June 28, 2021 – Medtronic plc (Dublin, Ireland) 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, the company says.
Medtronic presented real-world clinical results that compared glycemic outcomes for 1,736 individuals before and after using the InPen smart1 insulin pen for 90 days with a glucose monitor (CGM). Data showed an increase in Time in Range of 2.3% for people whose glucose management indicator (GMI) was >8% and an increase of 5% Time in Range for people whose GMI was >9.5%.
In both groups, people did not experience any increase in Time Below Range2 (hypoglycemia) during the study period.
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).
Medtronic says that 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.
In the United States, Medtronic Extended infusion set is limited to investigational use only and not approved for sale. In Europe it is already CE marked.