Pediatrics and Neonatology departement , Yasminette Ben Arous , Tunisia. University El Manar , Faculty of Medecine of Tunis.
Functional Explorations Department and Sleep Respiratory Pathologies Center for Children at Robert Debré Hospital. University El Manar , Faculty of Medecine of Tunis.
Tunis Med. 2024 Aug 5;102(8):452-456. doi: 10.62438/tunismed.v102i8.4435.
there is a lack of research evaluating the impact of therapeutic switching from human insulin to analogues, particularly in paediatric populations from low- and middle-income countries.
The study aimed to retrospectively assess the effectiveness and safety of transitioning from human insulin to insulin analogs in Tunisian children with diabetes.
This retrospective descriptive study included children with type 1 diabetes who changed their insulin therapy protocol after at least one year of treatment with human insulin. Clinical, therapeutic, and glycaemic homeostasis parameters were assessed following the transition from human insulin (NPH + rapid-acting insulin) to the Basal-Bolus insulin analog- protocol.
The study included 60 patients. Following the switch, all patients showed a significant reduction in mean fasting blood glucose levels (11.11 mmol/l vs. 8.62 mmol/l; p=0.024). Glycated haemoglobin A1C levels decreased notably in children who adhered to their diet (from 9.93% to 8.38%; p=0.06) and/or engaged in regular physical activity (from 10.40% to 8.61%; p=0.043). The average number of hypoglycemic events per year decreased from 4.03 events/year to 2.36 events/year (p=0.006), along with a decrease in the rate of patients hospitalized for acid-ketotic decompensation (from 27% to 10%; p=0.001). Financial constraints led to 82% of patients reusing microfine needles ≥2 times per day, and 12% were compelled to revert to the initial insulin therapy protocol due to a lack of access to self-financed microfine needles or discontinued social coverage.
Although insulin analogues offer clear benefits, their use poses challenges as a therapeutic choice for children with diabetes in low- to middle-income countries. These challenges hinder the achievement of optimal glycemic control goals.
目前缺乏评估从人胰岛素转换为类似物治疗效果的研究,特别是在中低收入国家的儿科人群中。
本研究旨在回顾性评估在突尼斯儿童糖尿病患者中从人胰岛素转换为胰岛素类似物的有效性和安全性。
本回顾性描述性研究纳入了至少接受人胰岛素治疗 1 年以上并改变胰岛素治疗方案的 1 型糖尿病儿童患者。在从人胰岛素(NPH+速效胰岛素)转换为基础-餐时胰岛素类似物方案后,评估临床、治疗和血糖稳态参数。
本研究共纳入 60 例患者。转换后,所有患者的空腹血糖水平均显著降低(从 11.11mmol/L 降至 8.62mmol/L;p=0.024)。饮食依从性较好(从 9.93%降至 8.38%;p=0.06)和/或定期进行体育活动(从 10.40%降至 8.61%;p=0.043)的儿童患者糖化血红蛋白 A1C 水平显著下降。每年低血糖事件的平均次数从 4.03 次/年减少到 2.36 次/年(p=0.006),因酮症酸中毒恶化而住院的患者比例也从 27%下降到 10%(p=0.001)。由于经济困难,82%的患者每天重复使用微针 2 次以上,12%的患者因无法获得自费微针或停止社会医疗保险而被迫重新使用初始胰岛素治疗方案。
尽管胰岛素类似物具有明显优势,但作为中低收入国家儿童糖尿病患者的治疗选择,它们的使用仍面临挑战。这些挑战阻碍了实现最佳血糖控制目标。