REACTIVATE v1.0 (CPMS: 56172, IRAS 346139)

UPDATED - 07/08/2025

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 study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 2 diabetes.

The study consists of two phases. Phase 1 will assess residual beta cell function across various diabetes stages using a mixed meal tolerance test.

Phase 2 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 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. 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 (3.9 to 10.0mmol/L) 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 & closed-loop usage, questionnaires and semi-structured interviews.

***GP practices will only be identifying participants for phase 2.***

INCLUSION CRITERIA:

Phase 2 - Inclusion criteria:

 1. Aged 18 years and older.

 2. Type 2 diabetes diagnosed > 6 months and < = 5 years ago. 

3. Treatment with glucose lowering medication for at least 3 months.

 4. HbA1c > 48 mmol/mol on analysis from local laboratory or equivalent .

5. Willing to wear study devices and follow study instructions. 

6. Capacity to consent to participate in the study.

EXCLUSION CRITERIA:

Phase 2 - Exclusion criteria:

1. Type 1 diabetes .

2. Current use of insulin pump.

3. Current use of any closed-loop system.

4. 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.

 5. Known or suspected allergy against insulin 6. Medically documented allergy towards the adhesive.

 7. Pregnancy, planned pregnancy, or breast feeding.

8. Severe visual or hearing impairment.

9. Medically documented allergy towards the adhesive of plasters.

10. Serious skin diseases located at places of the body potentially used for localisation of the glucose sensor.

11. Drug or alcohol misuse.

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

EMIS: Jodie Button – jodie.button@nihr.ac.uk 

SystmOne: James Baslington – james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

While we endeavour to keep the information, tools and resources provided up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the tools provided for any purpose. Any reliance you place on such information is therefore strictly at your own risk.

In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of the tools provided.