Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Spain; Universidad de Málaga, Spain; CIBERDEM (CB07/08/0019), Instituto de Salud Carlos III, Madrid, Spain.
Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Spain; Universidad de Málaga, Spain.
Clin Nutr. 2020 Feb;39(2):388-394. doi: 10.1016/j.clnu.2019.02.036. Epub 2019 Mar 20.
There is no established insulin regimen in T2DM patients receiving parenteral nutrition.
To compare the effectiveness (metabolic control) and safety of two insulin regimens in patients with diabetes receiving TPN.
Prospective, open-label, multicenter, clinical trial on adult inpatients with type 2 diabetes on a non-critical setting with indication for TPN. Patients were randomized on one of these two regimens: 100% of RI on TPN or 50% of Regular insulin added to TPN bag and 50% subcutaneous GI. Data were analyzed according to intention-to-treat principle.
81 patients were on RI and 80 on GI. No differences were observed in neither average total daily dose of insulin, programmed or correction, nor in capillary mean blood glucose during TPN infusion (165.3 ± 35.4 in RI vs 172.5 ± 43.6 mg/dL in GI; p = 0.25). Mean capillary glucose was significantly lower in the GI group within two days after TPN interruption (160.3 ± 45.1 in RI vs 141.7 ± 43.8 mg/dL in GI; p = 0.024). The percentage of capillary glucose above 180 mg/dL was similar in both groups. The rate of capillary glucose ≤70 mg/dL, the number of hypoglycemic episodes per 100 days of TPN, and the percentage of patients with non-severe hypoglycemia were significantly higher on GI group. No severe hypoglycemia was detected. No differences were observed in length of stay, infectious complications, or hospital mortality.
Effectiveness of both regimens was similar. GI group achieved better metabolic control after TPN interruption but non-severe hypoglycemia rate was higher in the GI group.
This trial is registered at clinicaltrials.gov as NCT02706119.
接受肠外营养的 2 型糖尿病患者尚无既定的胰岛素方案。
比较两种胰岛素方案在接受 TPN 的糖尿病患者中的有效性（代谢控制）和安全性。
一项前瞻性、开放标签、多中心、临床试验，纳入非危重症、有 TPN 适应证的成年 2 型糖尿病住院患者。患者随机分为以下两种方案之一：TPN 中给予 100%胰岛素或 TPN 袋中加入 50%常规胰岛素和 50%皮下胰岛素。根据意向治疗原则分析数据。
81 例患者接受 RI 治疗，80 例患者接受 GI 治疗。在 TPN 输注期间，胰岛素的平均总日剂量、方案剂量或校正剂量，以及毛细血管平均血糖均无差异（RI 组为 165.3±35.4mg/dL，GI 组为 172.5±43.6mg/dL；p=0.25）。在 TPN 中断后两天内，GI 组毛细血管血糖明显更低（RI 组为 160.3±45.1mg/dL，GI 组为 141.7±43.8mg/dL；p=0.024）。两组毛细血管血糖超过 180mg/dL 的比例相似。低血糖发生率、每 100 天 TPN 发生低血糖的次数以及低血糖发生率均明显更高，非严重低血糖的发生率无差异。未发生严重低血糖。两组的住院时间、感染并发症或住院死亡率无差异。
两种方案的有效性相似。TPN 中断后 GI 组代谢控制更好，但 GI 组非严重低血糖发生率更高。
本试验在 clinicaltrials.gov 注册，编号为 NCT02706119。
