Randomised Controlled Multicentre Trial to Investigate the Effectiveness of a Mobile Artificial Intelligence Solution...

Achieving optimal glycaemic control remains a burden for many people with diabetes on intensive insulin treatment. The MELISSA trial aims to clinically validate the artificial intelligence (AI)-based MELISSA system to support people with Type 1 diabetes on multiple daily insulin injections (MDI) with personalised insulin dose recommendations and an innovative approach for automatic carbohydrate estimation. In addition, feasibility will be explored in people with Type 2 diabetes.

The MELISSA trial is a 22-week European multicentre, prospective randomised open-label blinded endpoint trial including people with Type 1 (n = 278) and an exploratory cohort of people with Type 2 diabetes (n = 50) on MDI. The MELISSA system consists of two AI-driven features: an adaptive basal-bolus advisor (ABBA), which can be supported by an automated dietary assessment system, goFOOD^TM. ABBA provides personalised suggestions for basal insulin and mealtime insulin doses, while goFOOD^TM converts food images into carbohydrate content estimations. After the initialisation period (Weeks 0-6), participants will be randomised 1:1 to either the MELISSA system or the continuation of usual care.

The primary endpoint is the between-group change in percentage of time spent in the target range (3.9-10.0 mmol/L [70-180 mg/dL]) from baseline to study end. Secondary outcomes include additional glycaemic metrics, patient-reported-outcomes, and safety information. The trial was approved by the Sponsor's Medical Ethics Research Committee (NL-009099).

The MELISSA system will potentially improve glycaemic control and quality of life in people with Type 1 diabetes on MDI. The trial outcomes will provide necessary input for obtaining Conformité Européenne certification (class IIb) for the MELISSA system.