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6 result(s) for "Scharf, Mauro"
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Time in range: a new parameter to evaluate blood glucose control in patients with diabetes
The International Consensus in Time in Range (TIR) was recently released and defined the concept of the time spent in the target range between 70 and 180 mg/dL while reducing time in hypoglycemia, for patients using Continuous Glucose Monitoring (CGM). TIR was validated as an outcome measures for clinical Trials complementing other components of glycemic control like Blood glucose and HbA1c. The challenge is to implement this practice more widely in countries with a limited health public and private budget as it occurs in Brazil. Could CGM be used intermittently? Could self-monitoring blood glucose obtained at different times of the day, with the amount of data high enough be used? More studies should be done, especially cost-effective studies to help understand the possibility of having sensors and include TIR evaluation in clinical practice nationwide.
Consensus statement on standardizing CGM evaluation metrics in Latin America: an expert approach
Background Latin America has no accepted performance standards for continuous glucose monitoring (CGM) technology evaluation. This has resulted in the emergence of various CGM devices in the market that do not meet strict quality, accuracy, reliability or safety standards. CGM systems are crucial for managing diabetes, as they provide frequent glucose measurements and help detect hypoglycemia or hyperglycemia episodes or even predict these events. Ensuring the reliability and accuracy of CGM devices is essential for patient safety. This consensus statement aims to establish a consensus-driven framework of expert recommendations regarding the metrics that should be evaluated to achieve high standards in CGM devices. Materials and methods A modified Delphi methodology was employed, engaging endocrinologists, pediatric endocrinologists and diabetologists from Latin America. Experts participated in multiple rounds of surveys and discussions to reach consensus on key characteristics measures, including accuracy thresholds, clinical validation protocols, and post-market surveillance requirements. Quantitative and qualitative data were analyzed to ensure robust recommendations. Results The expert panel identified major gaps in existing CGM regulations and established 12 key recommendations and one checklist to align Latin American standards with international best practices. These included the implementation of minimum accuracy thresholds, the adoption of standardized clinical validation protocols, and the enforcement of post-market surveillance measures. The panel also emphasized the importance of patient education, healthcare provider involvement in decision-making, and accessibility to enhance CGM adoption and usability. We underscore the necessity of these measures to improve patient outcomes, patient safety, and regulatory consistency in the region, while also enhancing CGM reliability and accuracy. Conclusion This consensus statement highlights the urgent need for a standardized metrics to evaluate CGM devices in Latin America. Implementing standardized accuracy requirements, rigorous validation protocols, and enhanced patient education will ensure device reliability, improve clinical outcomes, and foster a more equitable healthcare landscape for diabetes management in the region.
Glucose alarms approach with flash glucose monitoring system: a narrative review of clinical benefits
Attaining an adequate glycemic control has been associated with a better prognosis and with a reduction in the risk of developing long-term microvascular and macrovascular diabetic complications. Continuous glucose monitoring (CGM) has been shown to improve glycemic control and reduce blood glucose variability. Furthermore, CGM is associated with greater treatment adherence and higher satisfaction. Hypoglycemia is the most frequent acute complication in individuals with insulin treated diabetes and may limit the achievement of glycemic control. Furthermore, repeated episodes of hypoglycemia, particularly when a severe hypoglycemia event occurs are associated with adverse outcomes. The introduction of glucose alarms improves not only safety of subjects, but also contributes to improve glycemic control. However, depending on the glycemic thresholds, the frequency of alarms could be perceived as excessive, leading to a state of ‘alarm fatigue’, limiting the effective response to the alarms by the individual. The optimization of alarm thresholds tailored to individual needs and preferences can enhance the clinical utility of CGM while minimizing alarm fatigue. When alarms occur, their underlying causes should be investigated to enable appropriate corrections and adjustments. CGM systems equipped with alarms, such as FreeStyle Libre 2, have demonstrated efficacy in reducing hyperglycemia and severe hypoglycemic events, leading to improvements in time in range and quality of life of people with diabetes.
Striving for control: lessons learned from a successful international Type 1 Diabetes Youth Challenge
Aims To demonstrate whether young people with T1D using modern insulin treatment and CGM could successfully participate in extreme sport activity while maintaining good glycemic control. Methods The challenge took place in Crete/Greece over 4 days combining a long-distance trek of different levels of severity with final destination the summit of the White Mountains at 2080 m. Eleven participants (5/6 female/male, age 18.2 ± 1.3 years, T1D duration 7.9 ± 3.5 years, HbA1c 7.3 ± .7% (56 ± 16 mmol/mol); mean ± SD) from 11 SWEET centers in Belgium, Brazil, Canada, Germany, Greece, France, India, Italy, Portugal, Slovenia and Sweden participated to the challenge. Five participants were on CSII, six on MDI; all were wearing a continuous glucose monitoring system. The glycemic targets during trekking were defined as 80–180 mg/dl (4.4–10 mmol/l). Results All participants completed the challenge. In total, the group walked 54.5 km under varying climate conditions (temperature 14–35 °C). During the challenge, insulin requirements decreased significantly compared to baseline: total daily insulin by 31.1 ± 16.7% ( p  < .001), basal by 30.8 ± 14.9% ( p  < .001), and prandial by 32.5 ± 28.0% ( p  = .023), with no differences between participants with CSII or MDI. No episode of severe hypoglycemia or DKA occurred. Mean glucose levels were 170.7 ± 60.1 mg/dl with 61.5 ± 18.7% of CGM values in the target range, 5.4 ± 5.4% under 80 mg/dl and 32.8 ± 16.6% above 180 mg/dl. Conclusions The results of this SWEET Initiative activity demonstrated that well-educated adolescents and young adults with T1D using modern insulin treatments are able to perform successfully even extraordinary physical challenges while maintaining good glycemic control without diabetes-related acute complications.