Abstract：
BACKGROUND: 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.
OBJECTIVE: The study aimed to retrospectively assess the effectiveness and safety of transitioning from human insulin to insulin analogs in Tunisian children with diabetes.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: The study aimed to retrospectively assess the effectiveness and safety of transitioning from human insulin to insulin analogs in Tunisian children with diabetes.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：缺乏评估从人胰岛素到类似物的治疗转换的影响的研究，特别是在低收入和中等收入国家的儿科人群中。
目的：本研究旨在回顾性评估突尼斯糖尿病儿童从人胰岛素过渡到胰岛素类似物的有效性和安全性。
方法：这项回顾性描述性研究包括1型糖尿病儿童，他们在接受人胰岛素治疗至少一年后改变了他们的胰岛素治疗方案。临床,治疗性的,在从人胰岛素(NPH+速效胰岛素)过渡到基础-Bolus胰岛素类似物方案之后,评估血糖稳态参数。
结果：该研究包括60名患者。跟着开关，所有患者的平均空腹血糖水平显着降低（11.11mmol/lvs.8.62mmol/l；p=0.024）。在坚持饮食（从9.93％到8.38％；p=0.06）和/或进行定期体育锻炼（从10.40％到8.61％；p=0.043）的儿童中，糖化血红蛋白A1C水平显着降低。每年低血糖事件的平均数量从4.03事件/年下降到2.36事件/年（p=0.006），同时,患者因酸酮症失代偿住院率也有所下降(从27%降至10%;p=0.001).资金紧张导致82%的患者每天重复使用细针≥2次，12%的患者由于无法获得自费的超细针头或社会覆盖中断而被迫恢复到最初的胰岛素治疗方案.
结论：尽管胰岛素类似物具有明显的益处，它们作为中低收入国家糖尿病儿童的治疗选择带来了挑战.这些挑战阻碍了最佳血糖控制目标的实现。
目的：本研究旨在回顾性评估突尼斯糖尿病儿童从人胰岛素过渡到胰岛素类似物的有效性和安全性。
方法：这项回顾性描述性研究包括1型糖尿病儿童，他们在接受人胰岛素治疗至少一年后改变了他们的胰岛素治疗方案。临床,治疗性的,在从人胰岛素(NPH+速效胰岛素)过渡到基础-Bolus胰岛素类似物方案之后,评估血糖稳态参数。
结果：该研究包括60名患者。跟着开关，所有患者的平均空腹血糖水平显着降低（11.11mmol/lvs.8.62mmol/l；p=0.024）。在坚持饮食（从9.93％到8.38％；p=0.06）和/或进行定期体育锻炼（从10.40％到8.61％；p=0.043）的儿童中，糖化血红蛋白A1C水平显着降低。每年低血糖事件的平均数量从4.03事件/年下降到2.36事件/年（p=0.006），同时,患者因酸酮症失代偿住院率也有所下降(从27%降至10%;p=0.001).资金紧张导致82%的患者每天重复使用细针≥2次，12%的患者由于无法获得自费的超细针头或社会覆盖中断而被迫恢复到最初的胰岛素治疗方案.
结论：尽管胰岛素类似物具有明显的益处，它们作为中低收入国家糖尿病儿童的治疗选择带来了挑战.这些挑战阻碍了最佳血糖控制目标的实现。
