Important patient information

Indications for use:

AspyreRx™ is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. AspyreRx provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care.

Notes regarding indications for use:

  • The device is not intended for use as a stand-alone therapy.

  • The device is not a substitute for a patient’s prescribed therapy or medication.

  • The benefit of treatment with the device was not evaluated beyond 180 days of treatment. The ability of the device to prevent potential relapse into prior behaviors after treatment discontinuation has not been studied.

  • The benefit of the device without the use of study-related compensation for glycemic monitoring has not been evaluated.

  • The device should not be used by people with unstable psychiatric disorders.

  • The device should not be used by people with severe psychiatric disorders and is not intended for use as a treatment for any psychiatric disorder or symptom.

Important Patient Information

Your healthcare provider will determine  whether AspyreRx™ is right for you. Important considerations include:
Safety

  • AspyreRx is not meant to be used as a treatment without being under the care of a licensed  healthcare provider.

  • AspyreRx is meant to be used along with  your prescribed medications. You should continue  to take your medications as directed by your  healthcare provider.

  • AspyreRx has not been evaluated in patients  currently taking prandial insulin (otherwise known as meal-time or short-acting insulin) and does not offer insulin titration.

  • AspyreRx has not been evaluated in patients with HbA1c levels >11%.

  • AspyreRx has not been evaluated in patients who have undergone prior bariatric surgery.

  • AspyreRx has not been evaluated in patients with advanced heart failure.

  • AspyreRx has not been evaluated in patients who are pregnant or planning to become pregnant.

  • AspyreRx is not intended for real-time monitoring of patient biometrics such as real-time blood  glucose levels.

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