NHS FIT
Research type
Research Study
Full title
Exploring the feasibility of an immunotherapy infusion service for type 1 diabetes prevention in the UK NHS setting.
IRAS ID
354294
Contact name
Renuka Dias
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
This research aims to study how a new treatment called teplizumab can be effectively delivered within the NHS to prevent type 1 diabetes. Teplizumab is an immunotherapy drug that can delay the onset of type 1 diabetes in high-risk individuals by about 32 months on average. It requires 14 consecutive days of infusions, making its delivery potentially challenging within busy NHS services.
The study will explore both the practical aspects of delivering this treatment and how acceptable it is to patients and families. It will do this by interviewing up to 30 patients or families who have received or been offered the treatment, and surveying healthcare staff at approximately 15 hospitals across England, Scotland, Wales and Northern Ireland.
The researchers want to understand whether a combined approach - where patients receive their first five days of treatment in hospital followed by nine days at home with a visiting nurse - could work well in the NHS. This approach is currently used successfully in France. The study will examine the challenges and benefits of this model, considering factors like geographical access, staffing needs, and patient preferences.
For younger patients (aged 8-15), the researchers will use child-friendly methods including asking children to draw pictures about their experiences. All participants will be interviewed 3-6 weeks after completing their treatment to understand their views on how it was delivered.
The findings will help develop recommendations for implementing teplizumab treatment across the NHS in a way that works well for both healthcare services and patients. This is particularly timely as teplizumab is currently being reviewed by NICE and may soon become more widely available in the UK. The study will ensure the NHS is well-prepared to deliver this promising new treatment effectively and equitably.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
25/ES/0041
Date of REC Opinion
21 May 2025
REC opinion
Favourable Opinion