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首页> 外文期刊>Diabetes care >Recovery of hypoglycemia awareness in long-standing type 1 diabetes: A multicenter 2 × 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS)
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Recovery of hypoglycemia awareness in long-standing type 1 diabetes: A multicenter 2 × 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS)

机译：长期存在的1型糖尿病患者对低血糖意识的恢复：一项多中心2×2析因随机对照试验，比较了每天多次注射胰岛素泵和常规血糖自我监测（HypoCOMPaSS）连续进行的胰岛素泵

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OBJECTIVE: To determine whether impaired awareness of hypoglycemia (IAH) can be improved and severe hypoglycemia (SH) prevented in type 1 diabetes, we compared an insulin pump (continuous subcutaneous insulin infusion [CSII]) with multiple daily injections (MDIs) and adjuvant real-time continuous glucose monitoring (RT) with conventional self-monitoring of blood glucose (SMBG). RESEARCH DESIGN AND METHODS: A 24-week 2 × 2 factorial randomized controlled trial in adults with type 1 diabetes and IAH was conducted. All received comparable education, support, and congruent therapeutic targets aimed at rigorous avoidance of biochemical hypogly-cemia without relaxing overall control. Primary end point was between-intervention difference in 24-week hypoglycemia awareness (Gold score). RESULTS: A total of 96 participants (mean diabetes duration 29 years) were randomized. Overall, biochemical hypoglycemia (≤3.0 mmol/L) decreased (53 ± 63 to 24 ± 56 min/24 h; P = 0.004 [t test]) without deterioration in HbA1c. Hypoglycemia awareness improved (5.1 ± 1.1 to 4.1 ± 1.6; P = 0.0001 [t test]) with decreased SH (8.9 ± 13.4 to 0.8 ± 1.8 episodes/patient-year; P = 0.0001 [t test]). At 24 weeks, there was no significant difference in awareness comparing CSII with MDI (4.1 ± 1.6 vs. 4.2 ± 1.7; difference 0.1; 95% CI 20.6to 0.8) and RTwith SMBG (4.3 ± 1.6 vs. 4.0 ± 1.7; difference 20.3; 95% CI 21.0 to 0.4). Between-group analyses demonstrated comparable reductions in SH, fear of hypoglycemia, and insulin doses with equivalent HbA1c. Treatment satisfaction was higher with CSII than MDI (32 ± 3 vs. 29 ± 6; P = 0.0003 [t test]), but comparable with SMBG and RT (30 ± 5 vs. 30 ± 5; P = 0.79 [t test]). CONCLUSIONS: Hypoglycemia awareness can be improved and recurrent SH prevented in longstanding type 1 diabetes without relaxing HbA1c. Similar biomedical outcomes can be attained with conventional MDI and SMBG regimens compared with CSII/RT, although satisfaction was higher with CSII.
机译：目的：为确定是否可以改善1型糖尿病患者对低血糖（IAH）的意识障碍和严重的低血糖（SH），我们将胰岛素泵（连续皮下注射胰岛素[CSII]）与每日多次注射（MDI）和佐剂进行了比较实时连续血糖监测（RT）和常规的自我血糖监测（SMBG）。研究设计与方法：进行了一项针对1型糖尿病和IAH成年人的24周2×2析因随机对照试验。所有人均获得了可比的教育，支持和一致的治疗目标，目的是在不放松总体控制的情况下，严格避免生化低血糖症。主要终点为24周低血糖意识的干预之间差异（金评分）。结果：总共96名参与者（平均糖尿病持续时间29年）被随机分组​​。总体而言，生化性低血糖症（≤3.0mmol / L）减少了（53±63至24±56 min / 24 h; P = 0.004 [t测试]），而HbA1c并未恶化。低血糖意识得到改善（5.1±1.1至4.1±1.6; P = 0.0001 [t检验]），SH下降（8.9±13.4至0.8±1.8发作/患者年; P = 0.0001 [t检验]）。在第24周时，与CSII与MDI相比（4.1±1.6 vs. 4.2±1.7;差异0.1; 95％CI 20.6至0.8）和RT与SMBG的认知（4.3±1.6 vs. 4.0±1.7;差异20.3）没有显着差异。 ; 95％CI 21.0到0.4）。组间分析表明，与等效的HbA1c相比，SH的降低，可疑的低血糖症和胰岛素剂量的降低均相当。 CSII的治疗满意度高于MDI（32±3 vs. 29±6; P = 0.0003 [t检验]），但与SMBG和RT相当（30±5 vs. 30±5; P = 0.79 [t检验]）。 ）。结论：在不放松HbA1c的情况下，可以改善长期1型糖尿病患者的低血糖意识，并防止其复发。与CSII / RT相比，常规MDI和SMBG方案可以达到相似的生物医学结果，尽管CSII的满意度更高。

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