T1D1

The T1D1 is a mobile application for iOS and Android devices that helps people with Type 1 diabetes aged 2 and older manage their condition by calculating insulin doses based on user-entered data. A healthcare professional must first program the patient's target blood glucose values, insulin-to-carbohydrate ratios, and correction factors into the app. The app includes a bolus calculator, electronic logbook for tracking doses and glucose levels, and customizable presets to simplify daily insulin dosing.

T1D1 operates on both iOS and Android platforms and implements standard ADA insulin bolus calculations without modifications. Unlike the predicate device (InPen), T1D1 does not track residual bolus insulin or provide reports and graphs, though it does warn users about recently logged insulin doses. T1D1 is not connected to blood glucose or continuous glucose monitoring devices, requires WiFi/mobile data only for backend synchronization (not for core calculation), does not include a carbohydrate calculator, and operates independently of any other diabetes care devices.

Risk analysis per ISO 14971:2019; software development per IEC 62304; software verification and validation per FDA guidance on Device Software Functions (June 2023) using Enhanced Documentation Level; cybersecurity evaluation per FDA Cybersecurity guidance (September 2023); human factors and usability testing per FDA guidance (February 2016); and design considerations for home-use devices per FDA guidance (November 2014).

T1D1 is substantially equivalent to the InPen Dose Calculator predicate because both devices share the same regulatory classification (Class II, 21 CFR 868.1890), product code (NDC), and operational principle of calculating insulin bolus doses using standard formulas based on user-entered glucose and carbohydrate data. Both are software-based calculators for multiple daily injection therapy that do not control insulin delivery or glucose measurements. The differences—T1D1's lower age range (age 2 vs. 12), Type 1-only indication, over-the-counter use, and lack of carbohydrate calculator and residual bolus tracking—do not raise new safety or effectiveness concerns because the core insulin calculation algorithm is identical and unmodified, the warning about recent insulin administration mitigates stacking risk, and all design controls have been verified and validated.