Roy W. Beck团队揭示了2型糖尿病患者自动胰岛素输送的随机试验。相关论文于2025年3月19日发表在《新英格兰医学杂志》上。

背景:自动化胰岛素输送（AID）系统已被证明对1型糖尿病患者有益，但关于其在胰岛素治疗的2型糖尿病管理中的作用，还需要随机对照试验的数据。

方法:在这项为期13周的多中心试验中，胰岛素治疗的2型糖尿病成人患者以2:1的比例随机分配接受AID或继续其试验前胰岛素递送方法（对照组）；两组均接受连续血糖监测（CGM）。主要终点是13周时的糖化血红蛋白水平。

结果:共有319名患者接受随机分组。AID组糖化血红蛋白水平下降了0.9个百分点（从基线时的8.2±1.4%降至第13周时的7.3±0.9%），对照组下降了0.3个百分点（从8.1±1.2%降至7.7±1.1%）(调整后的平均差异为-0.6个百分点；95%置信区间为-0.8 ~ -0.4；术中,0.001)。AID组患者血糖在目标范围70 ~ 180mg /分升的平均时间百分比从48±24%增加到64±16%，对照组从51±21%增加到52±21%(平均差异14个百分点；95% CI, 11 ~ 17；术中,0.001)。所有其他反映高血糖的多重对照CGM结果在AID组明显好于对照组。两组患者cgm测量的低血糖发生率均较低。AID组1例患者发生严重低血糖事件。

研究结果表明，在这项为期13周的随机对照试验中，纳入胰岛素治疗的2型糖尿病成人患者，AID与单独使用CGM相比，糖化血红蛋白水平的降低幅度更大。

附：英文原文

Title: A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes

Author: Yogish C. Kudva, Dan Raghinaru, John W. Lum, Timothy E. Graham, David Liljenquist, Elias K. Spanakis, Francisco J. Pasquel, Andrew Ahmann, David T. Ahn, Grazia Aleppo, Thomas Blevins, Davida Kruger, Sue A. Brown, Carol J. Levy, Ruth S. Weinstock, Devin W. Steenkamp, Tamara Spaic, Irl B. Hirsch, Frances Broyles, Michael R. Rickels, Michael A. Tsoukas, Philip Raskin, Betul Hatipoglu, Donna Desjardins, Adrienne N. Terry, Lakshmi G. Singh, Georgia M. Davis, Caleb Schmid, Jelena Kravarusic, Kasey Coyne, Luis Casaubon, Valerie Espinosa, Jaye K. Jones, Kathleen Estrada, Samina Afreen, Camilla Levister, Grenye O’Malley, Selina L. Liu, Sheryl Marks, Amy J. Peleckis, Melissa-Rosina Pasqua, Vanessa Tardio, Corey Kurek, Ryan D. Luker, Jade Churchill, Farbod Z. Tajrishi, Ariel Dean, Brittany Dennis, Evelyn Fronczyk, Jennifer Perez, Shereen Mukhashen, Jasmeen Dhillon, Aslihan Ipek, Suzan Bzdick, Astrid Atakov Castillo, Marsha Driscoll, Xenia Averkiou, Cornelia V. Dalton–Bakes, Adelyn Moore, Lin F. Jordan, Amanda Lesniak, Jordan E. Pinsker, Ravid Sasson-Katchalski, Tiffany Campos, Charles Spanbauer, Lauren Kanapka, Craig Kollman, Roy W. Beck

Issue&Volume: 2025-03-19

Abstract: BACKGROUND

Automated insulin delivery (AID) systems have been shown to be beneficial for patients with type 1 diabetes, but data are needed from randomized, controlled trials regarding their role in the management of insulin-treated type 2 diabetes.

METHODS

In this 13-week, multicenter trial, adults with insulin-treated type 2 diabetes were randomly assigned in a 2:1 ratio to receive AID or to continue their pretrial insulin-delivery method (control group); both groups received continuous glucose monitoring (CGM). The primary outcome was the glycated hemoglobin level at 13 weeks.

RESULTS

A total of 319 patients underwent randomization. Glycated hemoglobin levels decreased by 0.9 percentage points (from 8.2±1.4% at baseline to 7.3±0.9% at week 13) in the AID group and by 0.3 percentage points (from 8.1±1.2% to 7.7±1.1%) in the control group (mean adjusted difference, –0.6 percentage points; 95% confidence interval [CI], –0.8 to –0.4; P<0.001). The mean percentage of time that patients were in the target glucose range of 70 to 180 mg per deciliter increased from 48±24% to 64±16% in the AID group and from 51±21% to 52±21% in the control group (mean difference, 14 percentage points; 95% CI, 11 to 17; P<0.001). All other multiplicity-controlled CGM outcomes reflective of hyperglycemia that were measured were significantly better in the AID group than in the control group. The frequency of CGM-measured hypoglycemia was low in both groups. A severe hypoglycemia event occurred in one patient in the AID group.

CONCLUSIONS

In this 13-week, randomized, controlled trial involving adults with insulin-treated type 2 diabetes, AID was associated with a greater reduction in glycated hemoglobin levels than CGM alone.

DOI: NJ202503190000001

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2415948