Medicina Generale Diabetologia, Dipartimento di Continuità di Cura e Fragilità, ASST Spedali Civili, Brescia, Italy.
Eur J Med Res. 2024 Jul 15;29(1):365. doi: 10.1186/s40001-024-01946-w.
Advanced Hybrid Closed-Loop system (AHCL) has profoundly changed type 1 diabetes therapy. This study primarily aimed to assess the impact on Glycemia Risk Index (GRI) and other continuous glucose monitoring (CGM) metrics when switching from one of four insulin strategies to AHCL in type 1 adult patients.
A single-center, retrospective pre/post observational study; 198 patients (age 44.4 ± 12.7 years, 115 females/83 males, diabetes duration 24.7 ± 11.6 years, HbA1c 7.4 ± 1%), treated with different insulin therapies (MDI, CSII, SAP with PLGS, HCL) were assessed before and after switching to an AHCL (MiniMed 780G, Diabeloop Roche, Tandem Control-IQ) at 1, 3, 6, and 12 months. Mixed-effects multivariable regression models were used to estimate the mean pre/post variations at different time points, adjusted for potential confounders.
A month after the switch, there was an improvement in CGM metrics and HbA1c for all patients: GRI -10.7, GMI -0.27%, CV -2.1%, TAR -3.7%, TAR -5.6%, TIR + 9.7%, HbA1c -0.54% (all p < 0.001). This improvement was maintained throughout the observational period (at 3, 6, and 12 months, with all p-values < 0.001). When improvements across the 780, Diabeloop, and Tandem CIQ devices were compared: Diabeloop demonstrated significantly better performance in terms of GRI, GMI, CV, TAR at T1 (for all p < 0.01); 780 recorded highest average decrease in TAR (p = 0.020), while Tandem achieved the most significant reduction in TBR (p = 0.004).
Adopting an AHCL leads to a rapid and sustained improvement in GRI and other parameters of metabolic control for up to a year, regardless of prior insulin therapies, baseline conditions or brands.
高级混合闭环系统（AHCL）极大地改变了 1 型糖尿病的治疗方法。本研究主要旨在评估在 1 型成年患者从四种胰岛素策略之一切换到 AHCL 时，对血糖风险指数（GRI）和其他连续血糖监测（CGM）指标的影响。
这是一项单中心、回顾性、观察前/后研究；共评估了 198 名患者（年龄 44.4 ± 12.7 岁，女性/男性 115/83，糖尿病病程 24.7 ± 11.6 年，HbA1c 7.4 ± 1%），他们在切换到 AHCL（美敦力 780G、罗氏 Diabeloop、Tandem Control-IQ）前后 1、3、6 和 12 个月时分别接受不同的胰岛素治疗（MDI、CSII、SAP 与 PLGS、HCL）。使用混合效应多变量回归模型来估计不同时间点的平均前后变化，调整潜在的混杂因素。
切换后一个月，所有患者的 CGM 指标和 HbA1c 均有所改善：GRI-10.7，GMI-0.27%，CV-2.1%，TAR-3.7%，TAR-5.6%，TIR+9.7%，HbA1c-0.54%（均 p<0.001）。这种改善在整个观察期内都保持（在 3、6 和 12 个月时，p 值均<0.001）。当比较 780、Diabeloop 和 Tandem CIQ 设备的改善情况时：在所有 p 值均<0.01）；780 记录的 TAR 平均下降最高（p=0.020），而 Tandem 实现了 TBR 的最大降幅（p=0.004）。
采用 AHCL 可在长达一年的时间内迅速且持续改善 GRI 和其他代谢控制参数，与先前的胰岛素治疗、基线情况或品牌无关。
