Real-World Evidence Confirms Immediate and Ongoing Performance of the t:slim X2 Insulin Pump with Control-IQ Technology in Children and Adults

BARCELONA, Spain–(BUSINESS WIRE)–$TNDM #ATTD2022–Tandem Diabetes Care, Inc. (NASDAQ:TNDM), a global insulin delivery and diabetes technology company, announced real-world data confirming that use of the t:slim X2™ insulin pump with Control-IQ® advanced hybrid closed-loop technology resulted in immediate and ongoing improvements in glycemic control, quality of life outcomes, and user-reported reduced burden of diabetes management.¹ The data was presented today at the 15^th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Barcelona, Spain.

“Experience matters. And with more than 60 million real-world patient-use days in the United States, and even more globally, our Control-IQ technology continues to set the high-bar in advanced automated insulin dosing,” said Jordan Pinsker, MD, Vice President and Medical Director at Tandem Diabetes Care. “The data presented at ATTD further reinforces the strength of Control-IQ technology in both clinical- and patient-reported outcomes, and we are proud of the positive impact and increased freedom people report experiencing through the use of our technology solutions.”

U.S. Presentations Including Control-IQ Technology

Much of the evidence presented at ATTD comes from the Control-IQ Observational (CLIO) study, an ongoing real-world evaluation of people with type 1 diabetes using the t:slim X2 pump with Control-IQ technology.

Control-IQ Observational (CLIO) Longitudinal Study Results at 9 Months

This analysis included data from 1,913 participants from the CLIO Study who had at least 9 months experience using Control-IQ technology, and examined relationships between glycemic metrics, participants’ age, and previous insulin delivery method.

The data demonstrated successful adoption of Control-IQ technology by people previously using multiple daily injections (MDI) or other devices. In addition, it demonstrated the efficacy of long-term use across all age cohorts ranging from pediatrics to 65-plus.²

CLIO Study Patient Reported Outcomes (PRO) at 6 Months

This analysis included data from 2,062 CLIO participants and compared PROs before initiating and after 6 months of use of Control-IQ technology.

Data demonstrated Control-IQ technology users experienced improved quality of life, reduced diabetes burden, and higher satisfaction with diabetes therapy irrespective of age, baseline HbA1c, and previous insulin delivery method.

Time of Initiation of Advanced Hybrid-Closed Loop Therapy and Related Glycemic Outcomes in People with Type 1 Diabetes Transitioning from MDI

Separate from the CLIO study, researchers retrospectively studied the first 90 days of pump activation in MDI users transitioning to the t:slim X2 pump with Control-IQ technology. More than 17,500 individuals were evaluated.

The results showed that 95 percent of MDI users successfully initiated Control-IQ technology within 14 days of pump start. All groups experienced success with Control-IQ technology. However, the group that delayed initiation the longest showed a lower time in range.³

International Presentations Including Control-IQ Technology

Peter Adolfsson, MD, senior physician, Hospital of Halland Kungsbacka, Sweden, and Andrea E. Scaramuzza, MD, of the Department of Pediatrics, Azienda Socio Sanitaria Territoriale, Cremona, Italy presented evidence outlining the long-term impact of Control-IQ technology use on children and their families in Europe.^4,5 Results from both studies demonstrated clear and continuous benefits of an advanced hybrid closed loop system compared to continuous subcutaneous insulin infusion and MDI. Specifically, glucose control was significantly improved within one month of Control-IQ technology use and sustained throughout a consecutive 12-month period.

“This evidence suggests Control-IQ technology users experience significantly greater quality of life without compromising clinical outcomes,” said Steph Habif, EdD, MS, Vice President of Behavioral Sciences. “Our systems are designed to help relieve the burden of diabetes management and these studies support that we are successfully achieving this objective and other positive outcomes for our Control-IQ technology users.”

References

¹ Singh H, Alencar G, Manning M, et al. Long-Term Improvements In Patient-Reported Outcomes Irrespective of Baseline Glycemic Control and Previous Insulin Delivery Method with the t:Slim X2 Pump with Control-IQ Technology. Poster presented at 15^th Annual International Conference on Advanced Technologies & Treatments for Diabetes (ATTD); April 27-30, 2022; Barcelona, Spain.

² Graham R, Singh H, Mueller L, et al. Glycemic Outcomes by Age and Previous Insulin Delivery Method in Control-IQ Technology Users: 9 Months of CLIO Study Data. Poster presented at 15^th Annual International Conference on Advanced Technologies & Treatments for Diabetes (ATTD); April 27-30, 2022; Barcelona, Spain.

³ Mueller L, Singh H, Habif S, et al. Time of Initiation of Advanced Hybrid-Closed Loop Therapy and Related Glycemic Outcomes in People with Type 1 Diabetes Transitioning from Multiple Daily Injections. Poster presented at 15^th Annual International Conference on Advanced Technologies & Treatments for Diabetes (ATTD); April 27-30, 2022; Barcelona, Spain.

⁴ Scaramuzza AE. 1 Year Follow Up on Control-IQ Technology after Virtual Pediatric Camp. Poster presented at 15^th Annual International Conference on Advanced Technologies & Treatments for Diabetes (ATTD); April 27-30, 2022; Barcelona, Spain.

⁵ Adolfsson P, Björnsson V, Heringhaus A, Sjunnesson K. A Prospective Controlled Study Evaluating the Long-Term Outcomes on Glucose Control, Sleep, and Health Economy After Implementation of Tandem Control-IQ Technology in a Pediatric Population with Relatively Good Glucose Control Already At Start. Poster presented at 15^th Annual International Conference on Advanced Technologies & Treatments for Diabetes (ATTD); April 27-30, 2022; Barcelona, Spain.

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, #ATTD2022 and $TNDM.

Follow Tandem Diabetes Care on Facebook at ww.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: The t:slim X2 insulin pump with Control-IQ technology (the System) consists of the t:slim X2 insulin pump, which contains Control-IQ technology, and a compatible continuous glucose monitor (CGM, sold separately). The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The t:slim X2 insulin pump can be used solely for continuous insulin delivery and as part of the System. When used with a compatible CGM, the System can be used to automatically increase, decrease, and suspend delivery of basal insulin based on CGM sensor readings and predicted glucose values. The System can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. The pump and the System are indicated for use in individuals six years of age and greater. The pump and the System are intended for single user use. The pump and the System are indicated for use with NovoRapid, Admelog (Canada only), or Humalog U-100 insulin. The System is intended for the management of Type 1 diabetes.

WARNING: Control-IQ technology should not be used by anyone under the age of six years old. It should also not be used in users who require less than 10 units of insulin per day or who weigh less than 25 kilograms.

The System is not indicated for use in pregnant women, people on dialysis, or critically ill users. Do not use the System if using hydroxyurea.

Users of the pump and the System must: be willing and able to 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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