The company has begun taking orders and shipping to eligible customers in
Tandem Mobi is a new way for people living with diabetes to experience the life-changing benefits of Control-IQ technology, the same technology that helped make Tandem the #1 recommended pump brand.1 The Control-IQ advanced hybrid closed-loop automated insulin delivery feature, cleared for use by people with type 1 diabetes age 6 and up, predicts and helps prevent high and low blood sugar, and has demonstrated improved time in range throughout the day and night in numerous controlled clinical trials and real-world studies.2-4
'This tiny, wearable pump exceeded the expectations of users from an early access program, and we are thrilled to begin offering this exciting new technology to more people in the diabetes community,' said
Key Tandem Mobi System Features
Impressively Small - Less than half the size of the t:slim X2 insulin pump and small enough to fit in the coin pocket of a pair of jeans
Wearability Like Never Before - Can be worn almost anywhere, giving users greater discretion, comfort, and options for how they manage their diabetes: Wear it on-body with a lightweight adhesive sleeve (sold separately)
Clip it discreetly to clothing
Slip it into a pocket
Infusion Set Options - Compatible with all existing Tandem-branded infusion sets manufactured by
Tandem Mobi Mobile App - Full iOS mobile control through a user's compatible iPhone5
Sensor Compatibility - Compatible with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. Additional CGM sensor integrations are planned, including Dexcom G7 in the second quarter of 2024, followed by integration with the
#1 Rated1 Control-IQ Technology - Uses values from a Dexcom G6 CGM to predict glucose levels 30 minutes ahead and automatically adjust insulin, if needed, to help prevent highs and lows
Clear 200-unit cartridge - Allows users to see their remaining insulin level
Water-Resistant - The pump is water-resistant to a depth of 8 feet (2.4 meters) for up to 2 hours (IP28 rating)
Flexible Pump Control - The Tandem Mobi system has a physical button that allows users to deliver a bolus of insulin without their iPhone.
Advanced Technology - Uses modern wireless charging and is capable of remote software updates6
Accessing the Tandem Mobi System
Orders will be processed on a first come, first served basis, with initial shipments to users who meet specific eligibility requirements, including use of the Dexcom G6 CGM to access automated insulin delivery features. The Tandem Customer Care team is available now to help determine eligibility and potential timing of pump shipments for customers. People living with diabetes interested in the Tandem Mobi system can start the order process at: www.tandemdiabetes.com/mobi.
About
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. 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
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.
Forward-looking Statements
This press release contains 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements relate to, among other things, the anticipated integrations of the Tandem Mobi insulin pump with the Dexcom G7 and
Contact:
Tel: 858-366-6900
Email: media@tandemdiabetes.com
Tel: 858-366-6900
Email: IR@tandemdiabetes.com
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