Burnside Mercedes J, Lewis Dana M, Crocket Hamish R, Meier Renee A, Williman Jonathan A, Sanders Olivia J, Jefferies Craig A, Faherty Ann M, Paul Ryan G, Lever Claire S, Price Sarah K J, Frewen Carla M, Jones Shirley D, Gunn Tim C, Lampey Christina, Wheeler Benjamin J, de Bock Martin I
Department of Pediatrics, University of Otago, Christchurch, Christchurch, New Zealand.
Pediatric Department, Te Whatu Ora Health New Zealand Waitaha Canterbury, Christchurch, New Zealand.
Diabetes Technol Ther. 2023 Apr;25(4):250-259. doi: 10.1089/dia.2022.0484. Epub 2023 Feb 28.
To assess long-term efficacy and safety of open-source automated insulin delivery (AID) in children and adults (7-70 years) with type 1 diabetes. Both arms of a 24-week randomized controlled trial comparing open-source AID (OpenAPS algorithm within a modified version of AndroidAPS, preproduction DANA-i™ insulin pump, Dexcom G6 continuous glucose monitor) with sensor-augmented pump therapy (SAPT), entered a 24-week continuation phase where the SAPT arm (termed SAPT-AID) crossed over to join the open-source AID arm (termed AID-AID). Most participants (69/94) used a preproduction YpsoPump insulin pump during the continuation phase. Analyses incorporated all 52 weeks of data, and combined between-group and within-subject differences to calculate an overall "treatment effect" of AID versus SAPT. Mean time in range (TIR; 3.9-10 mmol/L [70-180 mg/dL]) was 12.2% higher with AID than SAPT (95% confidence interval [CI] 10.4 to 14.1; < 0.001). TIR was 56.9% (95% CI 54.2 to 59.6) with SAPT and 69.1% (95% CI 67.1 to 71.1) with AID. The treatment effect did not differ by age ( = 0.39) or insulin pump type ( = 0.37). HbA1c was 5.1 mmol/mol lower [0.5%] with AID (95% CI -6.6 to -3.6; < 0.001). There were no episodes of diabetic ketoacidosis or severe hypoglycemia with either treatment over the 48 weeks. Six participants (all in SAPT-AID) withdrew: three with hardware issues, two preferred SAPT, and one with infusion-site skin irritation. Further evaluation of the community derived automated insulin delivery (CREATE) trial to 48 weeks confirms that open-source AID is efficacious and safe with different insulin pumps, and demonstrates sustained glycemic improvements without additional safety concerns.
评估开源自动胰岛素给药（AID）在1型糖尿病儿童和成人（7至70岁）中的长期疗效和安全性。一项为期24周的随机对照试验，比较开源AID（安卓人工胰腺系统修改版中的开源人工胰腺系统算法、预生产的DANA-i™胰岛素泵、德康G6连续血糖监测仪）与传感器增强泵疗法（SAPT），两个试验组均进入了为期24周的延续阶段，其中SAPT组（称为SAPT-AID）交叉至开源AID组（称为AID-AID）。在延续阶段，大多数参与者（69/94）使用预生产的YpsoPump胰岛素泵。分析纳入了全部52周的数据，并结合组间差异和个体内差异来计算AID与SAPT的总体“治疗效果”。AID组的平均血糖达标时间（TIR；3.9至10 mmol/L [70至180 mg/dL]）比SAPT组高12.2%（95%置信区间[CI] 10.4至14.1；<0.001）。SAPT组的TIR为56.9%（95% CI 54.2至59.6），AID组为69.1%（95% CI 67.1至71.1）。治疗效果在年龄（P = 0.39）或胰岛素泵类型方面无差异（P = 0.37）。AID组的糖化血红蛋白（HbA1c）降低了5.1 mmol/mol [0.5%]（95% CI -6.6至-3.6；<0.001）。在48周的治疗期间，两种治疗方法均未出现糖尿病酮症酸中毒或严重低血糖事件。6名参与者（均在SAPT-AID组）退出：3名因硬件问题退出，2名更倾向于SAPT，1名因输注部位皮肤刺激退出。将社区衍生自动胰岛素给药（CREATE）试验进一步评估至48周证实，开源AID在使用不同胰岛素泵时有效且安全，并显示出血糖持续改善且无额外安全问题。
