Continuous glucose monitoring-based time-in-range usinginsulin glargine 300 units/ml versus insulin degludec100 units/ml in type 1 diabetes the head-to-head randomizedcontrolled InRange trial b b Aim:To use continuous glucose monitoring (CGM)-based time-in-range (TIR) as a pri-mary efficacy endpoint to compare the second-generation basal insulin(BI) analogues insulin glargine 300 U/ml (Gla-300) and insulin degludec 100 U/ml(IDeg-100) in adults with type 1 diabetes (T1D).Materials and Methods:InRange was a 12-week, multicentre, randomized, active-controlled, parallel-group, open-label study comparing glucose TIR and variabilitybetween Gla-300 and IDeg-100 using blinded 20-day CGM profiles. The inclusioncriteria consisted of adults with T1D treated with multiple daily injections, using BIonce daily and rapid-acting insulin analogues for at least 1 year, with an HbA1c of7% or higher and of 10% or less at screening.Results:Overall, 343 participants were randomized: 172 received Gla-300 and 171 IDeg-100. Non-inferiority (10% relative margin)of Gla-300 versus IDeg-100 was shown for theprimary endpoint (percentage TIR≥70 to≤180 mg/dl): least squares (LS) mean (95% con-fidence interval) 52.74% (51.06%, 54.42%) for Gla-300 and 55.09% (53.34%, 56.84%) forIDeg-100; LS mean difference (non-inferiority): 3.16% (0.88%, 5.44%) (non-inferiorityP=.0067). Non-inferiority was shown on glucose total coefficient of variation (main second-ary endpoint): LS mean 39.91% (39.20%, 40.61%) and 41.22% (40.49%, 41.95%), respec-tively; LS mean difference (non-inferiority)5.44% (6.50%,4.38%) (non-inferiorityP< .0001). Superiority of Gla-300 over IDeg-100 was not shown on TIR. Occurrences ofself-measured and CGM-derived hypoglycaemia were comparable between treatmentgroups. Safety profiles were consistent with known profiles, with no unexpected findings.Conclusions:Using clinically relevant CGM metrics, InRange shows that Gla-300 isnon-inferior to IDeg-100 in people with T1D, with comparable hypoglycaemia andsafety profiles. b basal insulin continuous glucose monitoring glycaemic control insulin analogues randomized trial type 1 diabetes bazalni inzulin stalno spremljanje glukoze nadzor glikemije inzulinski analogi naključno preskušanje sladkorna bolezen tipa 1 true false false a a Angleški jezik Slovenski jezik Neznano 2025-08-11 06:20:43 2025-08-11 06:20:43 2025-08-11 06:22:08 0000-00-00 00:00:00 2023 0 0 a 545-555 str. iss. 2, [article no.] 14898 Vol. 25 2023 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 2023-01-01 2023-02-02 2023-01-01 2028-08-11 616.379 1463-1326 10.1111/dom.14898 143145987 https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14898 1 51b3dc1a-767b-11f0-80b9-50e549bee7f7 http://164.8.252.73/Dokument.php?lang=slv&id=336 https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14898 1 8300c2b3-767b-11f0-80b9-50e549bee7f7 http://164.8.252.73/Dokument.php?lang=slv&id=337 Univerza v Mariboru Intervju: E-pošta Intervju: Splet 0 0 0