Kristensen P L, Tarnow L, Bay C, Nørgaard K, Jensen T, Parving H-H, Perrild H, Beck-Nielsen H, Christiansen J S, Thorsteinsson B, Pedersen-Bjergaard U
Nordsjaellands Hospital Hillerød, Department of Cardiology, Nephrology and Endocrinology, Hillerød, Denmark.
Steno Diabetes Centre, Department of Clinical Research, Gentofte, Denmark.
Diabet Med. 2017 May;34(5):625-631. doi: 10.1111/dme.13317. Epub 2017 Feb 14.
To assess the difference between analogue and human insulin with regard to nocturnal glucose profiles and risk of hypoglycaemia in people with recurrent severe hypoglycaemia.
A total of 72 people [46 men, mean ± sd age 54 ± 12 years, mean ± sd HbA 65 ± 12 mmol/mol (8.1 ± 1.1%), mean ± sd duration of diabetes 30 ± 14 years], who participated in a 2-year randomized, crossover trial of basal-bolus therapy with insulin detemir/insulin aspart or human NPH insulin/human regular insulin (the HypoAna trial) were studied for 2 nights during each treatment. Venous blood was drawn hourly during sleep. Primary endpoints were nocturnal glucose profiles and occurrence of hypoglycaemia (blood glucose ≤ 3.9 mmol/l).
During insulin analogue treatment, the mean nocturnal plasma glucose level was significantly higher than during treatment with human insulin (10.6 vs 8.1 mmol/l). The fasting plasma glucose level was similar between the treatments. Nocturnal hypoglycaemia was registered during 41/101 nights (41%) in the human insulin arm and 19/117 nights (16%) in the insulin analogue arm, corresponding to a hazard ratio of 0.26 (95% CI 0.14 to 0.45; P < 0.0001) with insulin analogue.
Treatment with insulin analogue reduces the occurrence of nocturnal hypoglycaemia assessed by nocturnal glucose profiles in people with Type 1 diabetes prone to severe hypoglycaemia. Nocturnal glucose profiles provide a more comprehensive assessment of clinical benefit of insulin regimens as compared to conventional recording of hypoglycaemia.
评估在夜间血糖情况以及反复发生严重低血糖的患者发生低血糖风险方面，类似物胰岛素与人胰岛素之间的差异。
共有72人[46名男性，平均±标准差年龄54±12岁，平均±标准差糖化血红蛋白65±12 mmol/mol（8.1±1.1%），平均±标准差糖尿病病程30±14年]参与了一项为期2年的关于地特胰岛素/门冬胰岛素或人NPH胰岛素/人常规胰岛素基础-餐时治疗的随机交叉试验（低血糖分析试验），在每种治疗期间对他们进行2个晚上的研究。睡眠期间每小时采集静脉血。主要终点是夜间血糖情况和低血糖的发生（血糖≤3.9 mmol/L）。
在胰岛素类似物治疗期间，夜间平均血浆葡萄糖水平显著高于人胰岛素治疗期间（10.6对8.1 mmol/L）。两种治疗之间空腹血浆葡萄糖水平相似。人胰岛素组在41/101个晚上（41%）记录到夜间低血糖，胰岛素类似物组在19/117个晚上（16%）记录到夜间低血糖，胰岛素类似物的风险比为0.26（95%可信区间0.14至0.45；P<0.0001）。
对于容易发生严重低血糖的1型糖尿病患者，通过夜间血糖情况评估，胰岛素类似物治疗可降低夜间低血糖的发生。与传统的低血糖记录相比，夜间血糖情况能更全面地评估胰岛素治疗方案的临床获益。
