The DR-EAM Type 2 Diabetes Study

Type 2 Diabetes Clinical Trial

Official title: The 'DR-EAM' Study - (Type 2) Diabetes Weight Reduction - Evaluation of Appcoaching Model

Status Active, not recruiting

Clinical Trial Summary

The goal of this 12-month interventional study is to analyse the clinical outcome benefits, scalability and cost-effectiveness of a digital Low-Calorie digital Type 2 diabetes mellitus (T2DM) remission program compared to usual National Health System (NHS) care.

Clinical Trial Description

Low-Calorie Diets (LCD) have recently gained popularity as a means of achieving an average 10kg weight loss, 10mmol/mol HbA1c reductions, 50% medication reductions, and Type 2 diabetes mellitus (T2DM) remission (defined as blood-glucose levels <48mmol/mol and off all diabetes-related medications). If these clinical outcomes could be achieved at scale in the United Kingdom, the potential savings for the National Health System (NHS) from reductions in T2DM complications and medication costs are very significant. However, face-to-face T2DM LCD programs are hard to scale due to challenges of accessibility, capacity, and cost.

This single-arm real-world evaluation with a matched control group from comparable GP practices will evaluate clinical outcome benefits and NHS return on investment of a digital LCD program with integrated behavior change intervention.

The 197 will be recruited from GP practices across South West London and Buckinghamshire. Participants will complete a 12-week Total Diet Replacement (TDR) which involves a low-calorie (800kcal/day), nutritionally complete diet, followed by a 4-week food-based reintroduction period; and weight loss maintenance support monthly to 12 months. If a participant gains more than 2kg in the maintenance phase, they have the option to follow a TDR for an additional 4 weeks.

The intervention will be led by Diabetes Specialist Dietitians (DSD) via the Oviva app, telephone, or video calls. All participants will have access to supporting learning materials. Participants will receive intensive support in the first 16 weeks; follow-up support for a further 36 weeks, plus a further 12 months of 'Active follow-up'. Participants finish the trial at 24 months.

After completion, participants continue to receive free access to the Oviva app and their connected monitoring devices. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT05626842
• Study type: Interventional
• Source: Oviva UK Ltd
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 20, 2021
• Completion date: September 30, 2023