Combined improvements in implantable pump technology and insulin stability allow safe and effective long term intraperitoneal insulin delivery in type 1 diabetic patients: the EVADIAC experience
Combined improvements in implantable pump technology and insulin stability allow safe and effective long term intraperitoneal insulin delivery in type 1 diabetic patients: the EVADIAC experience
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DOI：
10.1016/s1262-3636(07)70075-7
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发表时间：
2003-12-01
影响因子：
7.2
通讯作者：
Catargi, B
中科院分区：
文献类型：
--
作者：
Gin, H;Renard, E;Catargi, B
目的：报告1型糖尿病患者植入式胰岛素泵的长期多中心经验，并在输注胰岛素溶液和腹膜导管改进后测试系统的安全性和准确性。研究设计与方法：将40台2001型MiniMed植入式泵连续植入1型糖尿病志愿者2个月。该系统配备了一个新的合规侧孔导管，每隔45天重新填充一次HOE 21 PH ETP胰岛素批次，显示出增强的体外物理稳定性。安全性通过急性不良事件的发生率和季度HbA（1c）检测的有效性来评估。通过将泵库中的剩余胰岛素与根据程序输液的预期量进行比较，在每次泵重新填充时测量输送的准确性。研究一直持续到泵电池耗尽或泵过早外植。结果：累计经验为106例患者年。3例发生过早解释，1例电子泵故障，2例“泵袋”感染。在13例中，接近正常的胰岛素输送持续到预期的电池耗尽。在24个泵中发生了40个输送不足事件，但其中36个与泵中胰岛素聚集导致的泵速减慢有关，这些问题通过门诊NaOH冲洗程序迅速解决。只有4例分娩不足是由导管阻塞引起的，需要腹腔镜切除导管周围过度生长的腹膜组织。在泵的使用寿命中，13例无输送不足患者的HbA（1c）为7.2 +/- 0.2%，其他患者的HbA（1c）为7.7 +/- 0.5%。在整个研究过程中，仅发生1例严重低血糖和1例酮症酸中毒。结论：我们目前改进的植入式泵和胰岛素溶液的经验表明，在改善输注胰岛素溶液和导管后，这种治疗方法对1型糖尿病患者具有长期的安全性和有效性。这种疗法可能是一个很好的替代患者经历频繁严重低血糖强化皮下胰岛素治疗。
Objective: To report a long-term multicentre experience with implantable insulin pumps in type 1 diabetic patients, and to test safety and accuracy of the systems following improvements in infused insulin solutions and peritoneal catheter.Research design and methods: Forty MiniMed Implantable Pumps model 2001 were consecutively implanted over a two-month period in type 1 diabetic volunteers. The systems were equipped by a new compliant sideport catheter and were refilled at 45-day intervals with HOE 21 PH ETP insulin batches showing enhanced physical stability in vitro. Safety was assessed from the incidence of acute adverse events and effectiveness from quarterly HbA(1c) assays. Accuracy of delivery was measured at each pump refill by comparing residual insulin in the pump reservoir with expected amount according to programmed infusion. The study lasted until pump battery depletion or premature pump explantation.Results: Cumulated experience was 106 patient-years. Premature explantations occurred in 3 cases, due to one electronic pump failure and two "pump-pocket" infections. Near-normal insulin delivery was sustained until expected battery depletion in 13 cases. Forty underdelivery events occurred in 24 pumps, but 36 among them were related to pump slowdowns due to insulin aggregation in pumps that were promply solved by an outpatient NaOH rinse procedure. Only 4 under-deliveries were caused by catheter obstructions that required laparoscopy to remove peritoneal tissue overgrowth around the catheter. Over pump lifetime, HbA(1c) was 7.2 +/- 0.2% in the 13 patients with no underdelivery and 7.7 +/- 0.5% in the other ones. Only one severe hypoglycemia and one ketoacidosis occurred during the whole study.Conclusion: Our current experience with improved implantable pumps and insulin solutions shows both long-term safety and effectiveness of this treatment in type 1 diabetic patients following improvement in infused insulin solutions and catheter. This therapy may be a good alternative for patients that experience frequent severe hypoglycemia with intensive subcutaneous insulin therapy.