Division of Endocrinology and Diabetes, Medical Faculty, RWTH Aachen University, Aachen, Germany.
Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany; German Center for Diabetes Research, Neuherberg, Germany.
Lancet Diabetes Endocrinol. 2023 May;11(5):314-323. doi: 10.1016/S2213-8587(23)00061-X. Epub 2023 Mar 30.
The effect of continuous glucose monitoring on the risk of severe hypoglycaemia and ketoacidosis in patients with diabetes is unclear. We investigated whether rates of acute diabetes complications are lower with continuous glucose monitoring, compared with blood glucose monitoring, and which metrics predict its risk in young patients with type 1 diabetes.
In this population-based cohort study, patients were identified from 511 diabetes centres across Austria, Germany, Luxembourg, and Switzerland participating in the Diabetes Prospective Follow-up initiative. We included people with type 1 diabetes aged 1·5-25·0 years, with a diabetes duration of more than 1 year, who had been treated between Jan 1, 2014, and June 30, 2021, and had an observation time of longer than 120 days in the most recent treatment year. Severe hypoglycaemia and ketoacidosis rates during the most recent treatment year were examined in people using continuous glucose monitoring and in those using blood glucose monitoring. Adjustments of statistical models included age, sex, diabetes duration, migration background, insulin therapy (pump or injections), and treatment period. Rates of severe hypoglycaemia and diabetic ketoacidosis were evaluated by several continuous glucose monitoring metrics, including percentage of time below target glucose range (<3·9 mmol/L), glycaemic variability (measured as the coefficient of variation), and mean sensor glucose.
Of 32 117 people with type 1 diabetes (median age 16·8 years [IQR 13·3-18·1], 17 056 [53·1%] males), 10 883 used continuous glucose monitoring (median 289 days per year), and 21 234 used blood glucose monitoring. People using continuous glucose monitoring had lower rates of severe hypoglycaemia than those using blood glucose monitoring (6·74 [95% CI 5·90-7·69] per 100 patient-years vs 8·84 [8·09-9·66] per 100 patient-years; incidence rate ratio 0·76 [95% CI 0·64-0·91]; p=0·0017) and diabetic ketoacidosis (3·72 [3·32-4·18] per 100 patient-years vs 7·29 [6·83-7·78] per 100 patient-years; 0·51 [0·44-0·59]; p<0·0001). Severe hypoglycaemia rates increased with percentage of time below target glucose range (incidence rate ratio 1·69 [95% CI 1·18-2·43]; p=0·0024, for 4·0-7·9% vs <4·0% and 2·38 [1·51-3·76]; p<0·0001, for ≥8·0% vs <4·0%) and glycaemic variability (coefficient of variation ≥36% vs <36%; incidence rate ratio 1·52 [95% CI 1·06-2·17]; p=0·022). Diabetic ketoacidosis rates increased with mean sensor glucose (incidence rate ratio 1·77 [95% CI 0·89-3·51], p=0·13, for 8·3-9·9 mmol/L vs <8·3 mmol/L; 3·56 [1·83-6·93], p<0·0001, for 10·0-11·6 mmol/L vs <8·3 mmol/L; and 8·66 [4·48-16·75], p<0·0001, for ≥11·7 mmol/L vs <8·3 mmol/L).
These findings provide evidence that continuous glucose monitoring can reduce severe hypoglycaemia and ketoacidosis risk in young people with type 1 diabetes on insulin therapy. Continuous glucose monitoring metrics might help to identify those at risk for acute diabetes complications.
German Center for Diabetes Research, German Federal Ministry of Education and Research, German Diabetes Association, and Robert Koch Institute.
连续血糖监测对糖尿病患者严重低血糖和酮症酸中毒风险的影响尚不清楚。我们研究了与血糖监测相比，连续血糖监测是否会降低急性糖尿病并发症的发生率，以及哪些指标可以预测年轻 1 型糖尿病患者的风险。
在这项基于人群的队列研究中，我们从参与糖尿病前瞻性随访倡议的奥地利、德国、卢森堡和瑞士的 511 个糖尿病中心确定了患者。我们纳入了年龄在 1.5-25.0 岁、糖尿病病程超过 1 年、在最近的治疗年中有超过 120 天的观察时间、接受胰岛素治疗（泵或注射）的 1 型糖尿病患者。在最近的治疗年中，使用连续血糖监测和血糖监测的患者的严重低血糖和酮症酸中毒发生率进行了检查。统计模型的调整包括年龄、性别、糖尿病病程、移民背景、胰岛素治疗（泵或注射）和治疗期。通过几个连续血糖监测指标评估严重低血糖和糖尿病酮症酸中毒的发生率，包括目标血糖范围以下时间的百分比（<3.9 mmol/L）、血糖变异性（以变异系数衡量）和传感器平均血糖。
在 32117 名 1 型糖尿病患者中（中位数年龄 16.8 岁[IQR 13.3-18.1]，17056 名[53.1%]男性），10883 名使用连续血糖监测（中位数每年 289 天），21234 名使用血糖监测。与使用血糖监测的患者相比，使用连续血糖监测的患者严重低血糖发生率较低（每 100 患者年 6.74[95%CI 5.90-7.69]与 8.84[8.09-9.66]；发病率比 0.76[95%CI 0.64-0.91]；p=0.0017）和糖尿病酮症酸中毒（每 100 患者年 3.72[3.32-4.18]与 7.29[6.83-7.78]；0.51[0.44-0.59]；p<0.0001）。严重低血糖发生率随目标血糖范围以下时间的百分比增加而升高（发病率比 1.69[95%CI 1.18-2.43]；p=0.0024，4.0-7.9%比<4.0%和 2.38[1.51-3.76]；p<0.0001，≥8.0%比<4.0%）和血糖变异性（变异系数≥36%比<36%；发病率比 1.52[95%CI 1.06-2.17]；p=0.022）。糖尿病酮症酸中毒发生率随传感器平均血糖升高而升高（发病率比 1.77[95%CI 0.89-3.51]；p=0.13，8.3-9.9 mmol/L 比<8.3 mmol/L；3.56[1.83-6.93]；p<0.0001，10.0-11.6 mmol/L 比<8.3 mmol/L；8.66[4.48-16.75]；p<0.0001，≥11.7 mmol/L 比<8.3 mmol/L）。
这些发现提供了证据表明，连续血糖监测可以降低年轻胰岛素治疗的 1 型糖尿病患者的严重低血糖和酮症酸中毒风险。连续血糖监测指标可能有助于识别急性糖尿病并发症风险高的患者。
德国糖尿病研究中心、德国联邦教育与研究部、德国糖尿病协会和罗伯特·科赫研究所。
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