Software & AppsA con­nected system to help manage diabetes

* La administración de bolus requiere un modelo de teléfono inteligente y un sistema operativo compatibles. Para los usuarios de la bomba de insulina t:slim X2, la administración de bolus también requiere una actualización de la aplicación, una actualización remota del software de la bomba y capacitación adicional. Solo disponible para usuarios de bombas que residen en los Estados Unidos.

† Es posible que no se desarrollen futuras actualizaciones para todos o algunos productos de Tandem y que no se ofrezcan en todas partes. Además, estarían sujetas a las aprobaciones regulatorias correspondientes. Las actualizaciones de software solo están disponibles para los clientes que tienen una garantía en el momento en que actualizan la bomba. Es posible que se requiera capacitación adicional para acceder a ciertas actualizaciones de software. Pueden aplicarse cargos. Tandem podrá dejar de usar determinado software y funciones a lo largo del tiempo a su discreción.

Referencias

1. dQ&A US Diabetes Connections Patient Panel Report; Net Promoter Score; enero de 2019 a septiembre de 2023: P.49, septiembre de 2023.

Important Safety Information

RX ONLY.

Indications for Use

Tandem Mobi system: The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. 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 pump is intended for single patient, home use and requires a prescription. The pump is indicated for use in individuals 6 years of age and greater.

t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. 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 pump is intended for single patient use. The pump is indicated for use with NovoLog or Humalog U-100 insulin. The pump is indicated for use in individuals 6 years of age and greater.

Control-IQ technology: Control-IQ technology is intended for use with compatible integrated continuous glucose monitors (iCGM, sold separately) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 6 years of age and greater. Control-IQ technology is intended for single patient use. Control-IQ technology is indicated for use with NovoLog or Humalog U-100 insulin.

Warning: Control-IQ technology should not be used by anyone under the age of 6 years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.

Control-IQ technology is not indicated for use in pregnant women, people on dialysis, or critically ill patients. Do not use Control-IQ technology if using hydroxyurea. Users of a Tandem insulin pump and Control-IQ technology must use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders. The Tandem pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.