SAN DIEGO–(BUSINESS WIRE) – Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leader in insulin delivery and diabetes technology, this week announced real-world data on the t: slim X2 ™ insulin pump with Control-IQ ™ Advanced Hybrid Closed-Loop -Technology at the 14th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD). Several presentations detailed positive results, including a plenary session today by Boris Kovatchev, PhD, director of the Center for Diabetes Technology at the University of Virginia, which showed immediate and sustained improvement in time-in-range (TIR) in more than 9,000 people with diabetes Showed who had worn the system for 12 months.
“Experience is important with automated insulin dosing systems, and Control-IQ technology works just as well in the field as it does in the pivotal studies,” said Dr. Jordan Pinsker, Medical Director at Tandem Diabetes Care. “In addition, patient-reported results, including lower diabetes exposure and improved sleep quality, show that our Control-IQ technology can have a positive and lasting impact on the lives of people with diabetes.”
ATTD PRESENTATION SUMMARY
Glycemic Trends in People with Type 1 Diabetes Based on When Control-IQ Technology was Introduced.
Session: 270 – Oral Presentation 08
Thursday, June 3, 2021 @ 20:30 – 21:40 CET
This presentation reported on glycemic trends in people with type 1 diabetes based on the timing of the introduction of the t: slim X2 insulin pump with Control-IQ technology. The study sample comprised 6,233 people with type 1 diabetes who had started using Control-IQ technology between its introduction (January 15, 2020) and July 15, 2020. The participants were divided into three groups according to when they were introduced: within four weeks of introduction (group A), between 3-4 months (group B) and 5-6 months (group C). Regardless of when Control-IQ technology was introduced, significant improvements in sensor TIR were seen in all groups.
Quality of life and blood sugar control with the t: slim X2 pump with Control-IQ technology – practical observations from the CLIO study.
Session: 360 – Oral Presentation 11
Friday, June 4th 2021 @ 5:15 – 6:25 pm CET
This presentation reported on the results of the ongoing Control-IQ Observational (CLIO) study, which examined the real use of the t: slim X2 insulin pump with Control-IQ technology in different groups of people with type 1 diabetes. The study sample comprised 700 participants from different ethnic groups who had uploaded pump data to the t: connect ™ web application (Tandem Diabetes Care, USA only) for at least 21 days and who had used at least 75 percent CGM during this time. Participants took patient-reported outcome measurements at baseline and three months after baseline. The continued use of the t: slim X2 pump with Control-IQ technology resulted in a sensor time in the range of 72.5 percent (median, IQR = 71-73 percent) and a sensor time <70 mg / dl of 1.1 percent (Median, IQR = 1.3-1.2 percent). Coupled with improved glycemic profiles, data from validated quality of life surveys conducted by participants at baseline and after three months showed a significant reduction in the effects of diabetes and greater satisfaction with Control-IQ technology compared to their previous insulin delivery devices.
Plenary Session: Advances in Closed-Loop Systems – Lessons from Clinical Trials.
Plenary session 03
Friday, June 4th 2021 @ 6:30 pm – 8:05 pm CET
Boris Kovatchev, Ph.D. from the Centers for Diabetes Technology at the University of Virginia presented results from 12 consecutive months of real-world use of Control-IQ technology, representing more than 1 billion data points analyzed. The results showed a total median time in the range of 73.6% (10% increase from baseline, 63.6%) reflecting the results from the pivotal studies. The average percentage of time in automation or “closed loop” was 94.2%. The median percentage of time below 70 mg / dL remained constant at approximately 1%.
Corporate Symposium: Catching Some ZZZs. A symposium on user experience and clinical results with the t: slim X2 insulin pump with Control-IQ technology.
Friday, June 4th, 2021 @ 5:15 pm-6:15pm CET
This symposium included three short presentations that provided insights and information about the Control-IQ algorithm and system performance, patient-reported results on quality of life, and implications for clinical practice. Real-world analyzes of more than 72,000 people with Control-IQ technology showed significant improvements in nightly glycemic control. Validated patient-reported outcome measures were used to qualitatively confirm a decrease in the burden of diabetes and an increase in device satisfaction. Specific case studies provided guidance for practitioners to optimize patient expectations and experiences.
A recording of the corporate symposium is available at https://www.tandemdiabetes.com/providers/connect-with-us/events.
Via Control-IQ Advanced Hybrid Closed-Loop Technology
The t: slim X2 insulin pump with Control-IQ technology uses Dexcom G6 CGM values in conjunction with other variables such as insulin on board to predict sensor glucose levels 30 minutes in advance and adjust insulin delivery accordingly. Technology is designed to extend the sensor time in range by automatically increasing, decreasing, or stopping insulin delivery, or by delivering an automatic correction bolus based on predicted glucose levels. Control-IQ technology also offers optional sleep and exercise settings that change treatment values to better meet different physiological needs during these activities.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com) is a medical technology company dedicated to improving the lives of people with diabetes through relentless innovation and revolutionary customer experiences. The company takes an innovative, user-centric approach to the design, development and marketing of products for people with diabetes who use insulin. Tandem produces and sells the t: slim X2 insulin pump with Control-IQ technology. The t: slim X2 pump can perform remote function updates via a PC and is the only automatic insulin dosing device approved for children aged six and over. Tandem is based in San Diego, California.
Important safety notice:
The t: slim X2 insulin pump with Control-IQ technology (the system) consists of the t: slim X2 insulin pump, which contains the Control-IQ technology, and a compatible continuous glucose monitor (CGM, sold separately). The t: slim X2 insulin pump is intended for the subcutaneous administration of insulin at fixed and variable rates for the treatment of diabetes mellitus in insulin-dependent people. The t: slim X2 insulin pump can only be used 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 levels. The system can also deliver corrective boluses when it is predicted that the glucose level will exceed a predefined threshold. The pump and the system are intended for people aged six and over. The pump and system are intended for single use. The pump and system are indicated for use with NovoRapid or Humalog U-100 insulin. The system is intended for the treatment of type 1 diabetes.
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WARNING: Control-IQ Technology should not be used by anyone under the age of six. It should also not be used in patients who need less than 10 units of insulin per day or who weigh less than 25 kg. |
The system is not indicated for pregnant women, dialysis patients or seriously ill users. Do not use the system if you are using hydroxyurea.
Users of the pump and system must: be ready and able to use the insulin pump, CGM, and all other system components in accordance with their respective directions for use; Test blood sugar levels as recommended by your doctor; demonstrate adequate carbohydrate counting skills; maintain adequate self-sufficiency skills in diabetes; see health care providers regularly; and have sufficient eyesight and / or hearing to recognize all functions of the pump, including warnings, alarms, and reminders. The t: slim X2 pump as well as the CGM transmitter and sensor must be removed before an MRI, CT or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for more important safety information.
© 2021 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, t: slim X2, Control-IQ, and t: connect are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and / or other countries. Dexcom and Dexcom G6 are either registered trademarks or trademarks of Dexcom, Inc. in the United States and / or other countries. All third party trademarks are the property of their respective owners.
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1 If glucose alarms and CGM readings are inconsistent with symptoms or expectations, or if you are taking the maximum recommended dose of 1000 mg acetaminophen every 6 hours, use a blood glucose meter to help you make diabetes treatment decisions.
2 Dexcom G6 CGM sold separately.
3 The Dexcom G6 CGM transmitter can only pair with one medical device (either a Dexcom receiver or a t: slim X2 pump) and one consumer device (phone or tablet) at the same time.
