Game-changer for diabetes? Tandem’s Control-IQ+ automated insulin delivery system now available in the US

Tandem Diabetes Care, Inc. (NASDAQ: TNDM) has officially launched its Control-IQ+ automated insulin delivery system in the United States, marking a significant step forward in diabetes technology. This next-generation insulin automation solution, integrated with the t:slim X2 insulin pump and the Tandem Mobi System, is now available for individuals as young as two years old with type 1 diabetes and for adults managing type 2 diabetes.

The rollout of Control-IQ+ follows the United States Food and Drug Administration (FDA) clearance, making it one of the most advanced automated insulin delivery technologies on the market. New pumps will be pre-loaded with the updated software, while existing customers with in-warranty devices can access the upgrade remotely at no additional cost.

John Sheridan, president and chief executive officer of Tandem Diabetes Care, stated that Control-IQ+ represents an evolution in insulin automation, offering a higher degree of personalization without sacrificing the ease of use that has made Tandem’s insulin technology a leader in the field.

How Does Control-IQ+ Improve Automated Insulin Delivery?

The Control-IQ+ insulin automation system builds upon the foundation of its predecessor, introducing enhanced adaptability for a wider range of users. The new version supports individuals with body weights ranging from 20 to 440 pounds and total daily insulin needs between 5 and 200 units, significantly expanding access to individuals with varied insulin requirements.

Another key enhancement is the ability to extend bolus delivery for up to eight hours, a crucial feature for individuals managing meals that lead to prolonged glucose rises. Users can also make temporary basal rate adjustments while Control-IQ+ is active, allowing for real-time insulin delivery modifications in response to activities such as exercise, stress, or illness.

Retaining Tandem’s AutoBolus feature, Control-IQ+ continues to make automatic corrections every five minutes based on predictive glucose values, reducing the burden of manual insulin adjustments. This builds on extensive research showing that automated insulin delivery improves glucose control and reduces the risk of hypoglycemia compared to standard multiple daily injections.

Dr. Paul Wadwa, director of the pediatric diabetes clinic at the Barbara Davis Center for Diabetes, noted that automated insulin delivery systems such as Control-IQ+ offer substantial benefits, including improved sleep, better glycemic control, and reduced adverse events. He emphasized that these outcomes are particularly valuable for children and their caregivers, reducing the stress associated with manual diabetes management.

What Led to FDA Approval for Type 2 Diabetes Use?

The FDA’s recent approval of Control-IQ+ for type 2 diabetes insulin management marks a pivotal development for adults who require intensive insulin therapy. Historically, automated insulin delivery systems have primarily been tailored for type 1 diabetes, leaving individuals with type 2 diabetes reliant on multiple daily injections or less automated pump solutions.

This regulatory expansion was based on a large-scale clinical trial evaluating over 300 adults with type 2 diabetes. Participants using the t:slim X2 pump with Control-IQ+ insulin automation were compared to a control group managing diabetes with multiple daily injections. Both groups were equipped with a Dexcom G6 Continuous Glucose Monitoring (CGM) System throughout the study period.

Findings demonstrated that individuals using Control-IQ+ insulin technology achieved greater time in range, improved glycemic control, and an overall reduction in diabetes-related complications compared to those relying on traditional injection-based therapy. These results reinforce the growing recognition that automated insulin delivery can play a transformative role in the management of type 2 diabetes.

The full study findings will be presented at the 18th International Conference on Advanced Technologies & Treatments for Diabetes in Amsterdam in March 2025.

Dr. Jordan Pinsker, chief medical officer at Tandem Diabetes Care, highlighted the significance of this expansion, noting that over 2 million adults in the United States rely on intensive insulin therapy to manage type 2 diabetes. He emphasized that access to automated insulin delivery for type 2 diabetes represents a major step toward improving health outcomes for a population that has historically had limited options for advanced diabetes technology.

How Is the Market Responding to Tandem Diabetes Care’s Expansion?

While Control-IQ+ positions Tandem Diabetes Care as a leader in diabetes technology innovation, its stock has faced notable fluctuations. As of March 19, 2025, TNDM closed at $20.06, reflecting a 1.8% increase from the previous trading day. However, in February, Tandem Diabetes Care issued a conservative revenue projection for 2025, forecasting $997 million to $1.007 billion in revenue—slightly below analyst expectations. This led to a 35.3% decline in the stock price, dropping to $21.75 as investors reacted to the lower-than-anticipated outlook.

Despite this short-term volatility, analyst sentiment remains mixed. As of mid-March, the stock carries a “Moderate Buy” rating, with 11 out of 18 analysts recommending a buy and seven suggesting a hold. The average 12-month price target of $45.38 indicates significant potential upside. However, Citigroup recently downgraded TNDM stock from “Buy” to “Neutral,” lowering its price target from $35 to $24 due to concerns over market competition and revenue growth projections.

Is Insider Confidence Growing in Tandem Diabetes Care?

Despite market uncertainty, insider buying activity suggests confidence in Tandem Diabetes Care’s long-term growth. On March 7, 2025, Chief Operating Officer Jean-Claude Kyrillos purchased 10,538 shares at an average price of $18.12 per share, totaling approximately $190,949. Such moves are often interpreted as signals of optimism regarding a company’s future performance.

Investors will be watching key factors, including quarterly earnings reports, Control-IQ+ adoption rates, and potential healthcare partnerships, to assess the company’s financial trajectory.

What Lies Ahead for Tandem Diabetes Care?

As the automated insulin delivery industry continues to evolve, the expansion of Control-IQ+ insulin automation represents a strategic move to broaden Tandem Diabetes Care’s market reach. The integration of artificial intelligence in diabetes technology, coupled with increased adoption of hybrid closed-loop insulin systems, is expected to shape the next phase of diabetes management solutions.

While the company faces market challenges, the success of Control-IQ+ insulin delivery for type 2 diabetes could establish Tandem Diabetes Care as a leader in both advanced diabetes technology and automated insulin therapy. Investors, healthcare providers, and individuals managing diabetes will closely monitor how this latest innovation reshapes the industry.