Institut de recherches cliniques de Montréal, Montreal, QC, Canada; Division of Experimental Medicine, Department of Medicine, McGill University, Montreal, QC, Canada.
Montreal Children's Hospital, McGill University Health Centre, Montreal, QC, Canada.
Lancet Diabetes Endocrinol. 2015 Aug;3(8):595-604. doi: 10.1016/S2213-8587(15)00141-2. Epub 2015 Jun 8.
Additional benefits of the dual-hormone (insulin and glucagon) artificial pancreas compared with the single-hormone (insulin alone) artificial pancreas have not been assessed in young people in outpatient unrestricted conditions. We evaluated the efficacy of three systems for nocturnal glucose control in children and adolescents with type 1 diabetes.
We did a randomised, three-way, crossover trial in children aged 9-17 years with type 1 diabetes attending a diabetes camp in Canada. With use of sealed envelopes, children were randomly assigned in a 1:1:1:1:1:1 ratio with blocks of six to different sequences of the three interventions (single-hormone artificial pancreas, dual-hormone artificial pancreas, and conventional continuous subcutaneous insulin pump therapy). Each intervention was applied for 3 consecutive nights. Participants, study staff, and endpoint assessors were not masked. The primary outcome was the percentage of time spent with glucose concentrations lower than 4·0 mmol/L from 2300 h to 0700 h. Analysis was by intention to treat. A p value of less than 0·0167 was regarded as significant. This study is registered with ClinicalTrials.gov, number NCT02189694.
Between June 30, 2014, and Aug 9, 2014, we enrolled 33 children of mean age 13·3 years (SD 2·3; range 9-17). The time spent at a glucose concentration lower than 4·0 mmol/L was median 0% (IQR 0·0-2·4) during nights with the dual-hormone artificial pancreas, 3·1% (0·0-6·9) during nights with the single-hormone artificial pancreas (p=0·032), and 3·4% (0-11·0) during nights with conventional pump therapy (p=0·0048 compared with dual-hormone artificial pancreas and p=0·32 compared with single-hormone artificial pancreas). 15 hypoglycaemic events (<3·1 mmol/L for 20 min measured by sensor then confirmed with capillary glucose <4·0 mmol/L) were noted during nights with conventional pump therapy compared with four events with the single-hormone system and no events with the dual-hormone system. None of the assessed outcomes varied with the order in which children and young adults were assigned interventions.
The dual-hormone artificial pancreas could improve nocturnal glucose control in children and adolescents with type 1 diabetes. Longer and larger outpatient studies are now needed.
Canadian Diabetes Association, Fondation J A De Sève.
在门诊不受限制的条件下，尚未评估双重激素（胰岛素和胰高血糖素）人工胰腺与单一激素（仅胰岛素）人工胰腺相比的额外益处。我们评估了三种系统在夜间控制 1 型糖尿病儿童和青少年血糖的疗效。
我们在加拿大的一个糖尿病营地进行了一项随机、三向、交叉试验，纳入了年龄在 9-17 岁的 1 型糖尿病儿童。使用密封信封，按照 1:1:1:1:1:1 的比例，将儿童随机分配至三种干预措施的不同顺序（单激素人工胰腺、双激素人工胰腺和常规连续皮下胰岛素泵治疗）。每种干预措施连续应用 3 晚。参与者、研究人员和终点评估人员均未设盲。主要结局是从 2300 时至 0700 时血糖浓度低于 4.0mmol/L 的时间百分比。分析采用意向治疗。p 值小于 0.0167 被认为具有统计学意义。本研究在 ClinicalTrials.gov 注册，编号为 NCT02189694。
在 2014 年 6 月 30 日至 8 月 9 日期间，我们纳入了 33 名平均年龄为 13.3 岁（标准差 2.3；范围 9-17）的儿童。在使用双激素人工胰腺的夜间，血糖浓度低于 4.0mmol/L 的时间中位数为 0%（IQR 0.0-2.4），使用单激素人工胰腺的夜间为 3.1%（0.0-6.9）（p=0.032），使用常规泵治疗的夜间为 3.4%（0-11.0）（p=0.0048 与双激素人工胰腺相比，p=0.32 与单激素人工胰腺相比）。在使用常规泵治疗的夜间观察到 15 次低血糖事件（传感器测量 20 分钟后 <3.1mmol/L，然后用毛细血管血糖 <4.0mmol/L 确认），而使用单激素系统的夜间发生 4 次，使用双激素系统的夜间未发生低血糖事件。评估的结果均不受儿童和青少年接受干预的顺序影响。
双激素人工胰腺可改善 1 型糖尿病儿童和青少年的夜间血糖控制。现在需要进行更长时间和更大规模的门诊研究。
加拿大糖尿病协会， Fondation J A De Sève。
