NCT06844539Recruiting
taRgeting bEtA-Cell Function 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
Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 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 and closed-loop usage, questionnaires and semi-structured interviews.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 19 Feb 2025
- Start date
- 24 Apr 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Cambridge
- Diseases
- Type 2 diabetes
- NCT number
- NCT06844539
What you commit to
- Study type: Interventional
- Planned participants: 56
- From 24 Apr 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug or alcohol misuse
Other illness
- Type 1 diabetes
- 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
- Severe visual or hearing impairment
- Medically documented allergy towards the adhesive of plasters
Lab values
- Serious skin diseases located at places of the body potentially used for localisation of the glucose sensor
Other
- Current use of insulin pump
- Current use of any closed-loop system
- Pregnancy, planned pregnancy, or breast feeding
- Group 2 driving licence holder
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Addenbrooke's Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.