Jaeb Center for Health Research, Tampa, FL, USA.
Jaeb Center for Health Research, Tampa, FL, USA.
Lancet Diabetes Endocrinol. 2017 Sep;5(9):700-708. doi: 10.1016/S2213-8587(17)30217-6. Epub 2017 Jul 12.
The benefit of initiation of insulin pump therapy (continuous subcutaneous insulin infusion; CSII) in patients with type 1 diabetes using continuous glucose monitoring (CGM) has not been studied. We aimed to assess glycaemic outcomes when switching from multiple daily injections (MDI) to CSII in adults with type 1 diabetes using CGM.
In this multicentre, randomised controlled trial, 75 adults with type 1 diabetes in the CGM group of the DIAMOND trial were randomly assigned via the study website using a computer-generated sequence to continue MDI or switch to CSII, with continuation of CGM, for 28 weeks. The primary outcome was CGM-measured time in the glucose concentration range of 70-180 mg/dL (3·9-10·0 mmol/L). This study is registered with ClinicalTrials.gov, number NCT02282397.
Between April 14, 2015, and May 5, 2016, 37 participants were randomly assigned to the CGM plus CSII group and 38 participants were randomly assigned to the CGM plus MDI group. The study was completed by 36 (97%) of 37 participants in the CGM plus CSII group and 35 (92%) of 38 participants in the CGM plus MDI group. Mean CGM use was 6·7 days per week (SD 0·8) in the CGM plus CSII group and 6·9 days per week (0·3) in the CGM plus MDI group (p=0·86). No participants in the CGM plus CSII group who completed the trial discontinued CSII. Over the follow-up period, mean time in the glucose concentration range of 70-180 mg/dL (3·9-10·0 mmol/L) was 791 min per day (SD 157) in the CGM plus CSII group and 741 min per day (225) in the CGM plus MDI group (adjusted mean treatment group difference: 83 min, 95% CI 17-149; p=0·01). Participants in the CGM plus CSII group had a greater reduction in CGM-measured mean glucose (p=0·005) and hyperglycaemia (on four metrics: p=0·007 for >180 mg/dL [>10·0 mmol/L], p=0·02 for >250 mg/dL [>13·9 mmol/L], p=0·04 for >300 mg/dL [>16·6 mmol/L], and p=0·02 for the area under the curve for 180 mg/dL [10·0 mmol/L]), but also an increase in CGM-measured hypoglycaemia (p=0·0001 for <70 mg/dL [<3·9 mmol/L], p=0·0002 for <60 mg/dL [<3·3 mmol/L], p=0·0009 for <50 mg/dL [<2·8 mmol/L], p=0·0002 for the area over the curve for 70 mg/dL [3·9 mmol/L]). Mean HbA change from baseline to 28 weeks was 0·3% (SD 0·9; 3·3 mmol/mol [SD 9·8]) in the CGM plus CSII group and 0·1% (0·4; 1·1 mmol/mol [4·4]) in the CGM plus MDI group (p=0·32). Severe hypoglycaemia occurred in one participant in the CGM plus MDI group, and diabetic ketoacidosis and severe hyperglycaemia occurred in one participant each in the CGM plus CSII group.
Our findings show that glycaemic control measured by time in the glucose range of 70-180 mg/dL (3·9-10·0 mmol/L) is improved by initiation of CSII in adults with type 1 diabetes. However, biochemical hypoglycaemia also was increased in the study, which will be important to consider when incorporating these results into clinical practice.
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在使用连续血糖监测（CGM）的 1 型糖尿病患者中，起始胰岛素泵治疗（持续皮下胰岛素输注；CSII）的益处尚未得到研究。我们旨在评估在使用 CGM 的 1 型糖尿病患者中从多次每日注射（MDI）切换到 CSII 时的血糖控制结果。
在这项多中心、随机对照试验中，CGM 组的 DIAMOND 试验中的 75 名 1 型糖尿病成人患者通过研究网站使用计算机生成的序列进行随机分组，继续使用 MDI 或切换到 CSII，同时继续使用 CGM，为期 28 周。主要结局是 CGM 测量的血糖浓度在 70-180mg/dL（3.9-10.0mmol/L）范围内的时间。本研究在 ClinicalTrials.gov 注册，编号为 NCT02282397。
2015 年 4 月 14 日至 2016 年 5 月 5 日期间，37 名参与者被随机分配到 CGM 加 CSII 组，38 名参与者被随机分配到 CGM 加 MDI 组。37 名参与者中有 36 名（97%）完成了 CGM 加 CSII 组的研究，38 名参与者中有 35 名（92%）完成了 CGM 加 MDI 组的研究。CGM 加 CSII 组平均每周使用 CGM 6.7 天（标准差 0.8），CGM 加 MDI 组平均每周使用 CGM 6.9 天（0.3）（p=0.86）。在完成试验的 CGM 加 CSII 组中，没有参与者停止使用 CSII。在随访期间，CGM 加 CSII 组的血糖浓度在 70-180mg/dL（3.9-10.0mmol/L）范围内的平均时间为每天 791 分钟（标准差 157），CGM 加 MDI 组为每天 741 分钟（225）（调整后的治疗组差异：83 分钟，95%置信区间 17-149；p=0.01）。CGM 加 CSII 组的 CGM 测量平均血糖（p=0.005）和高血糖（四项指标：血糖浓度>180mg/dL[>10.0mmol/L]时 p=0.007，血糖浓度>250mg/dL[>13.9mmol/L]时 p=0.02，血糖浓度>300mg/dL[>16.6mmol/L]时 p=0.04，血糖浓度>180mg/dL[10.0mmol/L]时曲线下面积 p=0.02）降低幅度更大，但 CGM 测量的低血糖（血糖浓度<70mg/dL [<3.9mmol/L]时 p=0.0001，血糖浓度<60mg/dL [<3.3mmol/L]时 p=0.0002，血糖浓度<50mg/dL [<2.8mmol/L]时 p=0.0009，血糖浓度<70mg/dL [<3.9mmol/L]时曲线下面积 p=0.02）也增加。从基线到 28 周时，CGM 加 CSII 组的 HbA1c 变化为 0.3%（标准差 0.9；3.3mmol/mol[标准差 9.8]），CGM 加 MDI 组为 0.1%（0.4；1.1mmol/mol[4.4]）（p=0.32）。CGM 加 MDI 组有 1 名参与者发生严重低血糖，CGM 加 CSII 组各有 1 名参与者发生糖尿病酮症酸中毒和严重高血糖。
我们的研究结果表明，通过 CGM 测量的血糖浓度在 70-180mg/dL（3.9-10.0mmol/L）范围内，在使用 CGM 的 1 型糖尿病患者中起始 CSII 治疗可改善血糖控制。然而，研究中也出现了生化性低血糖，这在将这些结果纳入临床实践时将是重要的考虑因素。
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