{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T08:00:43Z","timestamp":1767945643651,"version":"3.49.0"},"reference-count":32,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T00:00:00Z","timestamp":1767916800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Endocrinol."],"abstract":"<jats:p>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 \u00b1 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 &amp;lt; 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 &amp;lt; 0.05). Participants in the NFI group reached glycemic targets faster than those in the CIP group (1.88 \u00b1 1.36 vs. 2.94 \u00b1 1.59 days, P &amp;lt; 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 &amp;lt; 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.<\/jats:p>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration<\/jats:title>\n                    <jats:p>identifier ChiCTR1900022412.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fendo.2025.1652388","type":"journal-article","created":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T06:40:02Z","timestamp":1767940802000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.3389","volume":"16","author":[{"given":"Jing","family":"Wang","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zibo","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lijing","family":"Jiao","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ting","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caige","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qian","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lingling","family":"Yuan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fang","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guizhi","family":"Li","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qiuxiao","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Siyao","family":"Jin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lihui","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1965","published-online":{"date-parts":[[2026,1,9]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2021.22208","article-title":"Prevalence and treatment of diabetes in China, 2013-2018","volume":"326","author":"Wang","year":"2021","journal-title":"JAMA"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-018-4557-7","article-title":"Epidemiology of diabetes and diabetic complications in China","volume":"61","author":"Ma","year":"2018","journal-title":"Diabetologia"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.2337\/dc24-er07a","article-title":"Erratum. 9. 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