With an increasing global prevalence of type 2 diabetes (T2D), particularly among elderly populations, the need for appropriate diabetes management is of paramount importance. However, issues related to over-prescription of medications have sparked significant attention due to their potential to cause adverse health events. This attention has subsequently brought to light the concept of medication deintensification, a process of scaling back the use of potentially inappropriate medications (PIMs), which is gaining traction in the healthcare sector.
Spearheading this initiative is the D-MED study, a landmark protocol for a cluster randomised controlled trial aimed at evaluating the deintensification of PIMs amongst older, frail individuals with T2D. At its core, the study plans to focus on the implications of employing a highly anticipated electronic decision-support system coupled with comprehensive training for healthcare providers in primary care settings.
The stark reality highlighted by the D-MED study is the urgent need to shift from a historical emphasis on medication intensification to a much-needed patient-specific approach that incorporates deintensification when necessary. Such a paradigm shift is expected to reduce the prevalence of emergency medical responses, falls, fractures, and increased mortality rates closely linked to the over-prescribing phenom within this vulnerable population segment.
This transformative study is led by several esteemed researchers, including Lauren L. O’Mahoney, Patrick P. Highton, Ruksar R. Abdala, and Kamlesh K. Khunti from the University of Leicester’s acclaimed Diabetes Research Centre, in conjunction with the National Institute for Health Research Applied Research Collaboration East Midlands.
This open-label, multi-site, pragmatic cluster-randomised trial has already begun recruiting from primary GP practices and will utilize a two-armed approach. Practices allocated to the ‘enhanced care’ group will see the implementation of the state-of-the-art electronic decision support system that aims to identify eligible patients and facilitate deintensification by aligning healthcare professional’s actions with a clinical algorithm.
The study is significant, not only for its potential to improve patient outcomes but for the pioneering digital approach it brings to primary diabetes care. Preliminary data has been collected from 40 practices, spanning a patient demographic of 3,145. This data serves as a baseline for the effectiveness of the electronic decision support system in guiding the medication management process.
The study’s lead date was January 14, 2024, as published in the “Primary Care Diabetes” journal with an International Standard Randomised Controlled Trial Number: ISRCTN53221378. The results will promise to be a significant contribution to the body of research on diabetes treatment, with a primary outcome focusing on the number of de-intensified PIMs at the 12-month milestone.
While it’s true that digital technology comes with the potential to enhance medication management, the implications of this specific system may widen the scope of practice for healthcare professionals; it empowers them to make well-informed decisions for the de-intensification of diabetes medications, thus promoting the safe removal of unnecessary therapy.
The D-MED study commences against a backdrop of various financial conflicts of interest. It is necessary to acknowledge the competing interests declared by researchers such as Kamlesh K. Khunti, who has previously acted as a consultant and speaker for numerous pharmaceutical companies, and Samuel S. Seidu, who has received funds for consultancy and research from various entities within the pharmaceutical industry. These declarations underline the intricate relationship between academic research and the pharmaceutical industry.
Moreover, the funding and support for this research are also richly backed by the Wellcome Trust, the National Institute for Health Care Research, and the British Heart Foundation among others.
In conclusion, the D-MED study is poised to make significant strides in improving the quality of diabetes care for elderly populations through medication deintensification, relying on the innovative use of digital technology. If successful, this could mark a new chapter in the era of tailored diabetes treatment, focused on patient safety and reducing the risks associated with over-prescription while enhancing the overall quality of life for older adults with T2D.
For more information on this groundbreaking study, please consult DOI: 10.1016/j.pcd.2023.12.001.
References
1. O’Mahoney, L. L., Highton, P. P., Abdala, R. R., Dallosso, H. H., Gillies, C. L., Ragha, S. S., … & Seidu, S. (2024). Deintensification of potentially inappropriate medications amongst older frail people with type 2 diabetes: Protocol for a cluster randomised controlled trial (D-MED study). Primary Care Diabetes. DOI: 10.1016/j.pcd.2023.12.001
2. American Diabetes Association. (2020). Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. Clinical Diabetes, 38(1), 10-38.
3. Mannucci, E., Monami, M., & Lamanna, C. (2009). Prevention of type 2 diabetes mellitus. International Journal of Clinical Practice, 63(3), 381-393.
4. Sinclair, A. J., et al. (2020). A position statement on the management of older adults with type 2 diabetes. The Lancet Diabetes & Endocrinology, 8(2), 131-142.
5. Tinetti, M. E., et al. (2018). Designing and evaluating interventions to prevent serious fall-related injuries in older adults: A framework for action. JAMA Internal Medicine, 178(1), 50-59.
Keywords
1. Medication Deintensification
2. Diabetes Care for Elderly
3. Type 2 Diabetes Management
4. Digital Decision-Support Systems
5. Primary Care Diabetes Trial