de Valk Harold W, Feher Michael, Hansen Troels Krarup, Jendle Johan, Koefoed Mette Marie, Rizi Ehsan Parvaresh, Zimmermann Esther, Fadini Gian Paolo
Department of Internal Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.
Beta Cell Diabetes Centre, Chelsea and Westminster Hospital, London, UK.
Diabetes Ther. 2020 Sep;11(9):2159-2167. doi: 10.1007/s13300-020-00875-1. Epub 2020 Jul 14.
Hypoglycaemia is a common side effect of insulin therapy; low or high glycated haemoglobin (HbA) levels, history of hypoglycaemia or long diabetes duration are known modifiers of hypoglycaemia risk. In randomised clinical trials, lower rates of hypoglycaemia have been observed with the new-generation insulin analogue, long-acting insulin degludec, compared with other basal insulins.
The ReFLeCT study was a prospective observational study over 12 months. Patient-reported diary data on hypoglycaemia were collected from patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) who were switching from other basal insulins to insulin degludec (degludec) at their physician's discretion in routine clinical care. Two secondary analyses were undertaken to investigate the change in number of hypoglycaemic events: a post hoc analysis using the updated American Diabetes Association (ADA) level 1, 2 and 3 hypoglycaemia definitions, and a pre-specified analysis using patient characteristics (baseline HbA, diabetes duration, and physician's rationale for initiating degludec).
Switching to degludec was associated with significantly fewer hypoglycaemic events for all definitions in T1D, and level 1 and 2 in T2D (too few level 3 events for statistical comparison). Moreover, patient characteristics did not influence the observed reduction in hypoglycaemia in T1D and T2D.
These results demonstrate that switching to degludec from other basal insulins was associated with reduced rates of hypoglycaemia, irrespective of the definition used or baseline patient characteristics.
NCT02392117.
低血糖是胰岛素治疗的常见副作用；糖化血红蛋白（HbA）水平过低或过高、低血糖病史或糖尿病病程较长都是已知的低血糖风险调节因素。在随机临床试验中，与其他基础胰岛素相比，新一代胰岛素类似物德谷胰岛素的低血糖发生率较低。
ReFLeCT研究是一项为期12个月的前瞻性观察性研究。从1型糖尿病（T1D）或2型糖尿病（T2D）患者中收集患者报告的低血糖日记数据，这些患者在常规临床护理中由医生酌情决定从其他基础胰岛素转换为德谷胰岛素。进行了两项二次分析以研究低血糖事件数量的变化：一项事后分析使用更新后的美国糖尿病协会（ADA）1级、2级和3级低血糖定义，以及一项预先指定的分析使用患者特征（基线HbA、糖尿病病程和医生启动德谷胰岛素的理由）。
对于T1D中的所有定义以及T2D中的1级和2级定义（3级事件太少，无法进行统计比较），转换为德谷胰岛素与低血糖事件显著减少相关。此外，患者特征并未影响T1D和T2D中观察到的低血糖减少情况。
这些结果表明，从其他基础胰岛素转换为德谷胰岛素与低血糖发生率降低相关，无论使用何种定义或患者基线特征如何。
NCT02392117。
