SAN DIEGO–(BUSINESS WIRE)–November 10, 2022–
Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading diabetes technology and insulin delivery company, announced the results of a prospective, multicenter, single-arm study of adults living with type 2 diabetes that achieved a improvement in all clinical endpoints with the use of the t:slim X2 insulin pump with Control-IQ technology. 1
Presented today at the 22nd Annual Meeting of Diabetes Technology, data demonstrated the system to be safe over 6 weeks of use, with substantial improvement in time in range and mean glucose associated with a reduction in hyperglycemia and no increase in continuous glucose monitor (CGM). ) measured hypoglycemia.* Both previous users of multiple daily injections (MDI) and previous users of basal insulin alone showed similar levels of improvement. Study participants indicated a high level of satisfaction with the system.
“Our goal with this study was to show that Control-IQ technology was safe and could offer significant benefit to people with type 2 diabetes, and we achieved that,” said Carol Levy, MD, CDCES, study protocol director and professor of Medicine. (Division of Endocrinology, Diabetes and Bone Diseases) at the Icahn School of Medicine at Mount Sinai. “The 15% improvement in time in range over prior therapy represents a 3.6 hour per day increase in time in range, with no hypoglycemic events.”
“The results presented today are consistent with numerous studies supporting the benefits of pump therapy for people living with type 2 diabetes,” said Jordan Pinsker, MD, vice president and medical director of Tandem Diabetes Care. “People living with type 2 diabetes often take other medications in combination with their insulin therapy. The combination of safety results and high satisfaction scores seen in this population, who were able to continue on these existing medications during the study, shows that Control-IQ technology could be a powerful management solution for their therapy needs.”
- Use of Control-IQ technology was shown to be safe for 6 weeks of use
- The mean time on range for all participants improved by 15 percentage points, an increase of 3.6 hours per day
- Average time in range for previous MDI/pump users improved 16 percentage points
- Median time in range for previous Basal-only insulin users improved 13 percentage points
- The average time >180 mg/dl improved 15 percentage points, which represents a reduction of 3.6 hours per day
- Mean time >250 improved 5.6 percentage points, a reduction of almost an hour a day
- No increase in hypoglycemia measured by CGM
System performance and usability
- The mean time in closed circuit was 96%
- Study participants indicated a high level of satisfaction with the system
- Most participants used additional glycemic therapies in addition to insulin and continued to use them throughout the trial.
This prospective multicenter trial included 30 adults with type 2 diabetes from three clinical centers: Icahn School of Medicine at Mount Sinai, New York City, NY; Mayo Clinic, Rochester, MN; and Texas Diabetes and Endocrinology, Austin, TX. The study was coordinated by the JAEB Center for Health Research, in Tampa, FL. Participants with type 2 diabetes (mean age 54±12 years, mean HbA1c 8.6±1.2, mean BMI 31) using MDI (N=15), pump (N=2), or non-bolus basal insulin (N=13 ) collected unblinded (baseline) CGM data followed by an open-loop period before starting use of Control-IQ technology for 6 weeks.
Please note that Control-IQ technology is not approved for use in people with type 2 diabetes. This study was conducted under an investigational device exemption with a modified pump.
*Time in range is defined as 70-180 mg/dL.
1 Levy CJ, Raghinaru D, Kudva Y, et al. Significant reduction in hyperglycemia and high satisfaction with use of Control-IQ technology in prior MDI and basal insulin-only users with type 2 diabetes (T2D). Poster presented at the 22nd Annual Meeting of Diabetes Technology; November 10, 2022; Virtual.
This news 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, our goal of establishing that Control-IQ technology could be a powerful management solution for the therapy needs of people living with type 2 diabetes. These forward-looking statements are subject to numerous risks and uncertainties, including risks associated with the research and development process in general, such as the design, testing and validation of products and related systems in accordance with applicable regulatory and legal requirements in the markets in which we participate. service, our ability to develop, scale, and maintain systems, personnel, and infrastructure to support customers in various geographies and market segments, as well as other risks identified in our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-K. Form 10-Q and other documents we file with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Actual results could differ materially from those anticipated or projected in the forward-looking statements. Tandem undertakes no obligation to update or revise any forward-looking statements in this press release due to new information, future events or other factors.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc., a global diabetes technology and insulin management company headquartered 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, #2022DTM 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 ups and downs. Users must still administer meal boluses and actively manage their diabetes. Visit tandemdiabetes.com/safetyinfo for additional important safety information.
Important Safety Information:
Indications for use:
t:slim X2 insulin pump
The t:slim X2 insulin pump with interoperable technology is an Alternate Controller Enabled (ACE) pump designed for the subcutaneous administration of insulin, at fixed and variable rates, for the management of diabetes mellitus in people who require insulin. The pump can reliably and securely communicate with compatible digitally connected devices, including automated insulin delivery software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in persons six years of age and older. The pump is designed for single patient home use and requires a prescription. The pump is indicated for use with U-100 insulin only.
Control-IQ technology is designed for use with a compatible integrated continuous glucose monitor (iCGM, sold separately) and ACE pump to automatically increase, decrease, and suspend basal insulin delivery based on iCGM readings and ACE values. predicted glucose. You can also deliver correction boluses when your glucose value is expected to exceed a predefined threshold. Control-IQ technology is designed for the management of type 1 diabetes mellitus in people six years of age and older. Control-IQ technology is designed for single patient use. Control-IQ technology is indicated for use with U-100 insulin only.
CAVEAT: Control-IQ technology should not be used by children under the age of six. 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.
The system is not indicated for use by pregnant women, people on dialysis, or seriously ill users. Do not use the system if you use hydroxyurea.
Users of the pump and 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; measure blood glucose levels as recommended by your health care provider; demonstrate adequate carbohydrate counting skills; maintain sufficient diabetes self-management skills; see your health care provider(s) regularly; and have adequate vision and/or hearing to recognize all pump functions, including alerts, alarms, and reminders. The t:slim X2 pump and CGM transmitter and sensor must be removed prior to 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 trademarks are the property of their respective owners.
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SOURCE: Tandem Diabetes Care, Inc.
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PUB: 11/10/2022 17:22/DISC: 11/10/2022 17:23