Diabeteszentrum Bad Lauterberg, Kirchberg 21, 37431, Bad Lauterberg im Harz, Germany,
Diabetologia. 2014 May;57(5):868-77. doi: 10.1007/s00125-014-3168-1. Epub 2014 Jan 21.
AIMS/HYPOTHESIS: We evaluated whether self-monitoring of blood glucose (SMBG) leads to better glycaemic control (HbA(1c)) in patients with type 2 diabetes on conventional insulin regimens.
Patients with type 2 diabetes on a conventional insulin regimen (basal or premixed insulin with or without additional oral glucose-lowering agents) were recruited at study centres led by members of the German Diabetes Association. In a randomised, prospective, open 2 × 2 factorial design, the once-weekly performance of four-point glucose profiles (SMBG +; n = 151 patients) was compared with no SMBG (SMBG -; n = 149), and the measuring and transmitting of HbA1c results to the study centres (HbA(1c) +; n = 158, of these 82 SMBG - and 76 SMBG +) was compared with HbA1c measurement without disclosure of results (HbA(1c) -; n = 142, of these 67 SMBG - and 75 SMBG +). Randomised allocation was carried out by a central office, using sequentially numbered, sealed envelopes. The primary endpoint was the reduction of HbA(1c) compared with baseline after 12 months. Secondary analyses were of therapy intensification in response to higher blood or urinary glucose or HbA(1c). Participants and caregivers were not blinded as to the allocation of interventions, whereas the laboratory determining HbA(1c) remained blinded.
Patient characteristics were balanced across groups. A total of 56 patients dropped out. In completers, HbA(1c) was reduced in the SMBG + group from 7.3% to 7.0%, i.e. by 0.3% (0.1%, 0.5%) vs SMBG - from 7.3% to 7.0% and 0.3% (0.2%, 0.5%), respectively, the difference being 0.0% (-0.2%, 0.2%) (p = 0.93). The disclosure of HbA(1c) results had no significant influence, with a difference of 0.1% (-0.1%, 0.4%) (p = 0.28). Values above are mean (95% CI). The ORs for therapy intensification significantly rose as the following increased: proportions of urine samples testing positive for glucose, HbA1c concentrations, and fasting or postprandial glucose concentrations. No important adverse events were associated with the interventions.
CONCLUSIONS/INTERPRETATION: SMBG profiles once weekly or the disclosure of HbA(1c) results did not improve glycaemic control in patients with type 2 diabetes on conventional insulin treatment, although indicators of hyperglycaemia increased the likelihood of therapy intensification. Greater intensification may be necessary to impact on glycaemic control.
www.clinicaltrials.gov (registration code NCT00688363) FUNDING: Deutsche Diabetes-Gesellschaft, Deutsche Diabetes-Stiftung, Bayer Vital GmbH.
目的/假设：我们评估了自我血糖监测（SMBG）是否会改善接受常规胰岛素治疗的 2 型糖尿病患者的血糖控制（HbA1c）。
在由德国糖尿病协会成员领导的研究中心，招募了正在接受常规胰岛素治疗方案（基础或预混胰岛素，或联合使用其他口服降糖药物）的 2 型糖尿病患者。采用随机、前瞻性、开放的 2×2 析因设计，每周一次的四点血糖谱（SMBG+；n=151 例患者）与无 SMBG（SMBG-；n=149 例患者）进行比较，将 HbA1c 结果测量和传输至研究中心（HbA1c+；n=158 例患者，其中 82 例 SMBG-和 76 例 SMBG+）与 HbA1c 结果不公开测量（HbA1c-；n=142 例患者，其中 67 例 SMBG-和 75 例 SMBG+）进行比较。通过中央办公室使用顺序编号的密封信封进行随机分组。主要终点是治疗 12 个月后与基线相比 HbA1c 的降低。次要分析是针对更高的血糖或尿糖或 HbA1c 进行的治疗强化。参与者和护理人员无法对干预措施的分配进行盲法，而确定 HbA1c 的实验室则保持盲法。
患者特征在各组之间平衡。共有 56 名患者脱落。在完成治疗的患者中，SMBG+组的 HbA1c 从 7.3%降至 7.0%，即降低 0.3%（0.1%，0.5%），而 SMBG-组从 7.3%降至 7.0%和 0.3%（0.2%，0.5%），差异为 0.0%（-0.2%，0.2%）（p=0.93）。HbA1c 结果的披露没有显著影响，差异为 0.1%（-0.1%，0.4%）（p=0.28）。以上数值均为平均值（95%CI）。随着尿液样本中葡萄糖阳性的比例、HbA1c 浓度、空腹或餐后血糖浓度的增加，治疗强化的比值比显著上升。没有与干预措施相关的重要不良事件。
结论/解释：每周一次的 SMBG 谱或 HbA1c 结果的披露并没有改善接受常规胰岛素治疗的 2 型糖尿病患者的血糖控制，尽管高血糖的指标增加了治疗强化的可能性。可能需要更大程度的强化治疗才能对血糖控制产生影响。
www.clinicaltrials.gov（注册号 NCT00688363）
德国糖尿病协会、德国糖尿病基金会、拜耳生命有限公司。
Zotero 插件