Real-World Clinical Outcomes Following Initiation of the iLet® Bionic Pancreas in Youth with Type 1 Diabetes.

IF 7.4 2区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes technology & therapeutics Pub Date : 2026-10-14 DOI:10.1177/15209156261496625

Elizabeth R Sullivan-Ingram, Ortal Resnick, Mary Margaret Barr, Ambika P Ashraf

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引用次数: 0

Abstract

Background: The iLet^® Bionic Pancreas replaces carbohydrate counting and manual bolus calculations with simplified qualitative meal announcements. Its performance among diverse patients with high baseline glycated hemoglobin (HbA1c) is not well characterized.

Methods: Retrospective, single-center cohort study of 71 patients aged 6-21 years with type 1 diabetes (T1D) who initiated the iLet Bionic Pancreas (2023-2025). Primary outcomes were changes in HbA1c and time in range (TIR; 70-180 mg/dL [3.9-10.0 mmol/L]) from baseline to 3 months. Secondary outcomes included glycemic metrics through 12 months, hypoglycemia, and meal-announcement behavior.

Results: Mean age was 13.2 ± 3.5 years; 40.8% Black and 38.0% Medicaid-insured. Baseline HbA1c was 9.4 ± 2.1% (79 ± 23 mmol/mol) and TIR was 30.1 ± 19.0%. At 3 months, HbA1c decreased by 1.8 ± 1.7% (-20 ± 19 mmol/mol) and TIR increased by 22.4 ± 22.5 percentage points (both P < 0.0001) without increased hypoglycemia. Improvements were greatest among participants with baseline HbA1c ≥ 9.5% (≥80 mmol/mol) (ΔHbA1c = -3.0% [-32 mmol/mol]; ΔTIR = +31.2 percentage points). Among participants with paired 12-month data, HbA1c decreased from 9.6%-7.6% and TIR increased from 27.7 to 55.8% (both P < 0.0001). Mean meal announcements were 2.9/d at 3 months and 2.1/d at 12 months (P = 0.722) and were not associated with HbA1c or TIR at 3 months.

Conclusions: In this real-world pediatric cohort, iLet initiation was associated with substantial glycemic improvement without increased hypoglycemia, particularly among participants with high baseline HbA1c. Favorable outcomes were observed among participants contributing paired 12-month data.

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iLet®仿生胰腺治疗青少年1型糖尿病的临床效果

背景：iLet®仿生胰腺取代了碳水化合物计数和手动计算，简化了定性膳食公告。它在不同的高基线糖化血红蛋白（HbA1c）患者中的表现尚未得到很好的表征。方法：回顾性，单中心队列研究71例6-21岁的1型糖尿病（T1D）患者，他们启动了iLet仿生胰腺（2023-2025）。主要结局是HbA1c从基线到3个月的变化和时间范围（TIR; 70-180 mg/dL [3.9-10.0 mmol/L]）。次要结局包括12个月的血糖指标、低血糖和进餐通知行为。结果：平均年龄13.2±3.5岁；40.8%的黑人和38.0%的医疗保险。基线HbA1c为9.4±2.1%(79±23 mmol/mol)， TIR为30.1±19.0%。3个月时，HbA1c降低1.8±1.7%(-20±19 mmol/mol)， TIR升高22.4±22.5个百分点（P均< 0.0001），低血糖发生率未升高。基线HbA1c≥9.5%（≥80 mmol/mol）的参与者改善最大（ΔHbA1c = -3.0% [-32 mmol/mol]； ΔTIR = +31.2个百分点）。在配对12个月数据的参与者中，HbA1c从9.6%降至7.6%，TIR从27.7%上升至55.8% （P均< 0.0001）。3个月和12个月的平均膳食公告分别为2.9/d和2.1/d (P = 0.722)，与3个月时的HbA1c或TIR无关。结论：在这个现实世界的儿科队列中，iLet启动与血糖的显著改善相关，而没有增加低血糖，特别是在基线HbA1c较高的参与者中。在提供配对12个月数据的参与者中观察到良好的结果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes technology & therapeutics 医学-内分泌学与代谢

CiteScore

10.60

自引率

14.80%

发文量

145

审稿时长

3-8 weeks

期刊介绍： Diabetes Technology & Therapeutics is the only peer-reviewed journal providing healthcare professionals with information on new devices, drugs, drug delivery systems, and software for managing patients with diabetes. This leading international journal delivers practical information and comprehensive coverage of cutting-edge technologies and therapeutics in the field, and each issue highlights new pharmacological and device developments to optimize patient care.