Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Miss Lisa Moyes
+44 116 258 4251
lisa.moyes@uhl-tr.nhs.uk


Prof Melanie Davies
+44 116 258 6481
melanie.davies@uhl-tr.nhs.uk


Dr Jack Sargeant
+44 116 258 8624
jack.sargeant@uhl-tr.nhs.uk


Dr Tommy Slater
-
tommy.slater@leicester.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - Effectiveness of a holistic intervention to address multimorbidity in adults with early-onset type 2 diabetes
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Effectiveness of a holistic intervention to address multimorbidity in adults with early-onset type 2 diabetes

Recruiting

Open to: All Genders

Age: Adult

Leicester London Derby

Medical Conditions

Type 2 diabetes

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Type 2 diabetes is a condition where the body struggles to process blood glucose, causing a higher chance of problems like heart attacks and strokes. Type 2 diabetes is becoming more common and adults are getting it earlier (aged under 40). This ‘early-onset’ type 2 diabetes is worrying because health problems can develop faster and people can die younger. Early-onset type 2 diabetes often occurs with other health conditions, including obesity, high blood pressure and mental health problems, like anxiety or depression. The good news is that early treatment and diabetes self-management can reduce the risk of health problems developing. Currently, early-onset type 2 diabetes care is delivered in the same way as for older adults. However, attendance tends to be low, probably because younger adults have very different lives and needs. Several things may help younger people with type 2 diabetes care for their health, including making sure it:
• is holistic, meaning that it includes lots of different things which will help improve health
• is 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 type 2 diabetes. This study aims to see whether the M3 intervention can improve the health of younger people with type 2 diabetes compared to the standard care which is currently offered.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

13 Sep 2023 28 Feb 2025

Participants will be randomly allocated to one of two groups. The control group will continue to receive their standard care. The M3 intervention group will receive a multifactorial care package that is tailored specifically to the needs of young adults with type 2 diabetes. The care will be delivered over 24 months by a team of healthcare practitioners who have received bespoke training. The intervention involves several components, including person-centred care which focusses on what matters most to the participant, personalised drug reviews and the earlier use of newer therapies where appropriate, personalised strategies for dietary, psychology, and physical activity support, and the use of novel technology, including wearable devices (glucose sensors and physical activity monitors), online health monitoring reports, and an online health management system, to help facilitate a flexible approach to care and allow easier communication between the participant and the care team.

All participants will undergo a series of assessments which take place in the laboratory at the beginning of the study (baseline), at 26 weeks, 52 weeks, and 104 weeks. Participants will also have reviews every 3 months either over telephone, video call, or face-to-face (according to their preference), to monitor and discuss progress.


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 of starting the trial
• can provide informed consent

You can take part if:



You may not be able to take part if:


1. Diagnosed with other forms of diabetes (e.g., type 1 diabetes, monogenic diabetes [MODY], gestational diabetes or latent autoimmune diabetes in adults [LADA])2. Serious illness or event with life-expectancy <1 year or other significant illness which, in the opinion of a study clinician, precludes involvement3. Planned major surgery4. Requirement for renal replacement therapy5. Current pregnancy, or actively trying to conceive 6. Unable or unwilling to provide informed consent7. Current participation in a competing clinical trial (CTIMP, as determined by the study investigator)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospitals of Leicester NHS Trust
    Leicester Royal Infirmary Infirmary Square
    Leicester
    LE1 5WW
  • Imperial College Healthcare NHS Trust
    The Bays St Marys Hospital South Wharf Road
    London
    W2 1BL
  • University Hospitals of Derby and Burton NHS Foundation Trust
    Royal Derby Hospital Uttoxeter Road
    Derby
    DE22 3NE

During the study, participants will receive close monitoring of their diabetes. The study will also provide detailed results from a range of health and wellbeing assessments. The researchers will be happy to review the results with them after the study is completed. The M3 intervention could potentially benefit participants in this group in several ways, including support to do more physical activity and improve diet, earlier access to medications that may be beneficial, psychosocial support to help manage stress, anxiety, and distress, education around what causes diabetes and how to manage overall health in the long term, and care that is tailored specifically to needs and preferences.
There may be an additional time commitment for people in the M3 intervention group, as they will complete both the study assessments and some extra assessments used to personalise and tailor the treatment to their needs. The functional tests in the 52-week and 104-week visits are not strenuous, but can make some people feel uncomfortable or unsteady. A trained member of staff will always supervise the tests the participant can stop the test whenever they wish. Finally, giving blood can cause mild pain and discomfort. Trained research staff will take the blood samples and the comfort of the participant will be prioritised. Every attempt will be made to make the procedure as pain free as possible.

Prof Melanie Davies
+44 116 258 6481
melanie.davies@uhl-tr.nhs.uk


Dr Tommy Slater
-
tommy.slater@leicester.ac.uk


Miss Lisa Moyes
+44 116 258 4251
lisa.moyes@uhl-tr.nhs.uk


Dr Jack Sargeant
+44 116 258 8624
jack.sargeant@uhl-tr.nhs.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Leicester and funded by NIHR Central Commissioning Facility (CCF).




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Read full details for Trial ID: ISRCTN16890855

Or CPMS 55295

Last updated 06 February 2025

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