Pediatric Endocrinology and Diabetes Division, Department of Pediatrics, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, India.
Department of Endocrinology, Postgraduate Institute of Medical Education and Research (PGIMER), Sector 12, Chandigarh, India.
Sci Rep. 2019 Apr 16;9(1):6120. doi: 10.1038/s41598-019-42555-6.
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.
频繁的自我血糖监测（SMBG）是 T1DM 患者胰岛素剂量调整中唯一准确的方法。专业连续血糖监测（p-CGM）是对 5-7 天内血糖趋势的盲法记录，可以帮助医生指导胰岛素滴定。本研究旨在评估基于 p-CGM+SMBG 的胰岛素剂量调整在改善血糖控制方面的疗效，与单独 SMBG 相比。我们在至少有 6 个月 T1DM 病史的儿童（2-10 岁）中进行了一项开放标签、平行设计、随机对照试验。干预组的受试者使用 iPRO 2™ Professional CGM（美敦力，美国）进行 3-5 天的 p-CGM 监测，并结合常规 SMBG。p-CGM 的数据由医生进行分析，并结合 SMBG 在接下来的 3 个月内指导胰岛素滴定。对照组仅记录 SMBG 数据以调整胰岛素剂量。主要结局是干预后 3 个月 HbA1c 的变化。共有 68 名符合条件的儿童被随机分组，每组 34 名。干预组 30 名儿童和对照组 33 名儿童完成了研究并进行了分析。结果发现，干预组 HbA1c 的单位变化减少更多，低血糖记录的百分比和每天总胰岛素需求也减少更多，在 3 个月的随访后。但是，除了每天每公斤体重的胰岛素单位（p=0.014）外，差异无统计学意义。在基线 HbA1c>7.5%的儿童亚组分析中，HbA1c 平均下降 1.27%（p=0.045），差异有统计学意义。p-CGM 无主要不良事件。我们得出结论，在 SMBG 基础上添加 p-CGM 可能有助于更有效地调整胰岛素剂量，尤其是在基线 HbA1c 较高的儿童中。
