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

INTERVENTION: Following the completion of their baseline assessment, the participant will be randomly allocated equally to one of two groups using a secure web‐based service. Randomisation will be stratified by trial site, sex, age (=/>25 years), and baseline HbA1c (=/>8.5% [=/>69mmol/mol]): The M3 Intervention – will be delivered by a multidisciplinary team of healthcare practitioners trained specifically by members of the central research team. The intervention will utilise a hybrid approach of digital and face‐to‐face contacts to reduce participant burden. A designated care coordinator at each site will act as a central point of contact for each participant, helping to facilitate consistent, continuous care across the multidisciplinary team. The intervention will be person centred, focusing on what matters most to the participant, which may include traditional (e.g., glucose levels and body weight) and non‐traditional risk factors (e.g., psychosocial/mental wellbeing, self‐management support, and lifestyle). Healthcare professionals will perform personalised drug reviews and may promote the earlier use of newer therapies such as glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and sodium‐glucose co‐transporter‐2 inhibitors (SGLT2is), where appropriate, alongside personalised strategies for dietary, psychological, and physical activity support. Finally, the M3 intervention will make use of novel technology, including wearable devices (glucose sensors and physical activity monitors), online health monitoring reports, and an online health management system, which will facilitate a flexible approach to care and allow easier communication between the participant and the care team. Ongoing standard care – participants will continue receiving standard care under their usual diabe CONDITION: Type 2 diabetes ; Nutritional, Metabolic, Endocrine ; Type 2 diabetes mellitus PRIMARY OUTCOME: Change in HbA1c from baseline to 52 weeks collected by venous blood sampling. SECONDARY OUTCOME: Measured at baseline, week 26, week 52, and week 104, unless specified otherwise; 1. Glycaemic level: Change in HbA1c from baseline to 26 weeks and baseline to 104 weeks collected by venous blood sampling.; 2. Multimorbidity management and burden: Treatment burden using the Multimorbidity Treatment Burden Questionnaire (MTBQ).; 3. Cardiometabolic and renal risk:; 3.1. Total cholesterol and high‐density lipoprotein collected by venous blood sampling.; 3.2. Kidney function measured using estimated glomerular filtration rate (eGFR) by venous blood sampling.; 3.3. Anthropometry and body composition (body weight, height, body mass index, lean body mass, and fat mass) measured by bioelectrical impedance.; 3.4. Systolic and diastolic blood pressure measured using an automated sphygmomanometer.; 4. Psychosocial wellbeing and self‐management support:; 4.1. Self‐compassion measured using the Self‐Compassion Scale (SCS).; 4.2. Distress measured using the Problem Areas in Diabetes (PAID) questionnaire.; 4.3. Depression measured using the Patient Health Questionnaire (PHQ‐9).; 4.4. Stigma measured using the type 2 Diabetes Stigma Assessment Scale (DSAS‐2).; 4.5. Self‐efficacy measured using the Diabetes Management Self‐Efficacy Scale (DMSES).; 5. Self‐reported quality of life:; 5.1. Health status and quality of life using the EQ‐5D‐5L questionnaire.; 5.2. Health‐related quality of life across multiple domains using the Short Form 36 Health Survey Questionnaire (SF‐36).; 6. Health service resource utilisation and work productivity:; 6.1. Healthcare service utilisation using the Modular Resource Use Measure (ModRUM).; 6.2. Work productivity using the Work Productivity and Activity Impairment (WPAI) questionnaire.; 7. Physical activity: Device‐measured daily steps using a wrist‐worn accelerometer (optional to minimise participant burden).; ; Exploratory measures:; Measured at baseline and week 26 (* selected outcomes only), week 52, and week 104; 1. Other measures related to glycaemic level; 1.1. Percentage of time spent within range (% of readings and time between 3.9–10.0 mmol/L) measured using a continuous glucose monitor (optional).; 1.2. Percentage of time spent above range (% of readings and time >10.0 mmol/L) measured using a continuous glucose monitor (optional).; 1.3. Percentage of time spent below range (% of readings and time <3.8 mmol/L) measured using a continuous glucose monitor (optional).; 1.4. Fasting plasma glucose by venous blood sampling (optional if willing to fast)*.; 1.5. Fasting plasma insulin by venous blood sampling (optional if willing to fast)*.; 1.6. Fasting circulating c‐peptide by venous blood sampling (optional if willing to fast)*.; 2. Other cardiometabolic and renal risk factors; 2.1. Low density lipoprotein by venous blood sampling*.; 2.2. Fasting triglyceride by venous blood sampling (optional if willing to fast)*.; 2.3. Circulating inflammatory profile (including c‐reactive protein) by venous blood sampling*.; 2.4. Kidney function measured using urine albumin‐to‐creatinine ratio (UACR) through urine sampling, new‐onset albuminuria, and progression of albuminuria.; 2.5. Body fat percentage measured by bioelectrical impedance*.; 3. Liver function: Liver panel enzymes by venous blood sampling*.; 4. Other lifestyle related outcomes; 4.1. Self‐reported use of glucose‐lowering therapies by medical review*.; 4.2. Self‐reported change in multimorbidity status by medical review*.; 4.3. Self‐reported sleepiness measured using the Epworth Sleepiness Scale.; 4.4. Self‐reported obstructive sleep apnoea measured using the Stop‐Bang questionnaire).; 4.5. Self‐reported habitual dietary intake measured using the UK Diabetes and Diet Questionnaire (UKDDQ).; 4.6. Habitual alcohol consumption and smoking status measured by clinical review.; 5. Other assessments of physical activity, inactivity, function, or disability risk; 5.1. Device‐measured time spent performing moderate‐to‐vigorous intensity physical activity using a wrist‐worn accelerometer (optional to minimise participant burden)*.; 5.2. Device‐measured time spent sedentary using a wrist‐worn accelerometer (optional to minimise participant burden)*.; 5.3. Device‐measured sleep quality and duration using a wrist‐worn accelerometer (optional to minimise participant burden)*.; 5.4. Physical function measured using the short physical performance battery (SPPB).; 5.5. Hand grip strength measured using handgrip dynamometry.; 5.6. Disability and life participation measured using the World Health Organisation Disability Assessment Schedule (WHODAS 2.0).; INCLUSION CRITERIA: 1. Age 16 to 45 years, inclusive 2. Type 2 diabetes diagnosed before the age of 40 years; confirmed by medical history with/without specialist investigations (e.g., antibodies) 3. HbA1c> = 6.0% (> = 42mmol/mol) within 3 months of trial enrolment 4. Able to provide informed consent