Medtronic (NYSE:MDT) today presented positive study results for its InPen smart insulin pen and its extended-wear infusion set.
Fridley, Minn.-based Medtronic touted real-world clinical results comparing glycemic outcomes for 1,736 individuals before and after using the InPen smart insulin pen for 90 days with a continuous glucose monitor (CGM).
According to a news release, data from the real-world study demonstrated an increase in time-in-range of 2.3% for those whose glucose management indicator (GMI) was >8% and an increase of 5% time-in-range for people whose GMI was >9.5%. For both groups, no subjects experienced an increase in time below range (hypoglycemia) during the study period.
The company also touted data showing that the InPen provided improved dosing decision support as demonstrated by fewer total doses per day and improved glycemic control. The average daily insulin bolus frequency decreased (from 3.7 to 3.6/day and 3.3 to 3.2/day, respectively, for each group). The total rapid-acting daily insulin dose increased (from 26.29 to 27.19 u/day and 27.57 to 29.24 u/day, respectively, for each group), based on data aggregated from individuals who uploaded between January 2018 and October 2020 with a minimum of 30 days of CGM data pre- and post-InPen initiation.
“Smart insulin pens that automatically track insulin doses and calculate active insulin are emerging as important advances in diabetes management technology because they increase the amount of time spent in the preferred glucose range without increasing hypoglycemia,” Park Nicollet International Diabetes Center (Minneapolis) medical director Dr. Anders Carlson said in the release. “It’s encouraging to see that positive clinical gains are possible with the use of consumer-friendly diabetes technology, such as InPen, that makes it simple for patients to track insulin dosing, calculate doses and receive reminders and other decision support that allows them to manage their diabetes more effectively without adding a lot of complexity.”
In addition to the InPen data, Medtronic presented U.S. pivotal trial data for its Medtronic Extended infusion set, which it touts as the first and only infusion set that can be worn for up to seven days.
Data covered the safety and performance of 259 individuals between ages 18 and 80 years old who wore traditional 2-day or 3-day infusion sets with the MiniMed 670G system for two weeks, followed by 12 consecutive wears of the Medtronic Extended infusion set.
The study showed no significant increase in the total daily dose of insulin, indicating that the Medtronic Extended infusion set delivers insulin successfully throughout the seven-day wear time. Additionally, no adverse events were observed, Medtronic said. The Medtronic Extended infusion set is limited to investigational use in the U.S. but is CE marked in Europe.
“For decades, insulin infusion sets needed to be changed every two to three days. So, the development of an extended infusion set that can be worn for up to seven days represents a significant improvement in the patient experience,” Stanford emeritus professor of pediatrics & endocrinology Dr. Bruce Buckingham said. “The pivotal trial demonstrated the safety of the new infusion set as well as increased satisfaction from being able to wear it longer.
“Alleviating the burden of changing infusion sets every two to three days is a very meaningful improvement in the overall pump experience. This important innovation in the infusion set will make insulin pump therapy feel easier for many patients.”