Department of Internal Medicine III, Universitätsklinikum Jena, Jena, Germany.
Diabetes Care. 2013 Jul;36(7):1865-9. doi: 10.2337/dc12-1694. Epub 2013 Jan 22.
Patients with diabetes and insulin therapy with human insulin were usually instructed to use an interval of 20-30 min between the injection and meal. We examined the necessity of the injection-to-meal interval (IMI) in patients with type 2 diabetes mellitus (T2DM) and flexible insulin therapy with human insulin.
In this randomized, open crossover trial, 100 patients with T2DM (47% men, mean age = 66.7 years) were randomized to the IMI first group (phase 1, IMI 20 min; phase 2, no IMI) or IMI last group (phase 1, no IMI; phase 2, IMI 20 min). The main outcome measures were HbA1c, blood glucose profile, incidence of hypoglycemia, quality of life, treatment satisfaction, and patient preference.
Forty-nine patients were randomized to the IMI first group and 51 patients to the IMI last group. Omitting the IMI only slightly increases HbA1c (average intraindividual difference = 0.08% [95% CI 0.01-0.15]). Since the difference is not clinically relevant, a therapy without IMI is noninferior to its application (P < 0.001). In the secondary outcomes, the incidence of mild hypoglycemia also did not differ between no IMI and IMI significantly (mean of differences = -0.10, P = 0.493). No difference in the blood glucose profile of both groups was found. Treatment satisfaction increased markedly, by 8.08, if IMI was omitted (P < 0.001). The total score of the quality of life measure did not show differences between applying an IMI or not. Insulin therapy without IMI was preferred by 86.5% of patients (P < 0.001).
An IMI for patients with T2DM and preprandial insulin therapy is not necessary.
接受人胰岛素胰岛素治疗的糖尿病患者通常被指示在注射和用餐之间留出 20-30 分钟的间隔。我们检查了 2 型糖尿病（T2DM）患者和人胰岛素灵活胰岛素治疗中注射到用餐间隔（IMI）的必要性。
在这项随机、开放交叉试验中，100 名 T2DM 患者（47%为男性，平均年龄=66.7 岁）被随机分配到 IMI 第一组（第 1 阶段，IMI 20 分钟；第 2 阶段，无 IMI）或 IMI 最后一组（第 1 阶段，无 IMI；第 2 阶段，IMI 20 分钟）。主要观察指标为 HbA1c、血糖谱、低血糖发生率、生活质量、治疗满意度和患者偏好。
49 名患者被随机分配到 IMI 第一组，51 名患者被随机分配到 IMI 最后一组。省略 IMI 仅使 HbA1c 略有升高（个体内平均差异=0.08%[95%CI0.01-0.15%]）。由于差异无临床意义，因此无 IMI 的治疗与应用无差异（P<0.001）。在次要结局中，无 IMI 和 IMI 之间轻度低血糖的发生率也无显著差异（差异均值=-0.10，P=0.493）。两组的血糖谱均无差异。如果省略 IMI，治疗满意度显著增加 8.08（P<0.001）。生活质量测量的总分在应用或不应用 IMI 之间没有差异。86.5%的患者更喜欢无 IMI 的胰岛素治疗（P<0.001）。
2 型糖尿病和餐前胰岛素治疗的患者不需要 IMI。
