Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Felix Shirmann, Dr +44 0207 622 4777
felix.schirmann@oviva.com


Bogna Nicinska +44 0207 622 4777
bogna.nicinska@oviva.com


Study Location:

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Be Part of Research - Trial Details - SAFE-LCD Trial, for Insulin-treated Adults Living With Type 2 Diabetes

SAFE-LCD Trial, for Insulin-treated Adults Living With Type 2 Diabetes

Recruiting

Open to: ALL

Age: 18.0 - 70.0

Medical Conditions

Diabetes Mellitus
Diabetes Mellitus, Type 2


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


SAFE-LCD study is a randomised controlled trial aiming to develop and evaluate a safe, cost-effective, easily accessible, digital Low-Calorie Diet (LCD) programme for insulin-treated adults with Type 2 diabetes (T2D), a world-first innovation.

The study plans to enrol 72 participants who will be randomly allocated to either receive the intervention or will be provided with weight loss advice suitable for insulin-treated patients through accessing the NHS 12-week weight loss plan. The intervention arm will follow Oviva Diabetes Remission Insulin (ODR-I) programme which includes expert dietitian coaching, support of a Diabetes Nurse, the Oviva app (with a 12-month weight prediction chart), a Capilar Blood Glucose (CBG) meters (for enhanced safety in view of concerns re hypo- and hyper-glycaemia), and BodyTrace weight scales.

If successful, this project will provide game-changing evidence for the support of insulin-treated T2D patients and for NHS commissioning of the digital Low-Calorie programme driving patient benefits and cost-savings.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jan 2024 Sep 2026

INTERVENTIONAL

Intervention Type : OTHER
Intervention Description : Total diet replacement for insulin-treated patients

Intervention Arm Group : Intervention (Oviva ODR-I programme);

Intervention Type : OTHER
Intervention Description : NHS 12 week weight loss programme

Intervention Arm Group : Control (NHS 12 weeks programme);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Hull University Teaching Hospital NHS Trust
    Hull
    HU3 2JZ


The study is sponsored by Oviva UK Ltd and is in collaboration with Hull University Teaching Hospitals NHS Trust; University College, London.





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Read full details for Trial ID: NCT06119204
Last updated 18 March 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.