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Tidepool Loop, a mobile application with algorithm technology, is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) insulin infusion pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend, and with the user's confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. Tidepool Loop is intended for the management of type 1 diabetes mellitus in persons six years of age and greater. Tidepool Loop is intended for single patient use. Tidepool Loop is Rx - For Prescription Use Only.

Tidepool Loop is a mobile application with algorithm technology that works to control an ACE (Alternate Controller Enabled) insulin pump to automatically increase, and suspend delivery of basal insulin based on readings from an iCGM (integrated continuous glucose monitor) and glucose values predicted by Tidepool Loop. Tidepool Loop can also recommend, and with the user's confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. Tidepool Loop predicts glucose levels up to 6 hours in the approximate duration of insulin action for U-100 rapid-acting insulin) based on prior iCGM readings, insulin delivery history, and user input (e.g., carbohydrate intake and exercise, and in some cases fingerstick glucose) and uses that prediction to adjust insulin delivery. Tidepool Loop can be used to adjust or suspend basal insulin delivery every 5 minutes based on actual CGM sensor and predicted glucose readings. iCGM values are automatically used by the Tidepool Loop Bolus Recommendation Tool (TLBRT) when the Tidepool Loop Algorithm technology is active, i.e. when the device is operating in closed-loop mode with an active iCGM sensor session. When closed-loop mode is off, such as when it is manually disabled or when there is no active iCGM sensor session, the Tidepool Loop Bolus Recommendation Tool (TLBRT) is disabled. The user will use Tidepool Loop's simple bolus calculator. into which iCGM values are not automatically populated into the glucose field. Users must manually enter information about carbohydrates to initiate a meal bolus. When closed-loop mode is on, recommended bolus delivery is calculated using the Tidepool Loop Bolus Recommendation Tool (TLBRT) and can be manually adjusted. The Tidepool Loop app requires that specific, initial therapy settings are established by a health care provider as part of creating the prescription order. These settings include: - Target Correction Ranges for normal operation, Pre-Meal and Workout Presets . - Carb to Insulin Ratios . - Insulin Sensitivity Factors ● - Basal Rates ● - Max Basal Rate ● - Max Bolus . Tidepool Loop uses two glucose-specific settings that may be different from the user's experience with traditional glucose monitoring or CGM therapy. These are Correction Range and Glucose Safety Limit. Correction Range is the range of glucose values that the user wants Tidepool Loop to work to bring their glucose to. Correction Range can be set as low as 87 mg/dL and as high as 180 mg/dL. Tidepool Loop will warn the user if values outside the recommended bounds of 100-115 mg/dL are selected. The user can add different Correction Ranges for different times of day. Tidepool Loop supports up to 48 Correction Range segments in a 24-hour period. Tidepool Loop allows these user-customizable target Correction Ranges: - . Normal operation - Pre-meal Preset - . Workout Preset Glucose Safety Limit (mg/dL) is a safety feature of the Tidepool Loop algorithm. If the current CGM value or any future predicted glucose value is below this safety limit. Tidepool Loop will suspend insulin delivery in an effort to prevent low glucose. The algorithm will also not recommend a bolus. Glucose Safety Limit can be set as low as 67 mg/dL. It can be set as high as 110 mg/dL or to the Correction Range minimum, whichever qlucose value is lower. Tidepool Loop will warn the user if values outside Tidepool's recommended bounds of 74 to 80 mg/dL are selected. The Glucose Safety Limit is also part of the Dosing Safety Threshold, which is part of the Tidepool Loop insulin delivery algorithm. The Dosing Safety Threshold is a period of time that has the same duration as the insulin activity duration (i.e., 6 hours). The Dosing Safety Threshold is equal to the user's Glucose Safety Limit for the first half of the insulin activity duration (i.e., 3 hours), and then increases until it is at the midpoint of the Correction Range at the end of the insulin activity duration (i.e., 6 hours). Tidepool Loop is designed to be installed on an iPhone running iOS operating systems (version 15 or higher). The Tidepool Loop application includes an optional extension for Apple Watch devices running watchOS operating system (version 6.1 or higher).