Real-world outcomes using the Tandem Mobi insulin pump with Control-IQ+ technology and Dexcom G7

Area of Science:

• Endocrinology
• Medical Devices
• Diabetes Technology

Background:

• Limited real-world data exists for the Tandem Mobi insulin pump with Control-IQ+ technology, especially with newer sensors and diverse populations.
• Previous evaluations were based on small, early access studies.

Purpose of the Study:

• To evaluate the real-world performance and safety of the Tandem Mobi insulin pump integrated with the Dexcom G7 continuous glucose monitor (CGM).
• To assess the effectiveness of the Control-IQ+ automated insulin delivery algorithm in a large, diverse user population.

Main Methods:

• Analysis of data from 29,265 users of the Tandem Mobi pump and Dexcom G7 CGM system.
• Inclusion criteria required at least 30 days of system use, tracked via the Tandem Source web application.
• Inclusion of data from customer service check-in surveys for postmarket surveillance.

Main Results:

• High CGM availability (median 97.8%) and closed-loop time (median 94.1%) were achieved.
• Median time in range (3.9-10.0 mmol/L) was 70.8% for adults, 62.3% for older children, and 59.5% for younger children.
• Low time below range (<3.9 mmol/L) at 1.4% and high user satisfaction reported for pump usability and algorithm performance.

Conclusions:

• The Tandem Mobi insulin pump with Control-IQ+ technology and Dexcom G7 sensor demonstrates safe and effective use in unsupervised, at-home settings.
• The system provides reliable performance and positive clinical outcomes across various age groups.
• Real-world data supports the efficacy of this integrated diabetes management system.