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Aim: To evaluate the risk of all-cause and cardiovascular mortality, acute myocardial infarction, and stroke associated with insulin treatment in patients with type 2 diabetes., Methods: A systematic review with meta-analysis of randomized clinical trials (RCTs) was performed. EMBASE, Cochrane, and PubMed databases were searched for RCTs reporting mortality or cardiovascular events and comparing basal insulin to any treatment in patients with type 2 diabetes. Data were summarized with Mantel-Haenzel relative risk (RR). Trial sequential analysis (TSA) was used to evaluate the reliability of the results considering a 20% relative risk difference between treatments. PROSPERO Registry: CRD42018087336., Results: In total, 2351 references were identified, and 26 studies (24348 patients) were included. Most studies evaluated glargine insulin (69%), compared insulin to GLP-1 analogs (57%), and evaluated add-on therapy with metformin (77%). Insulin was not associated with increased all-cause mortality (RR 0.99; 95% confidence interval (CI) 0.92-1.06), cardiovascular mortality (RR 1.01; 95% CI 0.91-1.13), myocardial infarction (RR 1.02; 95% CI 0.92-1.15), or stroke (RR 0.87; 95% CI 0.68-1.12). Insulin treatment increased severe hypoglycemia risk (RR 2.98; 95% CI 2.47-3.61). All analyses had low statistical heterogeneity. TSA confirmed these findings: optimal sample size (myocardial infarction), futility boundary (all-cause mortality, cardiovascular mortality, and stroke) and harm boundary (hypoglycemia) were reached., Conclusion: Treatment with basal insulin of patients with type 2 diabetes does not increase the risk of cardiovascular events or death. Despite the increased risk of hypoglycemia, these findings reinforce that insulin is a safe option in the treatment of type 2 diabetes., Competing Interests: Declaration of Competing Interests The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JLG reports grants from Conselho Nacional de Desenvolvimento Científico e Tecnológico, during the conduct of the study; grants and other from Eli Lilly, grants from Bristol-Myers Squibb, grants and other from Boehringer Ingelheim, grants from GlaxoSmithKline, grants and other from Novo Nordisk, grants from Janssen, all outside the submitted work; CBL was a recipient of a scholarship grant from CNPq; no other relationships or activities that could appear to have influenced the submitted work are reported., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Aims: Systematic review and meta-analysis to evaluate the effect of Self-Monitoring of Blood Glucose (SMBG) on glycemic control in patients with type 2 Diabetes (T2D)., Methods: We searched the Medline, Embase, Cochrane Central, and ClinicalTrials.gov databases up to 20 July 2017. We also performed a manual search of abstracts from recent meetings of the American Diabetes Association and the European Association for the Study of Diabetes., Study Selection: randomized controlled trials (RCTs) conducted in patients with T2D comparing any kind of SMBG to a control group. Two independent reviewers assessed the eligibility of references. Influence of SMBG in glycated hemoglobin (HbA1c) was aggregated as weighted mean difference accessed by direct random effect meta-analyses at 12, 24 weeks and 1 year. Sub-analyses were made to assess the effects of previous glycemic control and number of tests performed., Results: SMBG was associated with a reduction of HbA1c at 12 weeks (-0.31%; 95% CI: -0.57 to -0.05) and 24 weeks (-0.34%; 95%CI: -0.52 to -0.17), but no difference was found for 1 year. Subgroup analysis including studies with baseline HbA1c greater than 8% showed a higher reduction of HbA1c: -0.83% (95% CI: -1.55 to -0.11) at 12 weeks, and -0.48% (95% CI: -0.77 to -0.19) at 24 weeks, with no difference for 1 year nor for the stratification for number the tests., Conclusion: SMBG seems to lead to a slightly better glycemic control in the short term in patients with T2D. Patients decompensated at baseline appear to have the greatest benefit. PROSPERO register: CRD42016033558., (Copyright © 2018 Elsevier B.V. All rights reserved.)