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Povzetek: 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.
Ključne besede: basal insulin, continuous glucose monitoring, glycaemic control, insulin analogues, randomized trial, type 1 diabetes
Objavljeno v DiRROS: 27.08.2026; Ogledov: 163; Prenosov: 143
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Povzetek: Type 1 diabetes (T1D) is a chronic autoimmune disease that results in loss of insulin-secreting pancreatic β-cells in the islets of Langerhans. A diagnosis of T1D is typically associated with children and adolescents, yet half of all diagnoses of T1D are made in adults. In children and adolescents, T1D is often first recognized following hospitalization for diabetic ketoacidosis (DKA), which occurs in approximately 20%-50% of new-onset T1D for people younger than 18 years of age in Europe. For adults with new-onset T1D, DKA rates of up to 24% are estimated. Early-stage T1D, during the asymptomatic period, can be detected through screening for multiple islet autoantibodies in blood samples, including capillary and venous samples, and such programs are made more popular by the availability of disease-modifying therapies for early-stage T1D. For individuals who screen positive for early-stage T1D, participation in monitoring programs can greatly reduce the incidence of DKA once symptomatic hyperglycemia develops, as well as reducing severity of symptoms of T1D at onset. Education and awareness of the clinically relevant features of symptomatic T1D can also support the psychological wellbeing of people with early-stage T1D and minimize distress at the point when insulin treatment is necessary. All of these consequences come with a predicted reduced burden of healthcare costs for managing T1D at a population level, and general population screening for islet autoantibodies is underway. In this European perspective, we discuss the imperatives and the components of implementation of general population screening for early-stage T1D.
Ključne besede: autoimmunity, beta cell function, glycaemic control, health economics, islets, type 1 diabetes
Objavljeno v DiRROS: 23.04.2026; Ogledov: 467; Prenosov: 527
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