Type 2 DiabetesREACTIVATENCT06844539
taRgeting bEtA-Cell Function To achIeVe Remission of Type 2 diAbeTEs
A study testing Fully automated insulin delivery with CamAPS HX and Standard diabetes therapy with a glucose sensor in people with Type 2 Diabetes, run by University of Cambridge at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Fully automated insulin delivery with CamAPS HX and Standard diabetes therapy with a glucose sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2025to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Addenbrooke's Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Charlotte Boughton, +441223769066, cb2000@cam.ac.uk
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
Recruitment will target up to 56 participants to allow for drop-outs. Participants will be recruited from outpatient clinics at Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, local GP surgeries, social media advertising or other established practices at the centre. Written informed consent will be obtained from all participants before any study related activities.
After obtaining informed consent, the baseline visit (including mixed meal tolerance test) and a 2-3 week run-in period, participants will be randomised to either 12 weeks use of fully closed-loop insulin delivery or 12 weeks during which they will apply their standard diabetes therapy with a glucose sensor. Participants in both groups will receive diet and lifestyle advice with specific focus on the impact of diet and lifestyle choices on glucose sensor readings and trends.
Following the 12 weeks intervention period (and repeat mixed meal tolerance test) all participants will continue with standard diabetes therapy for nine months of follow-up (and final mixed meal tolerance test). Diabetes therapies will be adjusted every 3 months based on HbA1c.
The study includes up to 5 visits and 6 telephone/email contacts. Visits 2 and 3 may be combined. All participants will continue to be seen by their clinical team at frequencies as appropriate in line with usual clinical practice. All study visits will be scheduled in addition to routine clinical visits and will be performed by the research team. Maximum time in the study is 56 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- Fully automated insulin delivery with CamAPS HX, Standard diabetes therapy with a glucose sensor
- Keywords
- Remission, closed-loop
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully automated insulin delivery with CamAPS HXDevice
Fully automated insulin delivery with CamAPS HX app, Libre 3 glucose sensor and Ypsopump insulin pump.
Standard diabetes therapy with a glucose sensorDevice
Standard diabetes therapy with a Freestyle Libre 3 glucose sensor
| Study group | Role | What they receive |
|---|---|---|
| Fully automated insulin delivery | Experimental | Fully automated insulin delivery with CamAPS HX, Freestyle Libre 3 Sensor and Ypsopump insulin pump for 12 weeks Receives: 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 Receives: Device: Standard diabetes therapy with a glucose sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Secondary outcomes (21)
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Measured: 12 weeks
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Measured: 52 weeks
Mixed meal tolerance test (MMTT) area under the curve for glucose
Mixed meal tolerance test (MMTT) area under the curve for glucose
Measured: 12 weeks
Mixed meal tolerance test (MMTT) area under the curve for glucose
Mixed meal tolerance test (MMTT) area under the curve for glucose
Measured: 52 weeks
Proportion of time spent in tight target glucose range (3.9 to 7.8mmol/l)
Proportion of time spent with sensor glucose in tight target glucose range (3.9 to 7.8mmol/l)
Measured: 12 weeks
Proportion of time spent in tight target glucose range (3.9 to 7.8mmol/l)
Proportion of time spent with sensor glucose in tight target glucose range (3.9 to 7.8mmol/l)
Measured: 52 weeks
Proportion of time spent in target glucose range (3.9 to 10.0mmol/l)
Proportion of time spent with sensor glucose in target glucose range (3.9 to 10.0mmol/l)
Measured: 12 weeks
Proportion of time spent intarget glucose range (3.9 to 10.0mmol/l)
Proportion of time spent with sensor glucose in target glucose range (3.9 to 10.0mmol/l)
Measured: 52 weeks
Proportion of time spent below target glucose range (<3.9mmol/l)
Proportion of time spent below target glucose range (<3.9mmol/l)
Measured: 12 weeks
Proportion of time spent below target glucose range (<3.9mmol/l)
Proportion of time spent below target glucose range (<3.9mmol/l)
Measured: 52 weeks
Proportion of time spent above target glucose range (>10.0mmol/l)
Proportion of time spent above target glucose range (>10.0mmol/l)
Measured: 12 weeks
Proportion of time spent above target glucose range (>10.0mmol/l)
Proportion of time spent above target glucose range (>10.0mmol/l)
Measured: 52 weeks
Mean sensor glucose
Mean sensor glucose (mmol/l)
Measured: 12 weeks
Mean sensor glucose
Mean sensor glucose (mmol/l)
Measured: 52 weeks
Glycated haemoglobin
HbA1c (mmol/mol)
Measured: 12 weeks
Glycated haemoglobin
HbA1c (mmol/mol)
Measured: 52 weeks
Blood pressure
Blood pressure (mmHg)
Measured: 12 weeks
Blood pressure
Blood pressure (mmHg)
Measured: 52 weeks
Body weight
Body weight (kg)
Measured: 12 weeks
Body weight
Body weight (kg)
Measured: 52 weeks
Number of diabetes medications
Number of diabetes medications
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start24 Apr 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Charlotte Boughton, University of Cambridge
- Investigators
- Charlotte K Boughton, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844539
- Sponsor's protocol ID
- REACTIVATE 346139
- Acronym
- REACTIVATE
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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. To gain access, data requestors will need to sign a data access agreement. Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06844539
- Acronym / sponsor ID
- REACTIVATE / REACTIVATE 346139
- Conditions
- Type 2 Diabetes
- Keywords
- Remission, closed-loop
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- 24 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Recruitment will target up to 56 participants to allow for drop-outs. Participants will be recruited from outpatient clinics at Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, local GP surgeries, social media advertising or other established practices at the centre. Written informed consent will be obtained from all participants before any study related activities.
