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

RecruitingNAAges 18 Years - anyAllUniversity of Cambridge
NCT06844539 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The main objective of the REACTIVATE study is to investigate whether a period of intensive insulin therapy using closed-loop technology, when combined with diet and lifestyle education, can restore beta-cell function and achieve remission of recent-onset 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. The primary outcome is the number of participants achieving remission of diabetes at 52 weeks, defined as HbA1c below 48mmol/mol after 12 or more weeks off all diabetes medications. Other key outcomes include area under the curve for C-peptide and glucose during mixed meal tolerance test, the proportion of time spent with glucose levels within and above the target glucose range and mean sensor glucose as

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📋 Eligibility rules (as published)
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
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What it tests

  • Fully automated insulin delivery with CamAPS HX
  • Standard diabetes therapy with a glucose sensor
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Where

1 site
Addenbrooke's Hospital NHS Foundation Trust
Cambridge, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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