Fox Larry A, Balkman Emilie, Englert Kim, Hossain Jobayer, Mauras Nelly
Division of Endocrinology, Nemours Children's Health System, Jacksonville, Florida.
Biostatistics Core, Alfred I. duPont Hospital for Children, Wilmington, Delaware.
Pediatr Diabetes. 2017 Jun;18(4):271-276. doi: 10.1111/pedi.12404. Epub 2016 Jul 20.
This study explored the safety of using real-time sensor glucose (SG) data for treatment decisions in adolescents with poorly controlled type 1 diabetes.
Ten adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical research center and a continuous glucose sensor was inserted. Plasma glucose was measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. Starting at dinner, SG rather than YSI was used for treatment decisions unless YSI was <70 mg/dL (<3.9 mmol/L) or specific criteria indicating SG and YSI were very discordant were met. Participants were discharged after lunch the next day.
Ten participants (seven males; 15.2-17.8 year old) completed the study. The range of differences between high glucose correction doses using SG vs YSI for calculations was -2 (SG < YSI dose) to +1 (SG > YSI dose); this difference was two units in only 2 of 23 correction doses given (all SG < YSI dose). There were five episodes of mild hypoglycemia in two patients, two of which occurred after using SG for dose calculations. There was no severe hypoglycemia and no YSI glucose >350 mg/dL (19.4 mmol/L). Mean (±SE) pre- and postmeal YSI glucose were 163 ± 11 and 183 ± 12 mg/dL (9.1 ± 0.6 and 10.2 ± 0.7 mmol/L), respectively.
Use of real-time continuous glucose monitoring for treatment decisions was safe and did not result in significant over- or undertreatment. Use of SG for treatment decisions under supervised inpatient conditions is a suitable alternative to repeated fingerstick glucose monitoring. Outpatient studies using SG in real-time are needed.
本研究探讨了在1型糖尿病控制不佳的青少年中使用实时传感器血糖(SG)数据进行治疗决策的安全性。
10名1型糖尿病青少年,胰岛素泵治疗下糖化血红蛋白(HbA1c)≥9%,入住临床研究中心并插入连续血糖传感器。使用黄泉仪器公司(YSI)的葡萄糖分析仪至少每小时测量一次血浆葡萄糖。从晚餐开始,除非YSI测得的血糖<70mg/dL(<3.9mmol/L)或满足表明SG与YSI数据差异极大的特定标准,否则使用SG而非YSI数据进行治疗决策。参与者于次日午餐后出院。
10名参与者(7名男性;年龄15.2 - 17.8岁)完成了研究。使用SG与YSI计算高血糖校正剂量时的差异范围为-2(SG剂量<YSI剂量)至+1(SG剂量>YSI剂量);在23次校正剂量中,只有2次差异为两个单位(均为SG剂量<YSI剂量)。两名患者出现了5次轻度低血糖事件,其中2次发生在使用SG进行剂量计算之后。未发生严重低血糖事件,且YSI测得的血糖均未>350mg/dL(19.4mmol/L)。餐前和餐后YSI测得的血糖平均值(±标准误)分别为163±11和183±12mg/dL(9.1±0.6和10.2±0.7mmol/L)。
使用实时连续血糖监测进行治疗决策是安全的,且不会导致显著的治疗过度或不足。在住院监督条件下使用SG进行治疗决策是重复指尖血糖监测的合适替代方法。需要开展使用SG进行实时门诊研究。