The Smart MDI System in People With Type 1 Diabetes and High HBA1C: A Randomized Controlled Trial Demonstrating That Response to Alerts Drives Outcomes.

AIMS: The aim was to assess the efficacy and safety of the smart multiple daily injections (MDI) system versus MDI plus continuous glucose monitor (CGM) in people with Type 1 diabetes and HbA1c ≥ 8%.

MATERIAL AND

METHODS

After a 3-week run-in, 143 participants were randomized to Smart MDI or MDI + CGM. The primary endpoint was between-group difference (Δ) in time-in-range (TIR) at 6 months, adjusted for baseline glycaemia and assessed for non-inferiority (margin 7.5%). Secondary endpoints included HbA1c (non-inferiority margin 0.4%) and superiority analyses for TIR and HbA1c. Smart MDI alerts prompt insulin bolus actions (in contrast to traditional CGM alerts), and post hoc analyses were performed to evaluate 'alert-responsiveness' on glycaemia. Alert-responsiveness findings were validated in a real-world cohort of 5507 users. Safety endpoints were assessed.

RESULTS

At 6 months, Δ TIR between groups was 0.19 percentage points (95% confidence interval: -4.9 to 5.3), thus meeting non-inferiority; HbA1c also met non-inferiority (Δ: -0.13 percentage points, -0.46 to 0.19) but neither showed superiority. Post hoc analyses showed higher responders to alerts (those responding more than the median response rate of 28.3%, n = 31) had greater TIR gains than lower responders (n = 28) (+8.12 percentage points; p = 0.04) and HbA1c reduction (-0.6 percentage points; p = 0.02). TIR benefits in higher responders were confirmed in the real-world cohort. One episode of diabetic ketoacidosis occurred (run-in) and one severe hypoglycaemic event occurred (control arm).

CONCLUSIONS

Smart MDI is safe and non-inferior, achieving non-inferiority to MDI + CGM regarding TIR and HbA1c. Responding to as few as 28% of alerts resulted in glycaemic improvements.