CompletedInterventional

Effectiveness of a holistic intervention to address multimorbidity in adults with early-onset type 2 diabetes

Type 2 diabetes is becoming more common in younger adults. Developing it at an earlier age increases the risk of complications like heart attacks, high blood pressure, and mental health struggles. Traditional diabetes services are often built around the needs of older people and may not fit the busy lives of younger adults. This study, run by the University of Leicester, looks at a new approach called the 'M3' care package. It provides care tailored around your personal routine. Participants are randomly chosen to receive either standard NHS care or the M3 programme for two years. Those on M3 get personal reviews of their medicines, lifestyle and emotional support, and wearable devices such as continuous glucose monitors. The trial aims to discover if this joined-up, flexible support helps people manage their condition better and live healthier lives.

At a glance

Status

Completed

Sponsor

University of Leicester

Enrolment target

246

Start

13 Sep 2023

Estimated completion

28 Feb 2025

Type 2 diabetes

What is this study about?

Type 2 diabetes happens when your body cannot properly control the amount of sugar in your blood. In the past, it mainly affected older adults, but more people are now being diagnosed under the age of 40. Getting diabetes early in life can be challenging. Health complications can develop sooner, and many younger people also face other difficulties at the same time, such as high blood pressure, weight concerns, or feelings of anxiety and low mood.

At the moment, younger adults usually receive the exact same care as older people. However, work, family commitments, and busy schedules can make it hard to attend standard daytime clinic appointments. Because of this, many younger people miss out on the regular help they need to keep their health on track. Finding care that fits around a modern lifestyle is vital to preventing long-term problems.

The M3 study aims to change this. Researchers have created a modern, whole-person care programme designed specifically for younger adults. It focuses on what matters most to each person, using flexible contact options and helpful technology like glucose sensors and activity trackers. By comparing this new programme with standard NHS care over two years, the team hopes to find a better way to support younger people with diabetes.

Key takeaways

Tests a tailored care plan designed specifically for people diagnosed with type 2 diabetes under 40.
Open to adults aged 16 to 45 with an HbA1c level of 6.0% (42 mmol/mol) or higher.
Participants are randomly assigned to receive either standard NHS care or the new M3 programme for two years.
The M3 programme includes wearable health technology, medication checks, and personal lifestyle support.
Includes convenient check-ups every three months by phone, video, or in person.
You can withdraw from the study at any time without losing any of your normal medical care.

Who may be eligible?

You may be able to join this study if you are between 16 and 45 years old and were diagnosed with type 2 diabetes before you turned 40. Your recent blood sugar check (an HbA1c test) must show a level of 6.0% (42 mmol/mol) or higher within the last three months, and you must be able to give your consent to take part.

You will not be eligible if you have a different kind of diabetes, such as type 1 diabetes, pregnancy-related (gestational) diabetes, or rare genetic forms. The study is also not suitable for people receiving dialysis or other kidney replacement therapy, those with severe illnesses, or anyone planning major surgery in the near future.

In addition, women who are currently pregnant or actively trying for a baby cannot take part. If you are already taking part in another clinical trial testing a new medicine, you will also be unable to join this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am between 16 and 45 years old.
I was diagnosed with type 2 diabetes before my 40th birthday.
My recent HbA1c test result was 6.0% (42 mmol/mol) or higher.
I am not pregnant and not planning to become pregnant during the study.
I do not have type 1 diabetes or kidney failure requiring dialysis.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for two years (104 weeks). When you join, a computer will place you at random into one of two groups. One group continues with standard NHS diabetes care. The other group receives the M3 care package, which offers extra support from specially trained healthcare staff. This package includes personalised advice on food, exercise, and emotional wellbeing, as well as reviews of your medications to see if newer treatments could help you.

If you are in the M3 group, you will also receive wearable devices, such as a glucose sensor and an activity monitor, to track your progress at home. All participants, regardless of group, attend laboratory visits at the start, at 26 weeks, 52 weeks, and 104 weeks. You will also have check-ins every three months. To make these as convenient as possible, they can take place over the phone, on a video call, or in person, depending on what you prefer.

Potential risks and benefits

Taking part means your diabetes and general health will be monitored closely, and you will receive detailed health reports that you can discuss with the study team. If you are in the M3 group, you may benefit from personalised lifestyle advice, earlier access to newer diabetes medicines, and emotional support. However, taking part does require a commitment of your time. You will need to give blood samples, which can cause brief stinging, mild bruising, or slight discomfort. Some functional tests at your annual visits might make you feel momentarily unsteady or tired, but trained staff will always supervise you and you can stop whenever you wish. You are free to leave the study at any time without your regular NHS medical care being affected.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals of Leicester NHS Trust
City only
Leicester, England
University Hospitals of Derby and Burton NHS Foundation Trust
City only
Derby, England
Imperial College Healthcare NHS Trust
City only
London, England

Common questions

What is the M3 intervention?

It is a personalised care programme designed for younger adults. It combines lifestyle support, mental wellbeing advice, medication reviews, and wearable gadgets like glucose sensors.

Can I choose which group I am in?

No. A computer places participants into either the standard care group or the M3 group by chance. This ensures the study results are fair and reliable.

Will my regular diabetes treatment stop?

No. Everyone in the study continues to receive care for their diabetes. The trial simply compares standard NHS care with an enhanced, tailored programme.

How long does the study last?

The study runs for 24 months (two years), with progress checks every three months and main health visits at the start, 6 months, 1 year, and 2 years.

What happens if I want to leave the study?

You can leave the study at any point without giving a reason. Your standard NHS care and your relationship with your doctors will not be affected in any way.

How to find out more

Lisa Moyes

lisa.moyes4@nhs.net +44 116 258 4251 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.