CLINICAL TRIAL article
Front. Endocrinol.
Sec. Clinical Diabetes
This article is part of the Research TopicTechnologies for Diabetes, volume IIIView all 12 articles
Efficacy and safety of needle-free injection in patients with type 2 diabetes mellitus undergoing intensive insulin therapy: a randomized controlled trial based on the flash glucose monitoring system
Provisionally accepted
Jing WangZibo LiuLijing JiaoJing ZhouTing WangCaige LiQian WangLingling YuanFang ZhangGuizhi LiQiuxiao ZhuSiyao Jin
Lihui Zhang*- Second Hospital of Hebei Medical University, Shijiazhuang, China
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This randomized, open-label, parallel-controlled trial investigated the efficacy and safety of needle-free injection (NFI) compared to conventional insulin pen (CIP) in patients with type 2 diabetes mellitus (T2DM) undergoing intensive insulin therapy. A total of 64 hospitalized patients were randomly assigned to receive either NFI or CIP as part of a basal-bolus insulin regimen for 12±2 days. Glycemic parameters were continuously monitored using a flash glucose monitoring (FGM) system. The NFI group showed significantly greater reductions in fasting plasma glucose (FPG) and 2-hour postprandial glucose (2hPPG), along with a more pronounced increase in serum 1,5-anhydroglucitol (1,5-AG) levels compared to the CIP group (all P < 0.05). Glycemic variability was also reduced in the NFI group, as indicated by higher time in range (TIR) and lower mean amplitude (MAGE) and largest amplitude (LAGE) of glycemic excursions (P < 0.05). Participants in the NFI group reached glycemic targets faster than those in the CIP group (1.88±1.36 vs. 2.94±1.59 days, P < 0.05), while daily insulin requirements remained comparable. Furthermore, the NFI group reported fewer injection-site adverse reactions, significantly lower pain scores, and higher treatment satisfaction (P < 0.001), with no increase in hypoglycemic events. These findings suggest that needle-free injection is a safe and effective alternative to conventional insulin delivery in hospitalized patients with T2DM, offering improved glycemic control, reduced glucose variability, and enhanced treatment experience. Trial registration: ChiCTR1900022412.
Keywords: 1,5-Anhydroglucitol, BloodGlucoseFluctuation, Diabetes Mellitus, efficacy and safety, flashglucosemonitoringsystem, intensive insulin therapy, Needle-FreeInjector, type 2
Received: 23 Jun 2025; Accepted: 30 Nov 2025.
Copyright: © 2025 Wang, Liu, Jiao, Zhou, Wang, Li, Wang, Yuan, Zhang, Li, Zhu, Jin and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Lihui Zhang
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