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

NCT06844539 | Recruiting DMC

• 1 other identifier: REACTIVATE 346139
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes

Keywords

Remission; closed-loop

Outcome Measures

Primary Outcomes (1)

• The number of participants achieving remission of diabetes at 52 weeks

  The between group difference in the number of participants achieving remission of diabetes at 52 weeks, defined as HbA1c \<48mmol/mol after ≥12 weeks off all diabetes medications.

  52 weeks

Secondary Outcomes (21)

• Mixed meal tolerance test (MMTT) area under the curve for C-peptide

  12 weeks

• Mixed meal tolerance test (MMTT) area under the curve for C-peptide

  52 weeks

• Mixed meal tolerance test (MMTT) area under the curve for glucose

  12 weeks

• Mixed meal tolerance test (MMTT) area under the curve for glucose

  52 weeks

• Proportion of time spent in tight target glucose range (3.9 to 7.8mmol/l)

  12 weeks

Study Arms (2)

Fully automated insulin delivery

EXPERIMENTAL

Fully automated insulin delivery with CamAPS HX, Freestyle Libre 3 Sensor and Ypsopump insulin pump for 12 weeks

Device: Fully automated insulin delivery with CamAPS HX

Standard therapy with a glucose sensor

ACTIVE COMPARATOR

Standard diabetes therapy with a glucose sensor for 12 weeks

Device: Standard diabetes therapy with a glucose sensor

Interventions

Fully automated insulin delivery with CamAPS HX DEVICE

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

Fully automated insulin delivery

Standard diabetes therapy with a glucose sensor DEVICE

Standard diabetes therapy with a Freestyle Libre 3 glucose sensor

Standard therapy with a glucose sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• University of Cambridge: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Addenbrooke's Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Charlotte K Boughton

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte K Boughton

CONTACT

+44 (0)1223 769066; cb2000@cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Associate

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: March 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to cb2000@cam.ac.uk and may be submitted up to 36 months following article publication.
• Access Criteria: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to cb2000@cam.ac.uk and may be submitted up to 36 months following article publication.

Locations

GB (1)