Effectiveness and Safety of Insulin Glargine 300 U/ml in Comparison with Insulin Degludec 100 U/ml Evaluated with Continuous Glucose Monitoring in Adults with Type 1 Diabetes and Suboptimal Glycemic Control in Routine Clinical Practice: The OneCARE Study.

Introduction: Data regarding efficacy of second-generation basal insulins (BI) using continuous glucose monitoring (CGM) come from clinical trials. We evaluated the effectiveness of insulin glargine 300 U/ml (Gla-300) compared to insulin degludec 100 U/ml (IDeg-100) in terms of percentage of time in range (TIR); 70-180 mg/dl was obtained from CGM in sub-optimally controlled patients with type 1 diabetes (T1D) in routine clinical practice.

Methods: This observational, multicenter, cross-sectional study included patients with T1D (> 3 years diabetes duration, HbA ≥ 7.5%) who had switched from first-generation BI to Gla-300/IDeg-100 within the past 24 months according to physician discretion. Clinical and laboratory data were obtained from clinical records and during study visit, and CGM data were collected prior to the visit.

Results: One hundred ninety-nine people with T1D were included [42.6 ± 13.4 (mean ± SD) years, 18.4 ± 10.4 years diabetes duration]; 104 received Gla-300, 95 IDeg-100. TIR 70-180 throughout whole day was similar in both groups, 52.4 ± 14.0 vs. 49.3 ± 13.9% Gla-300/IDeg-100, respectively. At night, TIR 70-180 and TIR 70-140 were significantly higher in the Gla-300 group compared to the IDeg-100 (52.4 vs. 46.2 and 31.8 vs. 26.9%, respectively, p = 0.0209 and p = 0.0182), and time above range (180) was significantly lower in the Gla-300 group (40.1% vs. 47.2%, p = 0.0199). Additional CGM glucometric data were comparable in both groups. Patient treatment satisfaction score assessed through the Diabetes Treatment Satisfaction Questionnaire (DTSQ) was high and similar for both insulins.

Conclusion: This real-world study shows the effectiveness and safety of Gla-300 are more similar to than different from IDeg-100, with a slightly better nocturnal glucose profile, in sub-optimally controlled T1D patients switching from a first-generation BI.