Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a global insulin delivery and diabetes technology company, announced positive real-world data demonstrating immediate and sustained benefits in a diverse cohort of people using the t:slim X2™ insulin pump with Control-IQ^® technology. The data was presented at the American Diabetes Association (ADA) 82^nd Scientific Sessions in New Orleans.

“Our Control-IQ technology continues to be a great equalizer for people with insulin-intensive diabetes, as we consistently see positive clinical and quality-of-life improvement with its use, regardless of age, ethnicity, or prior therapy,” said Jordan Pinsker, MD, Vice President and Medical Director for Tandem Diabetes Care. “This evidence increases our motivation to bring new advances in technology to benefit people living with diabetes worldwide.”

Data presented at the conference comes from the Control-IQ Observational (CLIO) study, an ongoing real-world, longitudinal study of people using the t:slim X2 insulin pump with Control-IQ technology.

Summaries of ADA Scientific Sessions Presentations

Psychosocial Benefits of Using Control-IQ Technology: Long-term Outcomes from a Multi-Ethnic Adult Cohort with Type 1 Diabetes¹

Named as an ADA Presidents' Select Abstract Presentation, this analysis features patient-reported outcomes from an ethnically diverse cohort of 1,306 adults. Results demonstrated significant improvements in diabetes-specific quality of life, satisfaction with insulin delivery device, and reduction in diabetes-related burden over 12 months with Control-IQ technology. Psychosocial benefits of Control-IQ technology were experienced by all ethnic cohorts. Significantly improved quality of sleep was also noted for all participants using the system.

Evaluation of Long-Term Glycemic Outcomes by Ethnicity in Adults with Type 1 Diabetes Using Control-IQ Technology²

This study assessed relationships between ethnicity, baseline HbA1c, Glucose Management Indicator (GMI), and sensor Time in Range (TIR) (70-180mg/dL) for 1,045 adult CLIO participants (Asian, Black/African American, White, and Hispanic/Latino/Spanish). GMI at study end reflected glycemic improvements for all participants, with Black/African American participants showing a clinically relevant 0.7% overall reduction.

Long-term Glycemic Control in Adult Participants Using Control-IQ Technology: Real-World Evidence³

This study assessed baseline HbA1c and glucose management indicator derived from sensor data from 1,107 adults using Control-IQ technology for 12 consecutive months. Data demonstrated significant glycemic improvements, regardless of prior therapy modality.

Multiple daily injection users with relatively high HbA1c values initiating Control-IQ technology showed dramatic and sustained glycemic improvements. Previous pump users also demonstrated immediate and sustained improvements, continuing to build on evidence that all users can benefit from Control-IQ technology regardless of prior therapy.

“Demonstrating that our technology benefits ethnically diverse groups, irrespective of previous therapy modality, is critical to fulfilling our mission to improve the lives of people living with diabetes worldwide,” said Steph Habif, EdD, MS, Vice President, Behavioral Sciences at Tandem Diabetes Care. “As a global leader in insulin therapy management, we strive to provide diabetes care solutions that work equally well across all people living with diabetes, and the data presented at this conference is evidence of our success toward this goal.”

References

1. Singh H, Alencar G, Sanchez H, et al. Psychosocial Benefits of using the t:slim X2 Insulin Pump with Control-IQ technology: Long-term Outcomes from a Multi-ethnic Adult Cohort with Type 1 Diabetes. Oral presentation at 82^nd Scientific Sessions of the American Diabetes Association; June 3-7, 2022; New Orleans, LA.

2. Habif S, Graham R, Singh H, et al. Evaluation of long-term glycemic outcomes by ethnicity in adults with type 1 diabetes using the t:slim X2 insulin pump with Control-IQ technology. Poster presented at 82^nd Scientific Sessions of the American Diabetes Association; June 3-7, 2022; New Orleans, LA.

3. Pinsker J, Graham R, Singh H, et al. Long-term Glycemic Control in Adult Participants Using the t:slim X2 Insulin Pump with Control-IQ Technology: Real-World Evidence. Poster presented at 82^nd Scientific Sessions of the American Diabetes Association; June 3-7, 2022; New Orleans, LA.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company based in San Diego, California, creates new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience. The company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Tandem manufactures and sells the t:slim X2 insulin pump with Control-IQ technology. For more information, visit tandemdiabetes.com.

Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2, #ADA2022 and $TNDM.

Follow Tandem Diabetes Care on Facebook at facebook.com/TandemDiabetes.

Follow Tandem Diabetes Care on LinkedIn at linkedin.com/company/tandemdiabetes.

Responsible use of Control-IQ technology

Control-IQ technology does not prevent all highs and lows. Users must still bolus for meals and actively manage their diabetes. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

Important Safety Information: RX ONLY. The t:slim X2 pump and Control-IQ technology are intended for single patient use. The t:slim X2 pump and Control-IQ technology are indicated for use with NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology is an alternate controller enabled (ACE) pump that 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 t:slim X2 pump is indicated for use in individuals six years of age and greater. Control-IQ technology: Control-IQ technology is intended for use with a compatible integrated continuous glucose monitor (iCGM, sold separately) and ACE pump 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 six years of age and greater.

BOXED WARNING: Control-IQ technology should not be used by anyone under the age of six 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 the t:slim X2 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 t:slim X2 pump, and the CGM transmitter and sensor must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

© 2022 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, Control-IQ, and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All third-party marks are the property of their respective owners.

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