Lajara Rosemarie, Fetchick Dianne A, Morris Tracy L, Nikkel Carla
Diabetes America, Plano, TX, USA.
Diabetes America, San Antonio, TX, USA.
Diabetes Ther. 2015 Dec;6(4):531-545. doi: 10.1007/s13300-015-0138-7. Epub 2015 Oct 15.
Tight glycemic control and timely treatment can improve outcomes in patients with diabetes yet many remain sub-optimally controlled. The objective of the current study was to evaluate the effect of switching patients with sub-optimally controlled diabetes to the V-Go (Valeritas Inc., Bridgewater, NJ, USA) Disposable Insulin Delivery device.
A retrospective analysis of electronic medical records was conducted to assess patients with sub-optimal glycemic control defined as a glycated hemoglobin (HbA1c) >7%, switched to V-Go. Blood glucose control defined as change from baseline in HbA1c, prescribed insulin doses, body weight, concomitant anti-hyperglycemic agents, and reported hypoglycemia were collected prior to switching to V-Go and during V-Go use.
Two-hundred and four patients were evaluated during the study period. Overall, there was a significant decrease in HbA1c after switching to V-Go at the 14- and 27-week follow-up visits. The least-squares mean (LSM) change in HbA1c (95% confidence interval) from baseline to 14 weeks was -1.53% (-1.69% to -1.37%; P < 0.001), and from baseline to 27 weeks was -1.79% (-1.97% to -1.61%; P < 0.001). Significant reductions in mean HbA1c were achieved at both visits in all patient subsets: Patients with type 2 and type 1/latent autoimmune diabetes in adults (LADA); patients using insulin at baseline and patients naïve to insulin at baseline. Patients administering insulin at baseline required significantly less insulin on V-Go (86-99 LSM units/day at baseline to 58 LSM units/day at 27 weeks; P < 0.001). Across all patients, reported hypoglycemic events were no more frequent on V-Go than on previous therapy.
V-Go is safe and effective in patients with sub-optimally controlled diabetes requiring insulin therapy. Glycemic control improved significantly, less insulin was required, and hypoglycemic events were similar after patients switched to insulin delivery by V-Go.
Valeritas, Inc.
严格的血糖控制和及时治疗可改善糖尿病患者的预后,但仍有许多患者的血糖控制未达最佳水平。本研究的目的是评估将血糖控制欠佳的糖尿病患者改用V-Go(美国新泽西州布里奇沃特市Valeritas公司生产)一次性胰岛素输注装置的效果。
对电子病历进行回顾性分析,以评估血糖控制欠佳(糖化血红蛋白[HbA1c]>7%)且改用V-Go的患者。收集改用V-Go之前及使用V-Go期间血糖控制情况的数据,包括HbA1c相对于基线的变化、胰岛素处方剂量、体重、同时使用的降糖药物以及报告的低血糖情况。
在研究期间对204例患者进行了评估。总体而言,在14周和27周的随访中,改用V-Go后HbA1c显著降低。HbA1c从基线到14周的最小二乘均值(LSM)变化(95%置信区间)为-1.53%(-1.69%至-1.37%;P<0.001),从基线到27周为-1.79%(-1.97%至-1.61%;P<0.001)。在所有患者亚组的两次随访中,HbA1c均值均显著降低:2型糖尿病患者以及成人隐匿性自身免疫性糖尿病(LADA)患者;基线时使用胰岛素的患者和基线时未使用过胰岛素的患者。基线时使用胰岛素的患者在使用V-Go时所需胰岛素显著减少(基线时为86 - 99 LSM单位/天,27周时为58 LSM单位/天;P<0.001)。在所有患者中,报告的低血糖事件在使用V-Go时并不比之前的治疗更频繁。
对于血糖控制欠佳且需要胰岛素治疗的糖尿病患者,V-Go安全有效。改用V-Go进行胰岛素输注后,血糖控制显著改善,所需胰岛素减少,低血糖事件发生率相似。
Valeritas公司