taRgeting bEtA-Cell Function To achIeVe Remission of Type 2 diAbeTEs

This is a single-centre, open-label, randomised, parallel design study comparing up to 12 weeks of fully closed-loop insulin delivery to standard care with a glucose sensor in adults with recent-onset type 2 diabetes.

Recruitment will target up to 56 participants to allow for drop-outs. Participants will be recruited from outpatient clinics at Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, local GP surgeries, social media advertising or other established practices at the centre. Written informed consent will be obtained from all participants before any study related activities.

After obtaining informed consent, the baseline visit (including mixed meal tolerance test) and a 2-3 week run-in period, participants will be randomised to either 12 weeks use of fully closed-loop insulin delivery or 12 weeks during which they will apply their standard diabetes therapy with a glucose sensor. Participants in both groups will receive diet and lifestyle advice with specific focus on the impact of diet and lifestyle choices on glucose sensor readings and trends.

Following the 12 weeks intervention period (and repeat mixed meal tolerance test) all participants will continue with standard diabetes therapy for nine months of follow-up (and final mixed meal tolerance test). Diabetes therapies will be adjusted every 3 months based on HbA1c.

The study includes up to 5 visits and 6 telephone/email contacts. Visits 2 and 3 may be combined. All participants will continue to be seen by their clinical team at frequencies as appropriate in line with usual clinical practice. All study visits will be scheduled in addition to routine clinical visits and will be performed by the research team. Maximum time in the study is 56 weeks.

Inclusion criteria

• Aged 18 years and older
• Type 2 diabetes diagnosed >6 months and ≤5 years ago
• Treatment with glucose lowering medication for at least 3 months
• HbA1c >48 mmol/mol on analysis from local laboratory or equivalent
• Willing to wear study devices and follow study instructions
• Capacity to consent to participate in the study

Exclusion criteria

• Type 1 diabetes
• Current use of insulin pump
• Current use of any closed-loop system
• Any physical/psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician
• Known or suspected allergy against insulin
• Pregnancy, planned pregnancy, or breast feeding
• Severe visual or hearing impairment
• Medically documented allergy towards the adhesive of plasters
• Serious skin diseases located at places of the body potentially used for localisation of the glucose sensor
• Drug or alcohol misuse
• Group 2 driving licence holder