Efficacy of an AI-Enabled Low Glucose Prediction: A Pooled Performance Analysis With Capillary Blood Glucose as Ground Truth

BACKGROUND: Hypoglycemia is a critical challenge for insulin-dependent people with diabetes using multiple daily injections (MDI), who rely on reactive responses to continuous glucose monitoring (CGM) alerts. To meet the need for a proactive safety tool, we evaluated the performance of the Low Glucose Predict (LGP) feature in the Accu-Chek SmartGuide Predict App. METHODS: This retrospective analysis pooled data from three prospective trials, including 85 subjects over 2709 recording days. The LGP feature uses a XGBoost model to predict low glucose events up to 30 minutes in advance. Performance was assessed rigorously against both capillary blood glucose (BG) and CGM values, including an analysis with "close-call" predictions (+10 mg/dL above the threshold). Metrics included sensitivity, specificity, and ROC-AUC. RESULTS: Against the stringent capillary BG reference, LGP showed high performance: sensitivity of 87.13% and specificity of 97.43% (ROC-AUC 0.9787). Including close-call events improved sensitivity to 91.89% and specificity to 98.09%. Referenced against CGM, sensitivity was 94.40% and specificity was 98.25%. The system provided an actionable mean lead time of 14.71 ± 8.30 minutes (CGM reference), with a low average daily true notification rate of 1.31 (2.60 including close-calls). CONCLUSION: The LGP feature is an accurate, highly sensitive, and specific tool for timely, proactive low glucose prediction, validated against both capillary BG and CGM. This predictive intelligence is a crucial mechanism for people with diabetes to safely mitigate hypoglycemia risk, addressing a significant clinical gap and potentially reducing fear of hypoglycemia and diabetes distress.