NCT06119204

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

Trial to Determine Safety And Efficacy of a Digital Low-Calorie Diet Programme (SAFE-LCD) for Insulin-treated Adults Living With Type 2 Diabetes

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Oviva UK Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Insulin treatment in Type 2 diabetes (T2D) patients is linked to poorer quality of life and and increased risk of complications due to disease progression. This research study will be a randomised control trial (RCT) which is the highest quality form of medical evidence. It 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), 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 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 and Diabetes Specialist Nurse. Treatment aims are to achieve weight loss, improve diabetes control quality of life and decrease or in some cases discontinue insulin treatment. The evaluation of ODR-I with independent clinical and health-economic evaluations will be undertaken by University College London and Insight Health Improvement and will be published in respected academic journals. This groundbreaking research has the potential to achieve significant reductions in insulin use and to transform the lives of tens of thousands of people living with Type 2 diabetes. It will also save the NHS millions- if it is rolled out to just 62,000 patients a year, it will save more than £229 million a year in Type 2 Diabetes management costs across medications, monitoring, and hospital and General Practitioner(GP) usage.

Conditions

• Type 2 Diabetes Treated With Insulin
• Diet Habit

Interventions

Type	Name	Description
OTHER	Oviva programme	Total diet replacement for insulin-treated patients
OTHER	Usual care	NHS 12 week weight loss programme

Timeline

• Start date: 2024-01-26
• Primary completion: 2024-09-08
• Completion: 2024-09-09
• First posted: 2023-11-07
• Last updated: 2024-10-15

Locations

1 site across 1 country: United Kingdom