All studies
RecruitingNAINTERVENTIONAL

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

The REACTIVATE study is investigating if a new approach can help people with recently diagnosed Type 2 diabetes go into remission. Remission means your blood sugar levels stay healthy without needing diabetes medication. The study will compare using an automated insulin delivery system, almost like an artificial pancreas, alongside diet and lifestyle advice, with standard diabetes care which also uses a blood sugar sensor. Our main goal is to see if more people using the automated system can achieve diabetes remission after about a year. We'll also look at how well blood sugar is controlled and any side effects. This research could help us find better ways to manage Type 2 diabetes.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Cambridge
Enrolment target
56
Start
24 Apr 2025
Estimated completion
30 Apr 2029

What is this study about?

Type 2 diabetes is a condition where your body doesn't use insulin properly or doesn't make enough of it, leading to high blood sugar levels. When you're first diagnosed, there's often a chance to improve how your body handles sugar, sometimes even putting the condition into 'remission'. Remission means your blood sugar levels are healthy without needing to take diabetes medication.

This study, called REACTIVATE, is trying to find out if an intensive but temporary treatment can help your body get back on track. We're looking at a special automated insulin delivery system, sometimes called a 'closed-loop system'. Think of it as a smart device that constantly checks your blood sugar and automatically gives you the right amount of insulin. This is compared to standard diabetes care, where you'll still use a device to monitor your blood sugar levels.

Alongside this, everyone in the study will get advice on diet and lifestyle, which we know can make a big difference in managing diabetes. The main thing we want to discover is whether using this automated insulin system for a short time (up to 12 weeks), combined with healthy living, can help more people with new Type 2 diabetes achieve remission a year later.

Key takeaways

  • This study explores if intensive insulin therapy can lead to Type 2 diabetes remission.
  • It compares an automated insulin system to standard diabetes care.
  • Diet and lifestyle advice are part of both study groups.
  • The main goal is to see how many people achieve remission after one year.
  • Participation involves monitoring, clinic visits, and follow-up for about a year.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) and have been diagnosed with Type 2 diabetes within the last six months to five years. You should also be taking medication to help lower your blood sugar for at least three months, and your recent blood test (HbA1c) should show that your diabetes isn't perfectly controlled yet.

It's important that you're willing to wear study devices and follow instructions, and that you can understand and agree to take part. Unfortunately, if you have Type 1 diabetes, already use an insulin pump or a similar automated system, or are pregnant or planning to be, this study isn't suitable for you. We also can't include people with severe sight or hearing problems, certain skin allergies, or any other health issues that might make it unsafe or difficult to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Was your Type 2 diabetes diagnosed between 6 months and 5 years ago?
  3. Are you currently taking medication for your blood sugar?
  4. Is your HbA1c (a blood test for diabetes) currently above 48 mmol/mol?
  5. Are you willing to wear study devices like a sensor and follow instructions?
  6. Do you NOT have Type 1 diabetes or use an insulin pump already?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a clinic visit for some tests and to make sure the study is right for you. This includes a special meal test to see how your body handles sugar. After this, you'll be randomly put into one of two groups for 12 weeks. One group will use the fully automated insulin delivery system, and the other will continue with their usual diabetes treatment, but with a blood sugar sensor.

Everyone will also receive advice on healthy eating and lifestyle habits. After the 12 weeks, you'll have another meal test and then continue with your standard diabetes care for about nine months, with check-ups every three months. Your total time in the study will be about 56 weeks (just over a year). You'll have up to 5 clinic visits and 6 telephone or email contacts with the study team, all in addition to your regular doctor's appointments.

Potential risks and benefits

Taking part in this study could offer you the potential benefit of closer monitoring of your blood sugar, and if you're in the automated insulin group, a new way of managing your diabetes that might improve your blood sugar control or even lead to remission. However, like any medical study, there are potential risks. The main safety concerns we'll be watching out for are very low blood sugar levels (hypoglycaemia) and any reactions to the devices, like skin irritation from sensors. You will be closely monitored by the study team, and you are free to withdraw from the study at any time for any reason without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Addenbrooke's Hospital NHS Foundation Trust
    Verified postcode
    Cambridge, United Kingdom· Recruiting

Common questions

What is 'diabetes remission'?

Diabetes remission means your blood sugar levels are healthy for a period of time without needing any diabetes medication.

What is an automated insulin delivery system?

It's a smart device that automatically delivers insulin based on continuous blood sugar readings, helping to keep your glucose levels stable.

Who is running this study?

The study is being run at Addenbrooke's Hospital, Cambridge, by a team of medical professionals.

Will I still see my regular doctor?

Yes, you will continue to have all your usual appointments with your own healthcare team as normal. The study visits are extra.

Can I leave the study once I've started?

Yes, you are free to withdraw from the study at any time, for any reason, and it won't affect your medical care.

How to find out more

Charlotte K Boughton

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "taRgeting bEtA-Cell Function To achIeVe Remission of Type 2 …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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