Targeting beta-cell function to achieve remission of type 2 diabetes (REACTIVATE). An open-label, single-centre, randomised, parallel study to assess the efficacy, safety and utility of fully closed-loop insulin delivery in achieving remission of diabetes compared to standard therapy with a glucose sensor in adults with recent onset type 2 diabetes.
Recipient organisationNIHR Cambridge Biomedical Research Centre
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Ongoing
In plain English
AI plain-English summary
A 12-week course of automated insulin delivery could reverse early type 2 diabetes and keep it at bay for at least a year. This matters because type 2 diabetes is typically seen as a progressive, lifelong condition. Once beta cells in the pancreas stop producing enough insulin, patients usually need escalating drug doses. The REACTIVATE trial tests whether a short, intensive period of fully closed-loop insulin therapy—a system that automatically adjusts insulin delivery based on real-time glucose readings—can actually restore the pancreas's own insulin production and allow patients to stop all diabetes medications. If the approach works, it could transform the treatment pathway for people diagnosed with type 2 diabetes within the past few years. Instead of managing a chronic disease indefinitely, patients might achieve drug-free remission after a single intervention. The study also aims to identify blood-based biomarkers that predict who is most likely to benefit, enabling personalised treatment decisions. Safety monitoring will track severe hypoglycaemia and other adverse events, while interviews and questionnaires will assess how acceptable the technology is in daily life.
View original technical description
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 study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 2 diabetes. Phase 1 is a cross-sectional analysis of beta-cell function using mixed meal tolerance tests in adults from across the spectrum of type 2 diabetes. This phase aims to identify novel biomarkers of beta-cell function that have prognostic value in determining the likelihood of achieving remission and can be used to inform personalised approaches to the optimal management of recent-onset type 2 diabetes to achieve remission. Phase 2 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 between group difference in the number of participants achieving remission of diabetes at 52 weeks, defined as HbA1c = 12 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 (3.9 to 10.0mmol/L) and mean sensor glucose as recorded by glucose sensor at 52 weeks. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Utility and human factors outcomes include glucose sensor & closed-loop usage, questionnaires and semi-structured interviews.
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