Clinical Research Unit, Paris Descartes, Assistance Publique-Hôpitaux de Paris, Necker University Hospital, Paris, France.
French Clinical Research Group in Adolescent Medicine and Health, Paris, France.
PLoS One. 2021 Mar 15;16(3):e0248549. doi: 10.1371/journal.pone.0248549. eCollection 2021.
Among adolescents with type 1 diabetes, some experience great difficulties with treatment adherence, putting them at high risk of complications. We assessed the effect of text messaging (Short Messaging Service [SMS]) on glycemic control.
A two-arm open label randomized controlled trial enrolled adolescents with type 1 diabetes aged 12-21 years with baseline HbA1c ≥ 69 mmol/mol (8.5%). The intervention group received daily SMS reminders at self-selected times about insulin injections while the control group received standard of care. The patients allocated to the control group were not aware of the intervention.
92 patients were randomized, 45 in the SMS arm and 47 in the control arm. After 6 months, median HbA1c level was significantly lower in the intervention arm: 73 mmol/mol (8.8%) in the SMS arm and 83 mmol/mol (9.7%) in the control arm in the intent-to-treat analysis (P = 0.03) but no longer in the per protocol analysis (P = 0.65). When we consider the proportions of patients whose HbA1c level decreased by at least 1% between baseline and 6 months, we find a significant difference among patients whose baseline HbA1c was ≥ 80 mmol/mol (9.5%) (n = 56): 60% in the SMS arm and 30.6% in the control arm had lowered their HbA1c level (P = 0.03) in the intent-to-treat analysis but not in the per-protocol analysis (P = 0.50). Patients in the SMS arm reported high satisfaction with the intervention.
While there is a trend to lower HbA1c in the intervention group, no firm conclusions can yet be drawn. Further studies are needed to address methodological issues as we believe these interventions can support behavior change among adolescents with poorly controlled type 1 diabetes. ClinicalTrials.gov identifier: NCT02230137.
在患有 1 型糖尿病的青少年中，有些人在治疗依从性方面存在很大困难，使他们处于并发症高发的风险之中。我们评估了短信（短消息服务）对血糖控制的影响。
一项双臂开放标签随机对照试验纳入了年龄在 12-21 岁之间、基线糖化血红蛋白（HbA1c）≥69mmol/mol（8.5%）的 1 型糖尿病青少年。干预组在自我选择的时间接受每日短信提醒关于胰岛素注射，而对照组则接受常规护理。分配到对照组的患者并不知道干预措施。
92 名患者被随机分组，短信组 45 名，对照组 47 名。6 个月后，干预组的中位 HbA1c 水平明显较低：短信组为 73mmol/mol（8.8%），对照组为 83mmol/mol（9.7%），意向治疗分析（P=0.03），但在方案分析中不再显著（P=0.65）。当我们考虑基线和 6 个月之间 HbA1c 水平降低至少 1%的患者比例时，我们发现基线 HbA1c 水平≥80mmol/mol（9.5%）的患者（n=56）之间存在显著差异：短信组 60%，对照组 30.6%，HbA1c 水平降低（P=0.03），意向治疗分析中，但在方案分析中没有（P=0.50）。短信组的患者对干预措施的满意度较高。
尽管干预组有降低 HbA1c 的趋势，但目前还不能得出明确的结论。需要进一步研究来解决方法学问题，因为我们相信这些干预措施可以支持血糖控制不佳的 1 型糖尿病青少年的行为改变。临床试验编号：NCT02230137。
