Participants with T1DM and IAH (Gold score ≥4) recruited to the HypoCOMPaSS (24-week 2 × 2 factorial randomised controlled) trial were included. All underwent screening for cardiac autonomic function testing at baseline and received comparable education and support aimed at avoiding hypoglycaemia and improving hypoglycaemia awareness. Definite CAN was defined as the presence of ≥2 abnormal cardiac reflex tests. Participants were grouped according to their CAN status, and changes in Gold score were compared.
Eighty-three participants (52 women [62.7%]) were included with mean age (SD) of 48 (12) years and mean HbA1c of 66 (13) mmol/mol (8.2 [3.3] %). The mean duration of T1DM was 29 (13) years. The prevalence of CAN was low with 5/83 (6%) participants having definite autonomic neuropathy with 11 (13%) classified with possible/early neuropathy. All participants, regardless of the autonomic function status, showed a mean improvement in Gold score of ≥1 (mean improvement -1.2 [95% CI -0.8, -1.6]; p < 0.001).
IAH can be improved in people with T1DM, and a long duration of disease, with and without cardiac autonomic dysfunction. These data suggest that CAN is not a prime driver for modulating IAH reversibility.
方法:纳入HypoCOMPaSS(24周2×2因子随机对照)试验的T1DM和IAH(Gold评分≥4)参与者。所有患者均在基线时接受了心脏自主神经功能测试的筛查,并接受了类似的教育和支持,旨在避免低血糖和提高对低血糖的认识。确定的CAN定义为存在≥2次异常心脏反射测试。参与者根据他们的CAN状态进行分组,并比较了Gold评分的变化。
结果:83名参与者(52名女性[62.7%])纳入研究,平均年龄(SD)为48(12)岁,平均HbA1c为66(13)mmol/mol(8.2[3.3%])。T1DM的平均病程为29(13)年。CAN的患病率较低,有5/83(6%)的参与者具有明确的自主神经病变,其中11(13%)被分类为可能/早期神经病。所有参与者,无论自主功能状态如何,Gold评分平均改善≥1(平均改善-1.2[95%CI-0.8,-1.6];p<0.001)。
结论:IAH可在T1DM患者中得到改善,和长期的疾病,有和没有心脏自主神经功能障碍。这些数据表明CAN不是调节IAH可逆性的主要驱动因素。