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Clinical efficacy of Professional Continuous Glucose Monitoring in improving glycemic control among children with Type 1 Diabetes Mellitus: An Open-label Randomized Control Trial
Scientific Reports ( IF 3.8 ) Pub Date : 2019-04-16 , DOI: 10.1038/s41598-019-42555-6
K. V. Raviteja , Rakesh Kumar , Devi Dayal , Naresh Sachdeva

Frequent self-monitoring of blood glucose (SMBG) is the only accurate method available for insulin dose titration in patients with T1DM. Professional continuous glucose monitoring (p-CGM) is blinded recording of glucose trends over 5–7 days and helps physicians to guide insulin titration to patient. This study was planned to assess efficacy of insulin dose adjustments, based on p-CGM plus SMBG in improving glycemic control compared to SMBG alone. We did an open-label, parallel design, randomized control trial among children (2–10 years) having T1DM for at least 6 months. Subjects in the intervention group were placed on p-CGM (iPRO 2™ Professional CGM, Medtronic, USA) for 3–5 days along with regular SMBG. Data from p-CGM was analyzed by physician and used to guide insulin titration along with SMBG over following 3 months. Control group had only SMBG records for titrating insulin doses. Primary outcome was change in HbA1c 3 months after intervention. A total of 68 eligible children were randomized, 34 each to either arms. Thirty children in intervention group and 33 in control group completed the study and were analyzed. It was found that there was more decreased unit change in HbA1c, percentage of low sugar records and total insulin requirement per day, after 3 months follow-up, in intervention group. However, difference was not significant except for total insulin Units/kg/day (p = 0.014). In sub-group analysis of children with baseline HbA1c >7.5%, there was a significant mean fall of HbA1c by 1.27% (p = 0.045). There were no major adverse events associated with p-CGM. We conclude that addition of p-CGM along with SMBG may help in adjusting insulin dose more effectively especially in children with higher baseline HbA1c.



中文翻译:

专业连续血糖监测改善1型糖尿病儿童血糖控制的临床疗效:一项开放标签的随机对照试验

频繁的自我血糖监测(SMBG)是可用于T1DM患者胰岛素滴定的唯一准确方法。专业的连续血糖监测(p-CGM)可以盲目记录5-7天的血糖趋势,并帮助医生指导患者进行胰岛素滴定。与单独使用SMBG相比,本研究计划基于p-CGM加SMBG评估胰岛素剂量调整的效果,以改善血糖控制。我们对患有T1DM至少6个月的儿童(2-10岁)进行了开放标签,平行设计,随机对照试验。干预组中的受试者将它们与常规SMBG一起放置在p-CGM(iPRO 2™Professional CGM,美国Medtronic,美国)上3到5天。医生对p-CGM的数据进行了分析,并在接下来的3个月中用于指导胰岛素和SMBG的滴定。控制组仅具有SMBG记录来确定胰岛素剂量。主要结果是干预后3个月HbA1c发生变化。共有68名符合条件的儿童被随机分配,每组各有34名儿童。干预组的30名儿童和对照组的33名儿童完成了研究并进行了分析。在干预组中,随访3个月后发现,每天的HbA1c单位变化,低糖记录百分比和每天总胰岛素需求量下降的幅度更大。但是,除总胰岛素单位/千克/天外,差异无统计学意义(p = 0.014)。在基线HbA1c> 7.5%的儿童的亚组分析中,HbA1c的平均下降显着为1.27%(p = 0.045)。没有与p-CGM相关的重大不良事件。

更新日期:2019-04-16
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