Division of Pediatric Endocrinology and Diabetology, Center of Child and Adolescent Medicine, Justus Liebig University, Giessen, Germany.
ZIBMT, Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany; German Center for Diabetes Research, Munich, Germany.
Lancet Child Adolesc Health. 2021 Jan;5(1):17-25. doi: 10.1016/S2352-4642(20)30339-4. Epub 2020 Nov 27.
Although continuous subcutaneous insulin infusion therapy (ie, insulin pump therapy) is associated with improved metabolic control compared with multiple daily insulin injections in children with type 1 diabetes, it is unclear when it is best to start it after diagnosis. In this study, we aimed to compare the outcomes between early and delayed start of insulin pump therapy in young patients with type 1 diabetes.
We based the current study on data from the multicentre, prospective diabetes follow-up registry (ie, Diabetes-Patienten-Verlaufsdokumentation [DPV]). The DPV registry comprises 501 diabetes centres from Germany, Austria, Switzerland, and Luxembourg. We included patients diagnosed with type 1 diabetes between 2004 and 2014, who were aged between 6 months and 15 years at the time of diagnosis, who had started insulin pump therapy either within the first 6 months (ie, the early treatment group) or in the second to third year (ie, the delayed treatment group) after diabetes diagnosis, and who were treated with insulin pump therapy for at least 1 year. The outcome parameters included the glycated haemoglobin (HbA) values, the cardiovascular risk profile, and rates of acute complications and diabetes-associated hospital admissions (ie, hospitalisation) during the most recent documented treatment year with insulin pump therapy. Statistical models were adjusted for age at diabetes diagnosis, year of diagnosis, sex, immigrant background, use of continuous glucose monitoring, centre size, and the German Index of Socioeconomic Deprivation 2012 terciles.
Our study sample comprised 8332 patients from 311 diabetes centres in Germany, Austria, Switzerland, and Luxembourg. The early treatment group consisted of 4004 (48·1%) of 8332 patients, and the delayed treatment group consisted of 4328 (51·9%). The median diabetes duration during follow-up was 6·7 years (IQR 5·1-8·7 in the early group; 5·0-8·7 in the delayed group) in both groups. Patients with early initiation of insulin pump therapy compared with those with delayed initiation of insulin pump therapy had significantly lower estimated mean HbA values (7·9% [95% CI 7·8-7·9] and 62·6 mmol/mol [95% CI 62·1-63·2] vs 8·0% [8·0-8·1] and 64·1 mmol/mol [63·6-64·6]; p=0·0006), and lower rates of hypoglycaemic coma (incidence risk ratio 0·44 [95% CI 0·24-0·79]; p=0·0064) and hospitalisation (0·86 [95% CI 0·78-0·94]; p=0·0016). A better cardiovascular risk profile was observed in patients with early initiation of insulin pump therapy than in those with delayed initiation: an estimated mean systolic blood pressure of 117·6 mm Hg (95% CI 117·2-117·9) versus 118·5 mm Hg (118·2-118·9), p=0·0007; and HDL cholesterol of 62·8 mg/dL (95% CI 62·2-63·5) versus 60·6 mg/dL (60·0-61·2), p<0·0001; however, diastolic blood pressure; concentrations of LDL cholesterol, non-HDL cholesterol, and triglycerides; and estimated body-mass index standard deviation scores during follow-up did not differ significantly between both groups.
Our findings provide evidence for improved clinical outcomes associated with the early initiation of insulin pump therapy in children with type 1 diabetes.
The German Center for Diabetes Research (Deutsches Zentrum für Diabetesforschung), German Robert Koch Institute, German Diabetes Association, and Diabetes Agenda 2010.
虽然连续皮下胰岛素输注疗法(即胰岛素泵疗法)与多次皮下胰岛素注射相比,可改善 1 型糖尿病患儿的代谢控制,但何时开始治疗仍不清楚。本研究旨在比较 1 型糖尿病患儿早期和延迟开始胰岛素泵治疗的结局。
我们基于多中心前瞻性糖尿病随访登记(即糖尿病患者随访记录)的数据进行了当前研究。该 DPV 登记处包括德国、奥地利、瑞士和卢森堡的 501 个糖尿病中心。我们纳入了 2004 年至 2014 年间诊断为 1 型糖尿病的患者,这些患者在诊断时年龄在 6 个月至 15 岁之间,在诊断后第 1 年内(即早期治疗组)或第 2 至第 3 年(即延迟治疗组)开始使用胰岛素泵治疗,并且使用胰岛素泵治疗至少 1 年。结局参数包括糖化血红蛋白(HbA)值、心血管风险状况以及最近接受胰岛素泵治疗的治疗年内急性并发症和与糖尿病相关的住院(即住院)发生率。统计模型调整了年龄、诊断年龄、性别、移民背景、连续血糖监测使用、中心规模和德国 2012 年社会剥夺指数三分位数。
我们的研究样本包括来自德国、奥地利、瑞士和卢森堡的 311 个糖尿病中心的 8332 名患者。早期治疗组包括 8332 名患者中的 4004 名(48.1%),而延迟治疗组包括 4328 名(51.9%)。两组的中位糖尿病病程随访时间为 6.7 年(早期组为 5.1-8.7,延迟组为 5.0-8.7)。与延迟开始胰岛素泵治疗相比,早期开始胰岛素泵治疗的患者 HbA 值估计均值明显较低(7.9%[95%CI 7.8-7.9]和 62.6mmol/mol[95%CI 62.1-63.2] vs 8.0%[8.0-8.1]和 64.1mmol/mol[63.6-64.6];p=0.0006),低血糖性昏迷发生率较低(发生率风险比 0.44[95%CI 0.24-0.79];p=0.0064)和住院率较低(0.86[95%CI 0.78-0.94];p=0.0016)。与延迟开始胰岛素泵治疗相比,早期开始胰岛素泵治疗的患者心血管风险状况更好:收缩压估计均值为 117.6mmHg(95%CI 117.2-117.9)vs 118.5mmHg(118.2-118.9),p=0.0007;和 HDL 胆固醇 62.8mg/dL(95%CI 62.2-63.5)vs 60.6mg/dL(60.0-61.2),p<0.0001;然而,两组在随访期间舒张压;LDL 胆固醇、非 HDL 胆固醇和甘油三酯浓度;和估计的身体质量指数标准差评分无显著差异。
我们的研究结果提供了证据,表明在 1 型糖尿病患儿中早期开始胰岛素泵治疗可改善临床结局。
德国糖尿病研究中心(Deutsches Zentrum für Diabetesforschung)、德国罗伯特·科赫研究所(German Robert Koch Institute)、德国糖尿病协会(German Diabetes Association)和 2010 年糖尿病议程(Diabetes Agenda 2010)。