedge, A., Yates, T., Copeland, R. J., Loosemore, M., Hamer, M., Bradley, G., & Dunstan, D. W. (2015). The sedentary office: an expert statement on the growing case for change towards better health and productivity. British journal of sports medicine, 49(21), 1357–1362. https://doi.org/10.1136/bjsports-2015-094618
• Monteiro, C. A., Cannon, G., Moubarac, J. C., Levy, R. B., Louzada, M. L. C., & Jaime, P. C. (2018). The UN Decade of Nutrition, the NOVA food classification and the trouble with ultra-processing. Public health nutrition, 21(1), 5–17. https://doi.org/10.1017/S1368980017000234
• Ruffault, A., Czernichow, S., Hagger, M. S., Ferrand, M., Erichot, N., Carette, C., Boujut, E., & Flahault, C. (2017). The effects of mindfulness training on weight-loss and health-related behaviours in adults with overweight and obesity: A systematic review and meta-analysis. Obesity research & clinical practice, 11(5 Suppl 1), 90–111. https://doi.org/10.1016/j.orcp.2016.09.002
• Torres, S. J., & Nowson, C. A. (2007). Relationship between stress, eating behavior, and obesity. Nutrition (Burbank, Los Angeles County, Calif.), 23(11-12), 887–894. https://doi.org/10.1016/j.nut.2007.08.008
• Dakanalis, A., Mentzelou, M., Papadopoulou, S. K., Papandreou, D., Spanoudaki, M., Vasios, G. K., Pavlidou, E., Mantzorou, M., & Giaginis, C. (2023). The Association of Emotional Eating with Overweight/Obesity, Depression, Anxiety/Stress, and Dietary Patterns: A Review of the Current Clinical Evidence. Nutrients, 15(5), 1173. https://doi.org/10.3390/nu15051173
• Diabetes Prevention Program (DPP) Research Group (2002). The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes care, 25(12), 2165–2171. https://doi.org/10.2337/diacare.25.12.2165
• Gillies, C. L., Abrams, K. R., Lambert, P. C., Cooper, N. J., Sutton, A. J., Hsu, R. T., & Khunti, K. (2007). Pharmacological and lifestyle interventions to prevent or delay type 2 diabetes in people with impaired glucose tolerance: systematic review and meta-analysis. BMJ (Clinical research ed.), 334(7588), 299. https://doi.org/10.1136/bmj.39063.689375.55
• Grock, S., Ku, J. H., Kim, J., & Moin, T. (2017). A Review of Technology-Assisted Interventions for Diabetes Prevention. Current diabetes reports, 17(11), 107. https://doi.org/10.1007/s11892-017-0948-2
• Hori, J. H., Sia, E. X., Lockwood, K. G., Auster-Gussman, L. A., Rapoport, S., Branch, O. H., & Graham, S. A. (2022). Discovering Engagement Personas in a Digital Diabetes Prevention Program. Behavioral sciences (Basel, Switzerland), 12(6), 159. https://doi.org/10.3390/bs12060159
• Kirley, K., & Sachdev, N. (2018). Digital Health-Supported Lifestyle Change Programs to Prevent Type 2 Diabetes. Diabetes spectrum : a publication of the American Diabetes Association, 31(4), 303–309. https://doi.org/10.2337/ds18-0019
• Ramakrishnan, P., Yan, K., Balijepalli, C., & Druyts, E. (2021). Changing face of healthcare: digital therapeutics in the management of diabetes. Current medical research and opinion, 37(12), 2089–2091. https://doi.org/10.1080/03007995.2021.1976737
• Schimpl, M., Moore, C., Lederer, C., Neuhaus, A., Sambrook, J., Danesh, J., Ouwehand, W., & Daumer, M. (2011). Association between walking speed and age in healthy, free-living individuals using mobile accelerometry–a cross-sectional study. PloS one, 6(8), e23299. https://doi.org/10.1371/journal.pone.0023299
• Measuring Physical Activity Intensity | Physical Activity | CDC. (n.d.). https://www.cdc.gov/physicalactivity/basics/measuring/index.html

Clinical and technical safety

We are committed to clinical and technical excellence. Effective application of clinical risk management, clinical risk and safety is managed by the Tesu Health’s Executive Team with the Medical Research Manager, Dr. Ilker Tosun, taking the lead as the Clinical Safety Officer. Regular meetings are convened to review safety protocols, assess emerging risks, and evaluate the effectiveness of mitigation strategies.

 

The Clinical Safety Officer (CSO) for this app is Dr. Ilker Tosun and can be contacted at safety@tesuhealth.com.

 

The Data Protection Officer (DPO) is Gurkan Caner Birer and can be contacted at privacy@tesuhealth.com.

 

Risk management process

Tesu Health has risk management and clinical evaluation processes to evaluate the clinical benefits and risks and to determine the acceptability of the benefit-risk profile associated with the intended use, target population(s) and indication(s), while taking into account State of the Art.

 

The risk management process establishes criteria for risk acceptability following ISO 14971:2019 and ISO/TR 24971:2020. It applies to all people and activities involved in the design, development and distribution process of the medical device, and intends to ensure highest levels of medical device safety consistent with stakeholder expectations. Estimated usage, categories of severity / probability and risk acceptance matrix are defined based on applicable regulatory requirements, relevant international norms and standards, as well as the generally acknowledged state of the art (e.g. accepted results of scientific research, reports published by authorities, established industry best practices). All identified risks must be reduced as far as possible (AFAP) without adversely affecting the benefit-risk-ratio. Acceptability of the overall residual risk is established as part of the clinical evaluation process by weighing benefits from intended use against the overall residual risk.

 

Tesu Health continually monitors its services. The contents of the app are reviewed regularly by the Clinical Safety Officer, or as peer-reviewed evidence emerges. If you would like to raise a risk or hazard, please contact us at safety@tesuhealth.com

 

Risks associated with the app

Known and foreseeable clinical risks have been considered for the PreDiaWell^® in accordance with the risk management procedure and have been mitigated as far as possible (AFAP). Tesu Health has determined there are no residual clinical risks or undesirable side-effects (e.g., adverse effects, complications) to be conveyed to the patient via the PreDiaWell^® User Manual.

 

Tesu Health has also conducted a randomised controlled trial, and no adverse device effects reported during the study. Tesu Health continues to research the benefits and risks related to app use.

 

PreDiaWell^® does not interpret or make decisions on the data it conveys nor is it intended to provide automated treatment decisions or to be used as a substitute for professional judgement. All medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. The healthcare professional should be updated on any changes of medications or diagnoses with any new medical condition.

 

Please consult your doctor before using this app. The app is not intended to replace the relationship with your doctor/physician. Follow the advice of your doctor.