After obtaining informed consent, the baseline visit (including mixed meal tolerance test) and a 2-3 week run-in period, participants will be randomised to either 12 weeks use of fully closed-loop insulin delivery or 12 weeks during which they will apply their standard diabetes therapy with a glucose sensor. Participants in both groups will receive diet and lifestyle advice with specific focus on the impact of diet and lifestyle choices on glucose sensor readings and trends.
Following the 12 weeks intervention period (and repeat mixed meal tolerance test) all participants will continue with standard diabetes therapy for nine months of follow-up (and final mixed meal tolerance test). Diabetes therapies will be adjusted every 3 months based on HbA1c.
The study includes up to 5 visits and 6 telephone/email contacts. Visits 2 and 3 may be combined. All participants will continue to be seen by their clinical team at frequencies as appropriate in line with usual clinical practice. All study visits will be scheduled in addition to routine clinical visits and will be performed by the research team. Maximum time in the study is 56 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fully automated insulin delivery | Experimental | Device: Fully automated insulin delivery with CamAPS HXFully automated insulin delivery with CamAPS HX, Freestyle Libre 3 Sensor and Ypsopump insulin pump for 12 weeks |
| Standard therapy with a glucose sensor | Active comparator | Device: Standard diabetes therapy with a glucose sensorStandard diabetes therapy with a glucose sensor for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fully automated insulin delivery with CamAPS HXFully automated insulin delivery with CamAPS HX app, Libre 3 glucose sensor and Ypsopump insulin pump. | Device | Fully automated insulin delivery |
| Standard diabetes therapy with a glucose sensorStandard diabetes therapy with a Freestyle Libre 3 glucose sensor | Device | Standard therapy with a glucose sensor |
Primary outcome
The number of participants achieving remission of diabetes at 52 weeks
Time frame: 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.
21 secondary outcomes
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Time frame: 12 weeks
Mixed meal tolerance test (MMTT) area under the curve for C-peptide
Time frame: 52 weeks
Mixed meal tolerance test (MMTT) area under the curve for glucose
Time frame: 12 weeks
Mixed meal tolerance test (MMTT) area under the curve for glucose
Time frame: 52 weeks
Proportion of time spent in tight target glucose range (3.9 to 7.8mmol/l)
Time frame: 12 weeks
Proportion of time spent in tight target glucose range (3.9 to 7.8mmol/l)
Time frame: 52 weeks
Proportion of time spent in target glucose range (3.9 to 10.0mmol/l)
Time frame: 12 weeks
Proportion of time spent intarget glucose range (3.9 to 10.0mmol/l)
Time frame: 52 weeks
Proportion of time spent below target glucose range (<3.9mmol/l)
Time frame: 12 weeks
Proportion of time spent below target glucose range (<3.9mmol/l)
Time frame: 52 weeks
Proportion of time spent above target glucose range (>10.0mmol/l)
Time frame: 12 weeks
Proportion of time spent above target glucose range (>10.0mmol/l)
Time frame: 52 weeks
Mean sensor glucose
Time frame: 12 weeks
Mean sensor glucose
Time frame: 52 weeks
Glycated haemoglobin
Time frame: 12 weeks
Glycated haemoglobin
Time frame: 52 weeks
Blood pressure
Time frame: 12 weeks
Blood pressure
Time frame: 52 weeks
Body weight
Time frame: 12 weeks
Body weight
Time frame: 52 weeks
Number of diabetes medications
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: Yes. 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. To gain access, data requestors will need to sign a data access agreement. Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte K Boughton principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully automated insulin delivery with CamAPS HX and Standard diabetes therapy with a glucose sensor in people with Type 2 Diabetes, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte K Boughton (+44 (0)1223 769066, cb2000@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants achieving remission of diabetes at 52 weeks (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.