Automated Insulin Delivery Technology Receives FDA Clearance for Individuals With Type 2 Diabetes

A next generation automated insulin delivery (AID) algorithm, Control-IQ+ technology (Control-IQ+; Tandem Diabetes Care, Inc.) received FDA clearance for use among individuals aged 18 years and older with type 2 diabetes. The current indication expands on the previous Control-IQ+ clearance for use by individuals with type 1 diabetes.¹

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“Type 2 diabetes affects millions of Americans and increases the risk of serious health conditions, including heart disease, stroke, kidney disease, and nerve damage, reinforcing the importance of consistent management of blood sugar," Jordan Pinsker, MD, chief medical officer, said in a news release.¹

Symptoms of type 2 diabetes progress slowly, and most individuals are unaware they are living with the disease for years following initial development. Notable signs include more thirst; more urination; more hunger; weight loss; tiredness; blurred vision; slow-healing sores; frequent infections; numbness or tingling in the hands or feet; and areas of darkened skin. While there is no cure for type 2 diabetes, medicine or insulin therapy is often used to manage blood sugar when diet and exercise are not enough.²

“More than 2 million people in the U.S. rely on intensive insulin therapy to manage their type 2 diabetes, and we are proud to bring this life-changing technology to a group that has historically had limited options for diabetes management.”¹

Control-IQ uses 2 Tandem insulin delivery systems—the t:slim X2 insulin pump and the Tandem Mobi.¹ The t:slim X2 insulin pump with Control-IQ automatically adjusts insulin delivery to predict and help prevent highs and lows.³ Tandem Mobi also aids prevention and helps maintain blood sugars in range by using continuous glucose monitoring (CGM) values to predict glucose levels 30 minutes ahead to automatically adjust insulin delivery.⁴

“We have seen firsthand, through numerous clinical and real-world studies, how Control-IQ has improved health outcomes and quality of life for our users with type 1 diabetes,” John Sheridan, president and chief executive officer, said in a news release.¹

Previous studies published in October 2019, August 2020, and March 2023 by the New England Journal of Medicine found that Control-IQ demonstrated immediate and sustained glycemic improvements, including more time in range and improved sleep among individuals with type 1 diabetes.¹

“Studies using Control-IQ technology have shown impressive results in different age groups, now in a sequence of randomized controlled trials published by the New England Journal of Medicine, demonstrating more time in range with low risk of hypoglycemia,” said Paul Wadwa, MD, professor of pediatrics at the Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus and protocol chair for the PEDAP Clinical Trial, in a news release.⁵

The current expanded label indication for type 2 diabetes is based on results from a first large-scale, randomized, completed pivotal control trial that evaluated the automated insulin delivery system in over 300 individuals with type 2 diabetes. The study assessed the use of the t:slim X2 pump with Control-IQ in a control group that continued treatment with their existing daily injection regimens. However, both groups used a Dexcom G6 CGM system throughout the study period.¹

The study authors noted that full results from the pivotal trial will be presented in March 2025 at the 18th International Conference on Advanced Technologies & Treatments for Diabetes taking place in Amsterdam, the Netherlands.¹

“It is a natural evolution of our mission to bring the same AID technology that helped to make Tandem the #1 recommended insulin pump brand by both healthcare providers and people living with type 1 diabetes to adults with type 2.”¹

REFERENCES

1. Tandem Diabetes Care Announces FDA Clearance of Control-IQ+ Automated Insulin Delivery Technology for People with Type 2 Diabetes. Tandem Diabetes Care. News release. Published February 25, 2025. Accessed March 4, 2025. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-fda-clearance-control-iq

2. Type 2 diabetes. Mayo Clinic. News release. Updated February 27, 2025. Accessed March 4, 2025. https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/symptoms-causes/syc-20351193

3. t:slim X2 Insulin Pump. Tandem Diabetes Care. News release. Accessed March 4, 2025. https://www.tandemdiabetes.com/landing-pages/t-slim-x2?utm_source=google&utm_medium=cpc&utm_campaign=NPD-GGL-BR-Brand-Tier2&utm_term=tandem%20tslim%20x2&gad_source=1&gclid=Cj0KCQiAy8K8BhCZARIsAKJ8sfRyT8y2uTJ7tsSBPX0GpklpIjRZccYuwPXNIo-Q3M2ckEWLkKz4760aAr75EALw_wcB

4. Tandem Mobi System. Tandem Diabetes Care. News release. Accessed March 4, 2025. https://www.tandemdiabetes.com/products/insulin-pumps/tandem-mobi

5. Tandem Diabetes Care Announces NEJM Publication of Study Demonstrating Increased Time in Range in Young Children with Type 1 Diabetes Using the t:slim X2 Insulin Pump with Control-IQ Technology. Tandem Diabetes Care. News release. Published March 15, 2023. Accessed March 5, 2025. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-nejm-publication-study