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taRgeting bEtA-Cell Function To achIeVe Remission of Type 2 diAbeTEs

NCT06844539 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Fully automated insulin delivery with CamAPS HX

Fully automated insulin delivery with CamAPS HX app, Libre 3 glucose sensor and Ypsopump insulin pump.

DEVICE

Standard diabetes therapy with a glucose sensor

Standard diabetes therapy with a Freestyle Libre 3 glucose sensor

Sponsors & Collaborators

Principal Investigators

  • Charlotte K Boughton · University of Cambridge

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-24
Primary Completion
2028-12-31
Completion
2029-04-30

Countries

  • United Kingdom

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06844539 on ClinicalTrials.gov