taRgeting bEtA-Cell Function To achIeVe Remission of Type 2 diAbeTEs
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Cambridge
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Fully automated insulin delivery with CamAPS HX
DeviceFully automated insulin delivery with CamAPS HX app, Libre 3 glucose sensor and Ypsopump insulin pump.
Standard diabetes therapy with a glucose sensor
DeviceStandard diabetes therapy with a Freestyle Libre 3 glucose sensor
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Fully automated insulin deliveryExperimental treatment 1 intervention
Group B: Standard therapy with a glucose sensorActive comparator 1 intervention
Trial outcomes
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.
Time frame
52 weeksSecondary outcomes
1
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Time frame
12 weeks2
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Time frame
52 weeks3
Mixed meal tolerance test (MMTT) area under the curve for glucose
Mixed meal tolerance test (MMTT) area under the curve for glucose
Time frame
12 weeks4
Mixed meal tolerance test (MMTT) area under the curve for glucose
Mixed meal tolerance test (MMTT) area under the curve for glucose
Time frame
52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cambridge
Lead sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov