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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Addenbrooke's Hospital NHS Foundation Trust
RECRUITING
Cambridge
Contact Information
Primary
Charlotte K Boughton
cb2000@cam.ac.uk
+44 (0)1223 769066
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 56
Treatments
Experimental: Fully automated insulin delivery
Fully automated insulin delivery with CamAPS HX, Freestyle Libre 3 Sensor and Ypsopump insulin pump for 12 weeks
Active_comparator: Standard therapy with a glucose sensor
Standard diabetes therapy with a glucose sensor for 12 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Cambridge University Hospitals NHS Foundation Trust
Leads: University of Cambridge

This content was sourced from clinicaltrials.gov