Despite the availability of new classes of glucose-lowering drugs that improve glycaemic levels and minimise long-term complications, at least 20–25% of people with type 2 diabetes require insulin therapy. Moreover, a substantial proportion of these individuals do not achieve adequate metabolic control following insulin initiation. This is due to several factors: therapeutic inertia, fear of hypoglycaemia and/or weight gain, poor communication, complexity of insulin titration, and the number of injections needed, with the associated reduced adherence to insulin therapy. Once-weekly insulins provide a unique opportunity to simplify basal insulin therapy and to allow good glycaemic control with a low risk of hypoglycaemia. Several approaches to developing a stable and effective once-weekly insulin have been proposed, but, to date, insulin icodec and basal insulin Fc (insulin efsitora alfa) are the only two formulations for which clinical studies have been reported. The results of Phase I and II studies emphasise both efficacy (in term of glucose levels) and potential risks and adverse events. Phase III studies involving insulin icodec are reassuring regarding the risk of hypoglycaemia compared with daily basal insulin analogues. Despite some concerns raised in ongoing clinical trials, the available data suggest that weekly insulins may also be an option for individuals with type 1 diabetes, especially when adherence is suboptimal. For the first time there is an opportunity to make an important breakthrough in basal insulin therapy, particularly in people with type 2 diabetes, and to improve not only the quality of life of people with diabetes, but also the practice of diabetologists. Graphical Abstract
Intermittently Scanned Continuous Glucose Monitoring (isCGM) devices are increasingly being used in patients with type 2 diabetes mellitus (T2DM) on insulin therapy for their benefits regarding disease management. Evidence of isCGM use in patients with T2DM on basal or non-insulin therapy is lacking. This study aimed at assessing the efficacy and safety of isCGM in this population. This was an observational, retrospective, real-world study enrolling patients with T2DM who were starting the use of isCGM. Data from medical records (i.e., demographics, clinical characteristics, laboratory assessments, and isCGM metrics) were collected over three time periods (baseline, 3 and 6 months). The endpoints were glycated haemoglobin (HbA1c) changes and changes in isCGM metrics as defined by the International Consensus from baseline to 3 months and 6 months. Overall, 132 patients were included (69.5% male; mean age 68.2 ± 11.0 years; mean disease duration 19.0 ± 9.4 years; 79.7% on basal insulin ±non-insulin therapy; mean baseline HbA1c 8.1% ± 1.3%). The estimated mean change in HbA1c was statistically significant at three (−0.4 ± 1.0%; p = 0.003) and six months (−0.6 ± 1.3%; p < 0.0001). In conclusion, isCGM proved to be effective and safe in improving glycaemic control in patients with T2DM on basal insulin or non-insulin therapy.
Background: Advanced hybrid closed-loop (aHCL) systems have improved glycemic control in individuals with type 1 diabetes (T1DM). However, it remains unclear whether their efficacy and safety differ by patient’s sex, in view of known sex-related physiological and behavioral differences in disease control and management. Methods: This retrospective, single-center study included 176 adults with T1DM starting aHCL therapy with Medtronic MiniMed™ 780G. Continuous glucose monitoring (CGM) metrics, glycated hemoglobin (HbA1c), and glycemic variability (GV) indexes were collected at baseline, 6 months, and 12 months after starting aHCL therapy. Only patients with at least 70% sensor usage were included at each time point. The primary outcome was the assessment of sex-related differences in CGM metrics at 12 months. Secondary outcomes included changes in HbA1c and GV indexes by sex and over time. Results: TIR increased significantly at 6 (+6.6%, p < 0.001) and 12 months (+5.4%, p < 0.001), TAR decreased, and TBR remained stable. HbA1c was significantly reduced at both 6 and 12 months (−0.6%, p < 0.001). Improvements were consistent in both males and females, with females exhibiting better improvement in HbA1c compared to males (−0.4%, p = 0.049). No significant sex differences were found in CGM metrics at 12 months. GV indexes improved significantly in both groups, regardless of sex. At the multivariable analysis, only HbA1c 70%, TBR < 4%, HbA1c < 7.0%). Conclusions: aHCL therapy improved glycemic control and GV in adults with T1DM, regardless of the patient’s sex. These results support the generalizability of aHCL therapy and underscore the need to ensure equitable access to technologies rather than sex-specific adjustments.
1 January 1990 in Pathophysiology of Haemostasis and Thrombosis
Intermittently Scanned Continuous Glucose Monitoring (isCGM) devices are increasingly being used in patients with type 2 diabetes mellitus (T2DM) on insulin therapy for their benefits regarding disease management. Evidence of isCGM use in patients with T2DM treated with basal insulin or oral antidiabetic drugs is lacking. The aim of this study was to assess the efficacy and safety of isCGM in this population. This was an observational, retrospective, real-world study enrolling patients with T2DM who were starting with the use of isCGM. Data from medical records (i.e. demographics, clinical characteristics, laboratory assessments, and isCGM metrics) were collected over three time periods (baseline, 3 and 6 months). The endpoints were glycated haemoglobin (HbA1c) changes, and changes in isCGM metrics as defined by the International Consensus from baseline to a 3-month and a 6-month follow-up. Overall, 132 patients were included (69% male; mean age 68.2±11.0 years; mean disease duration 19.0±9.3 years; 80% on basal insulin ± oral drugs at baseline; mean baseline HbA1c 8.1%±1.3%). The estimated mean change in HbA1c from baseline was statistically significant at three (-0.4±1.0%; p=0.003) and at six months (-0.6±1.3%; p<0.0001). No statistical differences were found in the mean change of the isCGM metrics. Intermittently Scanned Continuous Glucose Monitoring is effective and safe in improving glycaemic control in patients with type 2 diabetes treated with basal insulin or oral antidiabetic drugs.
5 June 2025 in European Journal of Internal Medicine