Medtronic InPen™ Real-World Data and Extended Infusion Set* Pivotal Trial Results Demonstrate Strong Clinical Outcomes and Positive User Experience
Data Were Presented at the American Diabetes Association 81st Scientific Sessions
DUBLIN, June 28, 2021 /PRNewswire/ -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced key clinical data from the virtual 81st annual American Diabetes Association Scientific Sessions. The presentations illustrated increases in Time in Range when using an InPen™ smart insulin pen, safety of an extended-wear infusion set that lasts up to 7 days, and patient satisfaction with the longer-wear infusion set.
InPen Smart Insulin Pen Data
Using InPen smart insulin pen also provided improved insulin dosing decision support for those in the study as demonstrated by fewer total doses per day with simultaneously 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) and total rapid acting daily dose of insulin increased (from 26.29 to 27.19 u/day and 27.57 to 29.24 u/day, respectively, for each group). This real-world performance analysis aggregates information from individuals who uploaded their data from January 2018 to October 2020. A minimum of 30 days of CGM data pre- and post-InPen start were required to be part of the analysis.
"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," said Dr. Anders Carlson, medical director of the Park Nicollet International Diabetes Center (IDC) in Minneapolis, Minn. "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."
Medtronic Extended Infusion Set Data
During the pivotal study, the same group of patients compared their experience of wearing a 2- or 3-day set to wearing the new 7-day Medtronic extended infusion set. Overall, patients preferred the longer-wear set, rating it higher on ease of insertion, comfort of wear, duration of wear, time required to change infusion set and convenience.
"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," said Bruce Buckingham, M.D., emeritus professor of pediatrics and endocrinology at Stanford. "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."
* In the United States, Medtronic Extended infusion set is limited to investigational use only and not approved for sale, while in Europe it is already CE marked.
About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)
Due to inherent study limitations, caution is advised when attempting to extrapolate these results to new patients. There could be significant differences.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 Smart insulin pens connect to a mobile app to provide dosing calculations, reminders and CGM system integration.
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SOURCE Medtronic plc
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