Using closed-loop insulin delivery to achieve remission of type 2 diabetes
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
This study tests if a new insulin delivery system, along with diet and lifestyle changes, can help adults with early type 2 diabetes go into remission and stop needing diabetes medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cambridge Academic / other |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT06844539 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years and older with recent-onset type 2 diabetes diagnosed within the last 6 months to 5 years.
Not a fit: Patients with type 1 diabetes or those currently using insulin pumps or closed-loop systems will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a significant improvement in diabetes management and potentially allow some patients to achieve remission.
How similar studies have performed: Other studies have shown promise with similar closed-loop insulin delivery approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cambridge, Cambridgeshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.