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Basal-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically suspend delivery of insulin based on iCGM readings and predicted glucose values. Basal-IQ technology is intended for the management of diabetes mellitus in persons six years of age and greater. Basal-IQ technology is intended for single patient use and requires a prescription. Basal-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin. The bolus calculator is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user entered data.

Basal-IQ technology is a Predictive Low Glucose Suspend (PLGS) algorithm for the management of diabetes mellitus and is compatible with an Alternate Controller Enabled Infusion Pump (cleared under 21 CFR 880.5730)(ACE pump). Basal-IQ technology is only compatible with the Tandem t:slim X2 insulin pump (DEN180058). The Basal-IQ software and algorithm can receive interstitial sensor glucose values from a compatible iCGM system (cleared under 21 CFR 862.1355), via Bluetooth Low Energy (BLE) communication. Compatible iCGM systems are cleared and marketed separately from the Basal-IQ algorithm and are identified in device labeling. Basal-IQ assesses glucose information provided by a paired iCGM and sends commands to a compatible ACE pump to temporarily suspend insulin delivery in cases of impending or detected low blood glucose. Every 5 minutes, the Basal-IQ feature assesses glucose information provided by the iCGM to predict whether glucose values will fall below 80 mg/dL in the next 30 minutes or detect if glucose levels are currently below 70 mg/dL. Under these conditions it will command the compatible pump to suspend insulin delivery; otherwise insulin delivery continues as normal. After insulin delivery is suspended, insulin delivery resumption is commended when the system detects glucose values begin to rise. A sustained suspension period when blood glucose is above the sensor suspend threshold is mitigated by a maximum suspend time where Basal-IQ will command resume insulin delivery after 120 minutes of suspension within a 150-minute window. The Basal-IQ technology uses CGM sensor readings to send commands to a compatible insulin pump to stop and resume insulin based on the current sensor value and a 30-minute future predicted value along with the following rules: - Insulin delivery is suspended if the current CGM sensor reading is less than 70 mg/dL 1. - 2. Insulin delivery is suspended if the glucose value is predicted to be less than 80 mg/dL in 30 minutes. - 3. Basal insulin delivery is resumed once the current CGM sensor reading increases compared to the previous reading. - 4. Basal insulin delivery will also be resumed if the 30-minute predicted CGM reading is above 80 mg/dL, even if the CGM reading has not increased compared to the previous reading. - 5. Basal insulin delivery is resumed if insulin delivery has been suspended for 2 hours in a 2.5 hour window. The software comprising the Basal-IQ algorithm also includes an insulin bolus dose calculator. This calculator is for assisting patients with Type 1 diabetes who use insulin pumps as their insulin delivery therapy. It is used to calculate insulin bolus doses of rapid acting U-100 insulin analogs (Humalog and Novolog).The bolus calculator is used with manually-inputted glucose values and pump insulin delivery data to generate bolus size recommendations.