Aggregated real-world outcome data collected from thousands of Medtronic MiniMed 670G users indicate that patients on the system spend an average 71% of their time within an optimal glycemic range.
Collected from nearly 8 million days of recorded system use and announced by Medtronic today in a press release, the new findings also suggest that this rate increased further for those who employed the system’s automated background insulin measurement and delivery feature.
"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," Dr. Robert Vigersky, chief medical officer for the diabetes group at Medtronic, said in a statement.
"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 seven 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,” he said.
According to the company, those who used the system’s advanced features — which a Medtronic spokesperson specified to be the MiniMed 670G’s “Auto Mode” function — spent 2.3 additional hours within optimal glycemic range per day compared to those who did not use the hybrid closed loop system feature. These users also saw substantial reductions in the frequency of 20-minute-or-longer low glucose episodes (28%) and 3-hour-or-longer high glucose episodes (55%).
WHY IT MATTERS
Both hypoglycemia and hyperglycemia come with a slew of unpleasant symptoms, contribute to chronic disease complications and in some cases can lead to coma or death. However, consistently remaining within the optimal blood glucose range is an inconvenience for some patients, and a major challenge for others.
The MiniMed was the first device cleared by the FDA that combined a continuous glucose monitor and an insulin pump to streamline glucose management, and has since seen further refinements and clearances for use on the upper arm and among children aged seven years or older with Type 1 diabetes. These new data not only highlight the role Medtronic’s system can play for these patients, but may also help satisfy the agency’s requirement that the company provide post-market evidence of its system’s effectiveness.
WHAT’S THE TREND
The past year or so has seen a steady trickle of favorable data for Medtronic’s glucose management system. Last summer the device maker and UnitedHealthcare released one-year plan data suggesting that members who received the systems through a UnitedHealthcare program experienced fewer preventable hospital admissions. A few months prior saw the results of a pediatric investigation that likely paved the way for the FDA’s expanded approval for the system.
Medtronic may be a leading name in the space (closely followed by competitors working on their own closed loop systems), but some patients have taken to devising their own system using interoperable devices. The FDA recently issued a warning to these users highlighting the dangers of unvetted algorithms and device combinations.
