The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petach Tikva, Israel.
Pediatr Diabetes. 2013 May;14(3):196-202. doi: 10.1111/pedi.12012. Epub 2013 Jan 4.
To assess the efficacy and safety of insulin detemir administered once vs. twice daily in children and adolescents with type 1 diabetes mellitus.
In this prospective, open-label, treat-to-target study, 37 patients [mean age 12.7 ± 3 yr; diabetes duration 4.2 ± 3 yr, hemoglobin A1c (HbA1c) 8.8 ± 0.8%] were scheduled to receive insulin detemir once daily before breakfast, with pre-meal insulin aspart, for 16-20 wk. Detemir dose titration algorithm was based on age-related target fasting blood glucose levels during 4-8 wk. Patients achieving target range continued on once-daily detemir (Group A) if up-titration could not be done due to hypoglycemia patients were switched to twice-daily detemir (Group B).
Nineteen (51%) patients continued with once-daily detemir. HbA1c decreased significantly in both groups (A: -0.7%, p = 0.02; B: -0.8%, p = 0.004), without a significant difference between groups. The frequency of nocturnal hypoglycemic events/week decreased in both groups but a significant change was found only in Group A (10.9-2.7, p < 0.05 vs. 8.7-5.8, NS), with no change in frequency of severe hypoglycemic episodes in either group. No significant differences were found between and within groups for body mass index-standard deviation score, insulin requirement or treatment satisfaction. Group B patients were significantly younger than Group A patients (11.5 ± 2.3 vs.13.8 ± 3.2 yr, p = 0.01), with a higher percentage in active puberty (50 vs. 11%, p = 0.003).
Since twice-daily determir showed no clinical advantage over once-daily detemir, it appears reasonable to commence all children on once-daily detemir, taking into consideration that younger children and those in active puberty may require twice-daily therapy (ClinicalTrials.gov number, NCT00542399).
评估在儿童和青少年 1 型糖尿病患者中，每日一次给予地特胰岛素与每日两次给予地特胰岛素的疗效和安全性。
在这项前瞻性、开放标签、以目标为导向的研究中，37 例患者[平均年龄 12.7±3 岁；糖尿病病程 4.2±3 年，糖化血红蛋白（HbA1c）8.8±0.8%]接受早餐前每日一次地特胰岛素治疗，同时给予门冬胰岛素。16-20 周后，根据 4-8 周时与年龄相关的目标空腹血糖水平调整地特胰岛素剂量。如果由于低血糖不能进行上调，则达到目标范围的患者继续接受每日一次地特胰岛素治疗（A 组）；如果患者切换为每日两次地特胰岛素（B 组）。
19 例（51%）患者继续接受每日一次地特胰岛素治疗。两组患者的 HbA1c 均显著下降（A 组：-0.7%，p=0.02；B 组：-0.8%，p=0.004），但两组之间无显著差异。两组患者夜间低血糖事件/周的频率均降低，但仅在 A 组中发现显著变化（10.9-2.7，p<0.05 与 8.7-5.8，NS），两组重度低血糖发作频率均无变化。两组之间和组内的体重指数标准差评分、胰岛素需求或治疗满意度均无显著差异。B 组患者明显比 A 组患者年轻（11.5±2.3 岁与 13.8±3.2 岁，p=0.01），青春期活跃的比例更高（50%与 11%，p=0.003）。
由于每日两次地特胰岛素与每日一次地特胰岛素相比没有临床优势，因此对于所有儿童患者，考虑到年幼的儿童和青春期活跃的儿童可能需要每日两次治疗，开始时使用每日一次地特胰岛素似乎是合理的（ClinicalTrials.gov 编号：NCT00542399）。
