INDICATIONS FOR USE
The twiist system is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages six and above. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The twiist system is intended for single patient, home use and requires a prescription.

The twiist Loop algorithm is intended for use with compatible integrated continuous glucose monitors (iCGM) and the twiist alternate controller enabled (ACE) insulin infusion pump 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. The twiist Loop algorithm is intended for the management of type 1 diabetes mellitus in persons six years of age and greater. The twiist Loop algorithm is intended for single-patient use and requires a prescription.

The twiist Automated Insulin Delivery System includes a simple bolus calculator available when Loop is off. It is indicated for use for aiding the user in determining the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator entered blood glucose, insulin sensitivity, insulin to carbohydrate ratio, target glucose values, and current insulin on board.