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.