Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial
Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial
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DOI：
10.1016/s0140-6736(14)61037-0
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发表时间：
2014-10-04
期刊：
影响因子：
168.9
通讯作者：
Lee, Scott W.
中科院分区：
文献类型：
--
作者：
Reznik, Yves;Cohen, Ohad;Lee, Scott W.
许多晚期2型糖尿病患者不能达到糖化血红蛋白目标，比较胰岛素泵治疗和每日多次注射胰岛素治疗患者降糖疗效的随机对照研究得出了不确定的结果。我们的目的是解决这种不确定性与随机对照试验（OpT2TRYS.Methods），我们在36家医院，三级保健中心，并在加拿大，欧洲，以色列，南非和美国的医疗中心，这是一个多中心，对照试验。尽管每天多次注射胰岛素类似物但血糖控制不佳的2型糖尿病患者入组2个月剂量优化导入期。导入期后，糖化血红蛋白为8. 0 - 12. 0%（64-108 mmol/mol）的患者通过计算机生成的随机化序列（2号区组的概率为0. 75，4号区组的概率为0. 25）随机分配（1：1）接受泵治疗或继续每日多次注射。患者和研究者均未对治疗分配设盲。主要终点是意向治疗人群基线至随机化阶段结束时平均糖化血红蛋白的变化。该研究注册于ClinicalTrials.gov，编号NCT 01182493。结果590例筛选患者中有495例进入导入期，331例随机分配（168例接受泵治疗，163例接受每日多次注射）。两组基线时平均糖化血红蛋白为9%（75 mmol/mol）。在6个月时，平均糖化血红蛋白降低了1.1%，（SD 1.2; 12 mmol/mol，SD 13）和0.4%（SD 1.1; 4 mmol/mol，SD 12），导致组间治疗差异为-0.7%（95% CI -0.9至-0.4; -8 mmol/mol，95% CI -10至-4，p < 0.0001）。研究结束时，胰岛素泵治疗组的平均每日胰岛素总剂量为97个单位（SD 56），每日多次注射组为122个单位（SD 68）（p < 0.0001），两组之间的体重变化无显著差异（1.5 kg [SD 3.5] vs 1.1 kg [3.6]，p = 0.322）。胰岛素泵治疗组发生了2例导致住院的糖尿病相关严重不良事件（高血糖症或酮症，无酸中毒），而每日多次注射组发生了1例。两组均未发生酮症酸中毒，每日多次注射组中发生了一次严重低血糖发作。解释尽管使用每日多次注射胰岛素，但2型糖尿病控制不佳的患者，泵治疗可被视为一种安全且有价值的治疗选择。
Background Many patients with advanced type 2 diabetes do not meet their glycated haemoglobin targets and randomised controlled studies comparing the efficacy of pump treatment and multiple daily injections for lowering glucose in insulin-treated patients have yielded inconclusive results. We aimed to resolve this uncertainty with a randomised controlled trial (OpT2mise).Methods We did this multicentre, controlled trial at 36 hospitals, tertiary care centres, and referal centres in Canada, Europe, Israel, South Africa, and the USA. Patients with type 2 diabetes who had poor glycaemic control despite multiple daily injections with insulin analogues were enrolled into a 2-month dose-optimisation run-in period. After the run-in period, patients with glycated haemoglobin of 8 .0-12.0% (64-108 mmol/mol) were randomly assigned (1: 1) by a computer-generated randomisation sequence (block size 2 with probability 0.75 and size 4 with probability 0.25) to pump treatment or to continue with multiple daily injections. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was change in mean glycated haemoglobin between baseline and end of the randomised phase for the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01182493.Findings 495 of 590 screened patients entered the run-in phase and 331 were randomised (168 to pump treatment, 163 to multiple daily injections). Mean glycated haemoglobin at baseline was 9% (75 mmol/mol) in both groups. At 6 months, mean glycated haemoglobin had decreased by 1 .1% (SD 1.2; 12 mmol/mol, SD 13) in the pump treatment group and 0.4% (SD 1.1; 4 mmol/mol, SD 12) in the multiple daily injection group, resulting in a between-group treatment difference of -0.7% (95% CI -0.9 to -0.4; -8 mmol/mol, 95% CI -10 to -4, p < 0.0001). At the end of the study, the mean total daily insulin dose was 97 units (SD 56) with pump treatment versus 122 units (SD 68) for multiple daily injections (p < 0.0001), with no significant difference in bodyweight change between the two groups (1.5 kg [SD 3.5] vs 1.1 kg [3.6], p = 0.322). Two diabetes-related serious adverse events (hyperglycaemia or ketosis without acidosis) resulting in hospital admission occurred in the pump treatment group compared with one in the multiple daily injection group. No ketoacidosis occurred in either group and one episode of severe hypoglycaemia occurred in the multiple daily injection group.Interpretation In patients with poorly controlled type 2 diabetes despite using multiple daily injections of insulin, pump treatment can be considered as a safe and valuable treatment option.