LAUSR

To assess the efficacy of a real-time continuous glucose monitoring (RT–CGM) system added to insulin pump therapy for 3 months, in sub-optimally controlled adults with type 1 diabetes mellitus (T1D). This was a prospective, multicenter, non-randomized, post-market release study. A total of 43 adult patients with T1D on insulin pump therapy and inadequate glycemic control (HbA1c > 7.0%) participated in the study. The primary endpoint was the change from baseline HbA1c levels. Secondary objectives were to evaluate the impact of the RT–CGM system on glucose variability, daily insulin requirements, and the frequency of hypoglycemic and ketoacidosis events. At 3 months, the baseline HbA1c values decreased from 8.0 (7.6, 8.7) to 7.1 (6.7, 8.0) % (p < 0.001). Nineteen participants (44.2%) had a posttreatment HbA1c level ≤ 7%. Average total daily insulin requirements, as well as the average number of insulin boluses per day, increased significantly after the use of the RT–CGM system. The number of hypoglycemic events recorded did not differ between the first week and last week of RT–CGM usage, while no severe hypoglycemic episodes, ketoacidosis events, or hospitalizations related to diabetes occurred during the 3-month follow-up period. Addition of a RT–CGM system to insulin pump therapy for 3 months in inadequately controlled patients with T1D resulted in improved HbA1c levels, without increasing the risk of hypoglycemic events.