SmartGuard technology; Predictive Low Glucose technology

SmartGuard Technology is an Advanced Hybrid Closed Loop (AHCL) algorithm that automatically adjusts basal insulin delivery and delivers correction boluses every 5 minutes based on continuous glucose monitor readings. Predictive Low Glucose Technology is a Predictive Low Glucose Management (PLGM) algorithm that automatically suspends insulin delivery when sensor glucose falls below or is predicted to fall below a threshold. Both are software-only devices embedded in compatible ACE insulin pumps for managing Type 1 diabetes in persons 7 years and older.

SmartGuard differs from Control-IQ by offering user-adjustable active insulin time (2-8 hours vs. fixed 5 hours), a higher total daily insulin dose range (8-250 units vs. 5-200 units), adjustable target setpoints (100/110/120 mg/dL plus 150 mg/dL temp target vs. fixed target ranges), and auto-correction boluses calculated every 5 minutes (vs. up to once per 60 minutes). PLGM is identical to Control-IQ's suspend function except users cannot initiate manual boluses during suspension, whereas Control-IQ allows this.

Software verification per IEC 62304 and FDA's 2023 'Content of Premarket Submissions for Device Software Functions' guidance. Human factors validation per IEC 62366-1:2015, HE75:2009, and FDA's 'Applying Human Factors and Usability Engineering to Medical Devices' (February 2016). Risk management per ISO 14971:2019. Interoperability per FDA guidance 'Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices' (September 2017). Virtual patient modeling per FDA guidance 'Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions' (November 2023).

Both subject devices have identical intended use, indications, patient population (Type 1 diabetes, ages 7+), principle of operation (algorithmic insulin adjustment via CGM feedback), and compatible host devices as Control-IQ. The minor technological differences (adjustable insulin time, different target ranges, auto-correction rate) represent expanded clinical flexibility rather than fundamental functional changes. Clinical data from 222 subjects (107 pediatric, 105 adult) demonstrated SmartGuard safely reduced HbA1c and improved time-in-range comparable to predicate performance. PLGM safety was established in prior studies of the same algorithm in MiniMed 640G and 670G systems. All iAGC special controls per 21 CFR 862.1356 were met, including cybersecurity, human factors validation, data logging, and interoperability documentation.