Using closed-loop insulin delivery to achieve remission of type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether intensive insulin therapy using closed-loop technology, combined with diet and lifestyle education, can restore beta-cell function and achieve remission in adults with recent-onset type 2 diabetes. It is a single-centre, open-label, randomised, parallel design study comparing 12 weeks of closed-loop insulin delivery to standard care with a glucose sensor. The primary outcome is the number of participants achieving diabetes remission at 52 weeks, defined as HbA1c below 48mmol/mol after 12 weeks off all diabetes medications. Participants will also undergo mixed meal tolerance tests to assess key metabolic outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Addenbrooke's Hospital NHS Foundation Trust
  Cambridge, Cambridgeshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Charlotte K Boughton — University of Cambridge
• Study coordinator: Charlotte K Boughton
• Email: cb2000@cam.ac.uk
• Phone: +44 (0)1223 769066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.