Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands.
Cancer Center Amsterdam, Amsterdam, the Netherlands.
JAMA Surg. 2022 Oct 1;157(10):950-957. doi: 10.1001/jamasurg.2022.3702.
Glucose control in patients after total pancreatectomy is problematic because of the complete absence of α- and β-cells, leading to impaired quality of life. A novel, bihormonal artificial pancreas (BIHAP), using both insulin and glucagon, may improve glucose control, but studies in this setting are lacking.
To assess the efficacy and safety of the BIHAP in patients after total pancreatectomy.
DESIGN, SETTING, AND PARTICIPANTS: This randomized crossover clinical trial compared the fully closed-loop BIHAP with current diabetes care (ie, insulin pump or pen therapy) in 12 adult outpatients after total pancreatectomy. Patients were recruited between August 21 and November 16, 2020. This first-in-patient study began with a feasibility phase in 2 patients. Subsequently, 12 patients were randomly assigned to 7-day treatment with the BIHAP (preceded by a 5-day training period) followed by 7-day treatment with current diabetes care, or the same treatments in reverse order. Statistical analysis was by Wilcoxon signed rank and Mann-Whitney U tests, with significance set at a 2-sided P < .05.
The primary outcome was the percentage of time spent in euglycemia (70-180 mg/dL [3.9-10 mmol/L]) as assessed by continuous glucose monitoring.
In total, 12 patients (7 men and 3 women; median [IQR] age, 62.5 [43.1-74.0] years) were randomly assigned, of whom 3 did not complete the BIHAP phase and 1 was replaced. The time spent in euglycemia was significantly higher during treatment with the BIHAP (median, 78.30%; IQR, 71.05%-82.61%) than current diabetes care (median, 57.38%; IQR, 52.38%-81.35%; P = .03). In addition, the time spent in hypoglycemia (<70 mg/dL [3.9 mmol/L]) was lower with the BIHAP (median, 0.00% [IQR, 0.00%-0.07%] vs 1.61% [IQR, 0.80%-3.81%]; P = .004). No serious adverse events occurred.
Patients using the BIHAP after total pancreatectomy experienced an increased percentage of time in euglycemia and a reduced percentage of time in hypoglycemia compared with current diabetes care, without apparent safety risks. Larger randomized trials, including longer periods of treatment and an assessment of quality of life, should confirm these findings.
trialregister.nl Identifier: NL8871.
由于全胰切除术后患者完全缺乏α-和β-细胞，导致生活质量受损，因此对其进行血糖控制存在问题。一种新型的双激素人工胰腺（BIHAP），同时使用胰岛素和胰高血糖素，可能改善血糖控制，但在这种情况下缺乏研究。
评估 BIHAP 在全胰切除术后患者中的疗效和安全性。
设计、地点和参与者：这项随机交叉临床试验比较了完全闭环的 BIHAP 与全胰切除术后 12 名成年门诊患者的当前糖尿病护理（即胰岛素泵或笔治疗）。患者于 2020 年 8 月 21 日至 11 月 16 日之间招募。这项首次在患者中进行的研究首先在 2 名患者中进行了可行性阶段。随后，将 12 名患者随机分配到接受 BIHAP 治疗 7 天（先进行 5 天的培训期），然后接受当前糖尿病护理治疗 7 天，或按相同顺序进行相反的治疗。统计分析采用 Wilcoxon 符号秩和检验和 Mann-Whitney U 检验，双侧 P 值<.05 为差异有统计学意义。
主要结局是通过连续血糖监测评估的血糖正常（70-180mg/dL [3.9-10mmol/L]）时间百分比。
总共 12 名患者（7 名男性和 3 名女性；中位[IQR]年龄，62.5[43.1-74.0]岁）被随机分配，其中 3 名患者未完成 BIHAP 阶段，1 名患者被替换。使用 BIHAP 治疗时，血糖正常时间明显高于当前糖尿病护理（中位数 78.30%；IQR 71.05%-82.61%）（中位数 57.38%；IQR 52.38%-81.35%；P=.03）。此外，使用 BIHAP 时，低血糖（<70mg/dL [3.9mmol/L]）时间较低（中位数 0.00%[IQR 0.00%-0.07%]与 1.61%[IQR 0.80%-3.81%]；P=.004）。未发生严重不良事件。
与当前糖尿病护理相比，全胰切除术后使用 BIHAP 的患者血糖正常时间百分比增加，低血糖时间百分比降低，且无明显安全风险。更大规模的随机试验，包括更长时间的治疗和生活质量评估，应该证实这些发现。
trialregister.nl 标识符：NL8871。
