The M3 Study

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  322040

• Contact name

  Melanie Davies

• Contact email

  melanie.davies@uhl-tr.nhs.uk

• Sponsor organisation

  University of Leicester

• ISRCTN Number

  ISRCTN16890855

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  What is this research about?

  Type 2 diabetes (T2D) is becoming more common, and adults are getting it at younger ages (‘early-onset adult T2D). This is worrying because heart, kidney and other problems related to diabetes can happen earlier. Healthcare for younger people with T2D is currently based on what works for older people. Several things may help younger people with T2D care for their health including making sure it is :
  • holistic, meaning that it includes lots of different things which will help improve health
  • organised to suit the person’s life and work,
  • focuses on what is important to them,
  • uses technology where needed

  The M3 intervention will bring all of these together to create a new, individualised approach to supporting younger people with T2D. This study will see whether the M3 intervention can improve the health of younger people with T2D.

  Who can take part?

  People can take part if they:
  • are aged 16 to 45 years
  • were diagnosed with type 2 diabetes before their 40th birthday
  • have an HbA1c ≥6.0% within 3 months starting the trial
  • can provide informed consent.

  Where will this study take place and what will we do?

  This study will take place at 3-6 NHS hospitals and last 24 months.

  Participants will be randomly allocated to either the M3 intervention or their usual care. Our main assessment of interest is long-term blood sugar levels. This will be measured by taking a blood test after 12-months. We will also evaluate:
  • whether M3 is good value for money
  • the experiences of people who take part in the M3 intervention
  • the experience of health care professionals who are involved in delivering the intervention.
  • whether outcome completion via a web-based app helps people complete their assessments and remain in the study compared with face-to-face, paper based, assessment completion.

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  23/EM/0032

• Date of REC Opinion

  5 Apr 2023

• REC opinion

  Further Information Favourable Opinion