Diabetes Center, First Department of Propaedeutic Internal Medicine, Medical School, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Diabetes Center, First Department of Internal Medicine, Medical School, AHEPA Hospital, Aristotle University, Thessaloniki, Greece.
Hormones (Athens). 2019 Dec;18(4):443-450. doi: 10.1007/s42000-019-00153-1. Epub 2019 Nov 13.
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.
评估实时连续血糖监测(RT-CGM)系统在血糖控制不佳的 1 型糖尿病(T1D)成人患者中与胰岛素泵治疗联合应用 3 个月的疗效。
这是一项前瞻性、多中心、非随机、上市后研究。共有 43 名接受胰岛素泵治疗且血糖控制不佳(HbA1c>7.0%)的 T1D 成年患者参与了该研究。主要终点是从基线 HbA1c 水平的变化。次要目标是评估 RT-CGM 系统对血糖变异性、每日胰岛素需求以及低血糖和酮症酸中毒事件发生频率的影响。
3 个月时,HbA1c 从基线的 8.0(7.6,8.7)%降至 7.1(6.7,8.0)%(p<0.001)。19 名患者(44.2%)治疗后 HbA1c 水平≤7%。使用 RT-CGM 系统后,平均总日胰岛素需求量以及平均每日胰岛素推注次数均显著增加。RT-CGM 使用的第一周和最后一周记录的低血糖事件数量没有差异,而在 3 个月的随访期间,没有发生严重低血糖事件、酮症酸中毒事件或与糖尿病相关的住院治疗。
在血糖控制不佳的 T1D 患者中,将 RT-CGM 系统与胰岛素泵治疗联合应用 3 个月可改善 HbA1c 水平,而不会增加低血糖事件的风险。