Actively Recruiting
taRgeting bEtA-Cell Function To achIeVe Remission of Type 2 diAbeTEs
Led by University of Cambridge · Updated on 2025-03-28
56
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
U
University of Cambridge
Lead Sponsor
C
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
taRgeting bEtA-Cell Function To achIeVe Remission of Type 2 diAbeTEs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Addenbrooke's Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
Research Team
C
Charlotte K Boughton
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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