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Introduction People with type 2 diabetes can experience diabetes distress which can negatively affect health outcomes. Non-pharmacological interventions such as mindfulness can help address diabetes distress. However, face-to-face programmes can be constrained by cost, poor accessibility and lack of availability. Mobile apps for mindfulness may overcome these issues but evidence of their effectiveness is limited, and some have poor interface design with basic visualisations and feedback.Methods and analysis Our study will explore using virtual reality (VR) as an immersive and interactive technology that could support mindfulness practice to help reduce diabetes distress. We will use a mixed-methods design to pilot a new co-design process called Artificial Intelligence-informed Experience-Based Co-Design. Phase 1 will identify and evaluate existing VR mindfulness apps, followed by interviews with mindfulness experts to gain their perspectives on practising mindfulness in virtual settings. This will be followed by a participatory design phase with a series of five co-design workshops where adults with type 2 diabetes will (1) discuss diabetes distress and learn about mindfulness, (2) evaluate commercially available VR mindfulness apps, (3) employ artistic methods to produce a personalised mindfulness experience, (4) create digital content for a virtual mindfulness experience via generative artificial intelligence tools and (5) prioritise key design features, functionality and content for a tailored VR mindfulness app. The final phase will focus on developing a bespoke VR mindfulness app and evaluating it with adults with type 2 diabetes using interviews, questionnaires and VR app analytics to determine if the new digital mental health intervention can help reduce diabetes distress and improve quality of life.Ethics and dissemination We received ethical approval from The University of Manchester (2024-18262-32710 and 2024-21170-37093). Written informed consent will be obtained from all participants. Dissemination will include scientific publications and presentations, social media, knowledge translation events and educational resources for teaching students.

Introduction The prevalence of gestational diabetes mellitus (GDM) is rising in the UK and is associated with maternal and neonatal complications. National Institute for Health and Care Excellence guidance advises first-line management with healthy eating and physical activity which is only moderately effective for achieving glycaemic targets. Approximately 30% of women require medication with metformin and/or insulin. There is currently no strong evidence base for any particular dietary regimen to improve outcomes in GDM. Intermittent low-energy diets (ILEDs) are associated with improved glycaemic control and reduced insulin resistance in type 2 diabetes and could be a viable option in the management of GDM. This study aims to test the safety, feasibility and acceptability of an ILED intervention among women with GDM compared with best National Health Service (NHS) care.Method and analysis We aim to recruit 48 women with GDM diagnosed between 24 and 30 weeks gestation from antenatal clinics at Wythenshawe and St Mary’s hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000 kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial and adherence to both dietary interventions. Safety outcomes will include birth weight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0 mmol/L). Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals’ experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.Ethics and dissemination Ethical approval has been granted by the Cambridge East Research Ethics Committee (22/EE/0119). Findings will be disseminated via publication in peer-reviewed journals, conference presentations and shared with diabetes charitable bodies and organisations in the UK, such as Diabetes UK and the Association of British Clinical Diabetologists.Trial registration number NCT05344066.

Introduction Rising levels of overweight and obesity among people with type 1 diabetes (T1D) contribute to insulin resistance, dyslipidaemia, retinopathy, cardiometabolic complications and psychological morbidity. Continuous low-energy diets (CLED) providing approximately 800 kcal (3347 kJ)/day can produce significant weight loss in type 2 diabetes, and intermittent low-energy diets (ILED) may be an alternative. The Manchester Intermittent and Daily diet Type 1 Diabetes App Study (MIDDAS-Type 1) aims to assess the safety, acceptability and feasibility of remotely delivered ILED and CLED programmes for people with T1D and overweight and obesity.Methods and analysis Twelve participants with T1D and body mass index ≥27.5 kg/m2 (≥25 kg/m2 in high-risk ethnic minorities) recruited from an National Health Service (NHS) trust and research register in England will be randomised to a remotely delivered CLED (n=6) or ILED (n=6) for 12 weeks. The CLED includes a daily Optifast 850 kcal (3556 kJ) 75 g carbohydrate formula diet. The ILED includes 2 days/week of Optifast and 5 days of a portion-controlled Mediterranean diet (170–250 g carbohydrate/day). Both groups will receive matched high-frequency remote support from a dietitian, nurse and psychologist via telephone and/or the Oviva app. The primary outcome will assess safety (occurrence of severe hypoglycaemia, ketonaemia, ketoacidosis and time above and below target blood glucose). Secondary outcomes include study uptake, retention, dietary adherence, acceptability, intervention delivery fidelity and potential efficacy in relation to change in weight, insulin requirements, glycated haemoglobin, lipids, insulin resistance (estimated glucose disposal rate) and quality of life. Participants will be invited for optional repeat measurements at 52 weeks.Ethics and dissemination The trial protocol (V4.0/08.06.2022) was granted ethical approval by Cambridge East Research Ethics Committee (Ref: 21/EE/0014). The study will inform progression to a full-scale randomised controlled trial to test the efficacy of these programmes for patients with T1D and overweight and obesity.Trial registration number NCT04674384; Pre-results.