SAFE-LCD
Research type
Research Study
Full title
A randomised controlled trial to determine safety and efficacy of a digital low-calorie diet programme (SAFE-LCD) for insulin-treated adults living with type 2 diabetes
IRAS ID
321277
Contact name
Felix Schirmann
Contact email
Sponsor organisation
Oviva UK Ltd
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
SAFE-LCD study is a randomised controlled trial which aims to develop and evaluate a safe, efficacious, cost-effective, easily accessible, digital Low-Calorie Diet (LCD) programme for insulin-treated adults with Type 2 diabetes (T2D). Insulin treatment in Type 2 diabetes (T2D) patients is linked to poorer quality of life and an increased risk of complications due to disease progression. 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 will involve a 12-week Total Diet Replacement (TDR) diet of approximately 850 calories per day through four TDR products daily, followed by a 6-week food reintroduction period; and weight maintenance support for 8 months. Care will be delivered fully remotely by Oviva’s Diabetes Specialist Dietitians. The aim of treatment is to achieve weight loss, improve diabetes control quality of life and decrease or in some cases discontinue insulin treatment. Evidencing that care is effective when delivered digitally will potentially reduce the cost of future programmes and remove many barriers to access, allowing services to be available to more people on insulin.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
23/YH/0238
Date of REC Opinion
8 Nov 2023
REC opinion
Further Information Favourable Opinion