Medtronic says real-world data show its MiniMed 670G glucose management system increased time in range for people with diabetes.
Medtronic has announced clinical outcomes for the MiniMed 670G system, saying that real-world users with diabetes had an average time in range of of 71% across all age groups, according to a company statement. Time in range is the percentage of time people with diabetes have an optimal glycemic range between 70 and 180 mg/dL.
However, the company was careful to note that those who used the system's "Auto Mode," which includes the most advanced hybrid closed loop features, had the most positive outcomes. These users had an average 2.3 hours additional time in range, which translates into 35 additional days per year that with peopel with diabetes could spend in the target glucose range.
Historically, diabetes care experts monitored a person's glycated hemoglobin (A1C), which represents a 3-month average of blood glucose levels. But with the advent of continuous glucose monitoring technology, more experts are paying attention to time in range, because research shows that patients who avoid swings in hyper- and hypoglycemia avoid long-term macrovascular and microvascular complications of diabetes, including heart disease, strokes, retinopathy, and renal decline.
"The consistent data across a large sample in the real world illustrates the positive outcomes with the MiniMed 670G in an uncontrolled environment," said Satish Garg, MD, professor of Medicine and Pediatrics and director of the Adult Diabetes Division of the Barbara Davis Center of the University of Colorado. "Since the launch of the system in 2017, there has been a growing body of data that show that the system consistently improves time in range in a majority of the patients who successfully are able to stay in the Auto Mode surpassing that of other commercially available methods of Type 1 diabetes management. These observations in a real-world setting of what was initially observed in the controlled pivotal trial of the system are impressive. The MiniMed 670G represents the highest standard of care for diabetes today."
The MiniMed 670G was the first glucose management system to achieve FDA's designation of an artificial pancreas device system when it was approved in September 2016. Currently used by over 180,000 people, the MiniMed 670G combines an insulin pump and the Guardian sensor 3, with an algorithm to automate insulin delivery of basal insulin 24 hours a day. The sensor monitors glucose levels and sends data to the pump every 5 minutes to regulate insulin delivery to keep glucose levels targeted at 120mg/dL throughout the day, which is the lowest range offered in an automated insulin pump system.
Data analysis also revealed that the most advanced features of the MiniMed 670G system reduced low glucose episodes of less than 70mg/dL, that lasted more than 20 minutes, by 28% and high glucose episodes of more than 250mg/dL, that lasted over 3 hours, by 55% annually.
"Clinical consensus about time in range is that the goal of effective diabetes management is to have a person be in the recommended range of 70-180 mg/dL for at least 70% of time. This may increase the likelihood that short and long-term complications of this chronic disease can be avoided," said Robert Vigersky, MD, chief medical officer for the Diabetes Group at Medtronic. "The high number of adult patients reaching and surpassing this time in range goal illustrates the strong positive outcomes that the MiniMed 670G system can drive. Improved time in range is also seen in children as young as 7 who face unique challenges with maintaining control due to a variety of factors including increased insulin sensitivity and cognitive, behavioral, and social-emotional development during this phase of life."
Mary Caffrey contributed to this report.