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BACKGROUND: Continuous glucose monitoring systems are increasingly being adopted as an alternative to self-monitoring of blood glucose (SMBG) by persons with diabetes mellitus receiving insulin therapy. MAIN BODY: The FreeStyle Libre flash glucose monitoring system (Abbott Diabetes Care, Witney, United Kingdom) consists of a factory-calibrated sensor worn on the back of the arm which measures glucose levels in the interstitial fluid every minute and stores the reading automatically every 15 min. Swiping the reader device over the sensor retrieves stored data and displays current interstitial glucose levels, a glucose trend arrow, and a graph of glucose readings over the preceding 8 h. In patients with type 2 diabetes (T2D) receiving insulin therapy, pivotal efficacy data were provided by the 6-month REPLACE randomized controlled trial (RCT) and 6-month extension study. Compared to SMBG, the flash system significantly reduced the time spent in hypoglycemia and frequency of hypoglycemic events, although no significant change was observed in glycosylated hemoglobin (HbA1c) levels. Subsequent RCTs and real-world chart review studies have since shown that flash glucose monitoring significantly reduces HbA1c from baseline. Real-world studies in both type 1 diabetes or T2D populations also showed that flash glucose monitoring improved glycemic control. Higher (versus lower) scanning frequency was associated with significantly greater reductions in HbA1c and significant improvements in other measures such as time spent in hypoglycemia, time spent in hyperglycemia, and time in range. Additional benefits associated with flash glucose monitoring versus SMBG include reductions in acute diabetes events, all-cause hospitalizations and hospitalized ketoacidosis episodes; improved well-being and decreased disease burden; and greater treatment satisfaction. CONCLUSION: T2D patients who use flash glucose monitoring might expect to achieve significant improvement in HbA1c and glycemic parameters and several associated benefits.
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BACKGROUND: New technologies are changing diabetes treatment and contributing better outcomes in developed countries. To our knowledge, no previous studies have investigated the comparative effect of sensor-based monitoring on glycemic markers in developing countries like Brazil. The present study aims to evaluate the use of intermittent Continuous Glucose Measurements (iCGM) in a developing country, Brazil, regarding (i) frequency of glucose scans, (ii) its association with glycemic markers and (iii) comparison with these findings to those observed in global population data. METHODS: Glucose results were de-identified and uploaded to a dedicated database when Freestyle Libre™ readers were connected to an internet-ready computer. Data between September 2014 and Dec 2018, comprising 688,640 readers and 7,329,052 sensors worldwide, were analysed (including 17,691 readers and 147,166 sensors from Brazil). Scan rate per reader was determined and each reader was sorted into 20 equally-sized rank ordered groups, categorised by scan frequency. Glucose parameters were calculated for each group, including estimated A1c, time above, below and within range identified as 70-180 mg/dL. RESULTS: In Brazil, reader users performed an average of 14 scans per day, while around the world, reader users performed an average of 12 scans per day (p < 0.01). In Brazil dataset, those in the lowest and in the highest groups scanned on average 3.6 and 43.1 times per day had an estimated A1c of 7.56% (59 mmol/mol) and 6.71% (50 mmol/mol), respectively (p < 0.01). Worldwide, the lowest group and the highest groups scanned 3.4 times/day and 37.8 times/day and had an eA1c of 8.14% (65 mmol/mol) and 6.70% (50 mmol/mol), respectively (p < 0.01). For the scan groups in both populations, the time spent above 180 mg/dL decreased as the scan frequency increased. In both Brazil and around the world, as scan frequency increased, time in range (TIR) increased. In Brazil, TIR increased from 14.15 to 16.62 h/day (p < 0.01). Worldwide, TIR increased from 12.06 to 16.97 h/day (p < 0.01). CONCLUSIONS: We conclude that Brazilian users have a high frequency of scans, more frequent than global data. Similarly to the world findings, increased scan frequency is associated with better glycemic control.
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BACKGROUND: This post hoc analysis examined the efficacy and safety of twice-daily insulin lispro low mixture (LM25) and once-daily basal insulin glargine plus once-daily prandial insulin lispro (IGL) in a Latin American subpopulation with type 2 diabetes mellitus (T2DM). METHODS: A phase 4, randomized, open-label, parallel-arm trial included participants aged 18-75 years with T2DM taking once-daily insulin glargine and stable doses of metformin and/or pioglitazone with glycated hemoglobin (HbA1c) 7.5-10.5 % and fasting plasma glucose ≤121 mg/dL. Participants were randomized 1:1 to receive their stable dose of metformin and/or pioglitazone plus twice-daily LM25 or IGL for 24 weeks. The primary efficacy outcome was change in HbA1c after 24 weeks of treatment. Results from participants in Argentina, Brazil, and Mexico are presented here. RESULTS: 162 participants (80 LM25; 82 IGL) with mean ± standard deviation (SD) age = 57.3 ± 9.0 years and body mass index = 31.3 ± 5.2 kg/m(2) were included. Mean ± SD change in HbA1c from baseline to week 24 was -1.5 ± 1.0 % (LM25) and -1.1 ± 1.2 % (IGL). At week 24, 35.1 % (LM25) and 31.6 % (IGL) of participants achieved HbA1c <7.0 %. Mean ± SD weight gain from baseline to week 24 was 2.4 ± 2.9 kg in the LM25 group and 1.0 ± 3.1 kg in the IGL group. The mean ± SD rates of total hypoglycemia per year were 18.9 ± 27.3 (LM25) and 21.6 ± 31.1 (IGL). Rates of treatment-emergent adverse events were 46 % (LM25) and 39 % (IGL). CONCLUSIONS: Our results suggest that both LM25 and IGL are viable treatment options for insulin intensification in Latin American patients with T2DM with suboptimal glycemic control on basal insulin glargine. The safety and tolerability profiles of LM25 and IGL are consistent between this Latin American population and the global trial-level population. Trial registration NCT01175824.
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Os autores apresentam um ensaio clínico, randomizado, envolvendo 27 pacientes adultos, submetidos à terapia anti-hipertensiva com betabloqueadores, com o objetivo de identificar a existência de correlaçäo entre os achados eletrocardiográficos e o estabelecimento do betabloqueio. Foram avaliadas as seguintes variáveis: freqüência cardíaca, duraçäo do complexo QRS e duraçäo dos intervalos P-R e Q-Tc, antes do início do tratamento e após 90 dias da instauraçäo de terapêutica betabloqueadora. Os resultados encontrados näo demonstraram alteraçöes significativas (p>0,05) na amostra estudada, sugerindo que os parâmetros eletrocardiográficos de betabloqueio apontados pela literatura näo se constituem condiçöes indispensáveis ao sucesso terapêutico.