M3

The impact of a holistic multifactorial management intervention in adults with early-onset type 2 diabetes (aged 16 to 45 years): The M3 randomised controlled trial.

Funding and sponsorship

This project is funded by the National Institute of Health Research (NIHR) under its Programme Grants for Applied Research (NIHR201165). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funding began on 01/03/2021 and ends on 28/02/2026. Additionally, the project is sponsored by University of Leicester.

Background

In the past, type 2 diabetes (T2D) mostly affected older adults, but recently, the number of people being diagnosed at a younger age has increased. This ‘early-onset’ T2D is associated with faster development of other associated health conditions, including obesity and high blood pressure, as well as those relating to people’s mental health and wellbeing, such as anxiety or depression.

Early treatment and self-management can reduce the risk of health problems developing. However, early-onset T2D care is currently the same as for older adults. Because younger adults likely have different needs, a new approach to care specifically for people with early-onset T2D is required to increase engagement.

The aim of the study is to design and develop a new multifactorial approach to care specifically tailored for people with early-onset T2D. This will involve working with individuals living with early-onset T2D, health care professionals, and decision-makers for the NHS. The effectiveness and cost-effectiveness of the intervention will then be tested in a large clinical trial.

Study aims

The programme includes three work packages (WP).

  • WP1 will use existing data and previously published evidence to explore long-term health outcomes of people with early-onset T2D and the effectiveness of existing therapies.

  • In WP2, the M3 intervention will be developed using evidence from WP1, a distinct qualiatative research study, and a variety of patient and public involvement and engagement (PPI/E) activities including people living with early-onset T2D, healthcare providers, and other stakeholders. Specifically, opinions of current care provision for early-onset T2D and preferences for design and content will be considered.

  • WP3 will test the effectiveness and cost-effectiveness of M3, compared to standard care, within a 24-month, two-arm, randomised controlled trial in 16-45 year olds with early-onset T2D.

An internal feasibility assessment, mixed methods process evaluation, and study within a trial will be embedded within the trial. An ongoing PPI/E strategy will underpin the programme, along with diverse dissemination to a variety of audiences throughout. In addition to dissemination through academic journals and conferences, people living with early-onset T2D, the NHS, and the wider public will be informed of research findings through several means.

Study summary

Study progress 

The epidemiology and evidence synthesis as part of WP1 has been completed. Findings from this work has informed the intervention design in WP2 and are currently being disseminated. The final stages of intervention development are currently underway, and it is anticipated that the randomised controlled trial will be ready to commence in early 2023. PPI/E work will be ongoing throughout the duration of the programme.

Study publications

Barker, M. M., Davies, M. J., Zaccardi, F., Brady, E. M., Hall, A. P., Henson, J., Khunti, K., Lake, A., Redman, E. L., Rowlands, A. V., Speight, J., Yates, T., Sargeant, J. A., & Hadjiconstantinou, M. (In Review). Age at diagnosis of type 2 diabetes and depressive symptoms, diabetes-specific distress and self-compassion.

Barker, M. M., Zaccardi, F., Brady, E. M., Gulsin, G. S., Hall, A. P., Henson, J. J., Htike, Z. Z., Khunti, K., McCann, G. P., Redman, E. L., Webb, D. R., Wilmot, E. G., Yates, T., Yeo, J., Davies, M. J., & Sargeant, J. A. (2022). Age at diagnosis of type 2 diabetes and cardiovascular risk factor profile: A pooled analysis. World Journal of Diabetes, 13(3), 260. https://doi.org/10.4239%2Fwjd.v13.i3.260

Sargeant, J. A., Brady, E. M., Zaccardi, F., Tippins, F., Webb, D. R., Aroda, V. R., Gregg, E. W., Khunti, K., & Davies, M. J. (2020). Adults with early-onset type 2 diabetes (aged 18–39 years) are severely underrepresented in diabetes clinical research trials. Diabetologia, 63(8), 1516–1520. https://doi.org/10.1007/s00125-020-05174-9

Data Protection

http://www.leicesterdiabetescentre.org.uk/Privacy.Policy

Principle Investigator – Professor Melanie Davies: melanie.davies@uhl-tr.nhs.uk

For specific queries and for more information about The M3 Study please contact us on the following email address: m3research@uhl-tr.nhs.uk




Navjot Kaur