OBJECTIVE The HypoCOMPaSS study was designed to test the hypothesis that successful avoidance of biochemical hypoglycemia without compromising overall glycemic control would restore sufficient hypoglycemia awareness to prevent recurrent severe hypoglycemia in the majority of participants with established type 1 diabetes. Before starting the study, we planned to investigate associations between baseline characteristics and recurrent severe hypoglycemia over 2 years' follow-up. RESEARCH DESIGN AND METHODS A total of 96 adults with type 1 diabetes and impaired awareness of hypoglycemia participated in a 24-week 2 × 2 factorial randomized controlled trial comparing insulin delivery and glucose monitoring modalities, with the goal of rigorous biochemical hypoglycemia avoidance. The analysis included 71 participants who had experienced severe hypoglycemia in the 12-month prestudy with confirmed absence (complete responder) or presence (incomplete responder) of severe hypoglycemia over 24 months' follow-up. RESULTS There were 43 (61%) complete responders and 28 (39%) incomplete responders experiencing mean ± SD 1.5 ± 1.0 severe hypoglycemia events/person-year. At 24 months, incomplete responders spent no more time with glucose ≤3 mmol/L (1.4 ± 2.1% vs. 3.0 ± 4.8% for complete responders; P = 0.26), with lower total daily insulin dose (0.45 vs. 0.58 units/24 h; P = 0.01) and greater impairment of hypoglycemia awareness (Clarke score: 3.8 ± 2.2 vs. 2.0 ± 1.9; P = 0.01). Baseline severe hypoglycemia rate (16.9 ± 16.3 vs. 6.4 ± 10.8 events/person-year; P = 0.002) and fear of hypoglycemia were higher in incomplete responders. Peripheral neuropathy was more prevalent in incomplete responders (11 [39%] vs. 2 [4.7%]; P < 0.001) with a trend toward increased autonomic neuropathy. CONCLUSIONS Recurrent severe hypoglycemia was associated with higher preintervention severe hypoglycemia rate, fear of hypoglycemia, and concomitant neuropathy.

中文翻译：

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在HypoCOMPaSS研究过程中，患有1型糖尿病和低血糖意识受损的成年人反复发作的严重低血糖的预测指标。

目的HypoCOMPaSS研究旨在检验以下假设：成功地避免生化性低血糖而不损害总体血糖控制将恢复足够的低血糖意识，以预防大多数已建立的1型糖尿病患者复发严重的低血糖。在开始研究之前，我们计划在2年的随访中调查基线特征与复发性严重低血糖之间的关联。研究设计与方法共有96名1型糖尿病和低血糖意识受损的成人参加了一项为期24周的2×2析因随机对照试验，比较了胰岛素输送和血糖监测方式，目的是严格避免生化低血糖。该分析包括71名在12个月的研究中经历了严重低血糖症的参与者，并在24个月的随访中证实了严重低血糖症的存在（完全缓解）或存在（不完全缓解）。结果有43名（61％）完全缓解者和28名（39％）不完全缓解者经历了平均±SD 1.5±1.0严重低血糖事件/人年。在24个月时，不完全反应者不再花费更多时间在葡萄糖≤3mmol / L时（1.4±2.1％对完全反应者为3.0±4.8％； P = 0.26），每日总胰岛素剂量较低（0.45对0.58单位/ 24小时； P = 0.01）和对低血糖意识的更大损害（克拉克评分：3.8±2.2 vs. 2.0±1.9； P = 0.01）。基线严重低血糖发生率（16.9±16.3 vs.6.4±10.8事件/人年; P = 0。002）在不完全应答者中对低血糖的恐惧更高。周围神经病变在不完全反应者中更为普遍（11 [39％]比2 [4.7％]； P <0.001），并有自主神经病变增加的趋势。结论反复发作的严重低血糖症与干预前的严重低血糖症发生率较高，对低血糖症的恐惧以及伴随的神经病有关。