Dataset Information

Intensive glycaemic control for patients with type 2 diabetes: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials.

ABSTRACT:

Objective

To assess the effect of targeting intensive glycaemic control versus conventional glycaemic control on all cause mortality and cardiovascular mortality, non-fatal myocardial infarction, microvascular complications, and severe hypoglycaemia in patients with type 2 diabetes.

Design

Systematic review with meta-analyses and trial sequential analyses of randomised trials.

Data sources

Cochrane Library, Medline, Embase, Science Citation Index Expanded, LILACS, and CINAHL to December 2010; hand search of reference lists and conference proceedings; contacts with authors, relevant pharmaceutical companies, and the US Food and Drug Administration.

Study selection

Randomised clinical trials comparing targeted intensive glycaemic control with conventional glycaemic control in patients with type 2 diabetes. Published and unpublished trials in all languages were included, irrespective of predefined outcomes.

Data extraction

Two reviewers independently assessed studies for inclusion and extracted data related to study methods, interventions, outcomes, risk of bias, and adverse events. Risk ratios with 95% confidence intervals were estimated with fixed and random effects models.

Results

Fourteen clinical trials that randomised 28,614 participants with type 2 diabetes (15,269 to intensive control and 13,345 to conventional control) were included. Intensive glycaemic control did not significantly affect the relative risks of all cause (1.02, 95% confidence interval 0.91 to 1.13; 28,359 participants, 12 trials) or cardiovascular mortality (1.11, 0.92 to 1.35; 28,359 participants, 12 trials). Trial sequential analyses rejected a relative risk reduction above 10% for all cause mortality and showed insufficient data on cardiovascular mortality. The risk of non-fatal myocardial infarction may be reduced (relative risk 0.85, 0.76 to 0.95; P=0.004; 28,111 participants, 8 trials), but this finding was not confirmed in trial sequential analysis. Intensive glycaemic control showed a reduction of the relative risks for the composite microvascular outcome (0.88, 0.79 to 0.97; P=0.01; 25,600 participants, 3 trials) and retinopathy (0.80, 0.67 to 0.94; P=0.009; 10,793 participants, 7 trials), but trial sequential analyses showed that sufficient evidence had not yet been reached. The estimate of an effect on the risk of nephropathy (relative risk 0.83, 0.64 to 1.06; 27,769 participants, 8 trials) was not statistically significant. The risk of severe hypoglycaemia was significantly increased when intensive glycaemic control was targeted (relative risk 2.39, 1.71 to 3.34; 27,844 participants, 9 trials); trial sequential analysis supported a 30% increased relative risk of severe hypoglycaemia.

Conclusion

Intensive glycaemic control does not seem to reduce all cause mortality in patients with type 2 diabetes. Data available from randomised clinical trials remain insufficient to prove or refute a relative risk reduction for cardiovascular mortality, non-fatal myocardial infarction, composite microvascular complications, or retinopathy at a magnitude of 10%. Intensive glycaemic control increases the relative risk of severe hypoglycaemia by 30%.

SUBMITTER: Hemmingsen B

PROVIDER: S-EPMC3223424 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Publications

Intensive glycaemic control for patients with type 2 diabetes: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials.

Hemmingsen Bianca B Lund Søren S SS Gluud Christian C Vaag Allan A Almdal Thomas T Hemmingsen Christina C Wetterslev Jørn J

BMJ (Clinical research ed.) 20111124

<h4>Objective</h4>To assess the effect of targeting intensive glycaemic control versus conventional glycaemic control on all cause mortality and cardiovascular mortality, non-fatal myocardial infarction, microvascular complications, and severe hypoglycaemia in patients with type 2 diabetes.<h4>Design</h4>Systematic review with meta-analyses and trial sequential analyses of randomised trials.<h4>Data sources</h4>Cochrane Library, Medline, Embase, Science Citation Index Expanded, LILACS, and CINAH ...[more]

PMID: 22115901

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Project description:ObjectiveTo assess the benefits and harms of targeting intensive versus conventional glycaemic control in patients with type 1 diabetes mellitus.DesignA systematic review with meta-analyses and trial sequential analyses of randomised clinical trials.Data sourcesThe Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded and LILACS to January 2013.Study selectionRandomised clinical trials that prespecified different targets of glycaemic control in participants at any age with type 1 diabetes mellitus were included.Data extractionTwo authors independently assessed studies for inclusion and extracted data.Results18 randomised clinical trials included 2254 participants with type 1 diabetes mellitus. All trials had high risk of bias. There was no statistically significant effect of targeting intensive glycaemic control on all-cause mortality (risk ratio 1.16, 95% CI 0.65 to 2.08) or cardiovascular mortality (0.49, 0.19 to 1.24). Targeting intensive glycaemic control reduced the relative risks for the composite macrovascular outcome (0.63, 0.41 to 0.96; p=0.03), and nephropathy (0.37, 0.27 to 0.50; p<0.00001. The effect estimates of retinopathy, ketoacidosis and retinal photocoagulation were not consistently statistically significant between random and fixed effects models. The risk of severe hypoglycaemia was significantly increased with intensive glycaemic targets (1.40, 1.01 to 1.94). Trial sequential analyses showed that the amount of data needed to demonstrate a relative risk reduction of 10% were, in general, inadequate.ConclusionsThere was no significant effect towards improved all-cause mortality when targeting intensive glycaemic control compared with conventional glycaemic control. However, there may be beneficial effects of targeting intensive glycaemic control on the composite macrovascular outcome and on nephropathy, and detrimental effects on severe hypoglycaemia. Notably, the data for retinopathy and ketoacidosis were inconsistent. There was a severe lack of reporting on patient relevant outcomes, and all trials had poor bias control.

Project description:ObjectiveTo determine whether psychological interventions have any effect on glycaemic control in people with type 1 diabetes.DesignSystematic review and meta-analysis of psychological therapies to assess their effectiveness in improving glycaemic control in type 1 diabetes.Data sourcesMedline, PsycINFO, Embase, and Cochrane central register of controlled trials searched to September 2004.Review methodsAll included studies were randomised controlled trials in children (including adolescents) or adults with type 1 diabetes that evaluated the effect of a psychological therapy (counselling, cognitive behaviour therapy, family systems therapy, and psychodynamic therapy) on control of diabetes. Data were extracted on sample size, age, duration of diabetes, type of psychological therapy, its mode of delivery, and type of intervention in control group.Main outcome measuresGlycaemic control measured by percentage of glycated haemoglobin and psychological distress. Pooled standardised effect sizes were calculated.Results29 trials were eligible for the systematic review and 21 trials for the meta-analysis. In the 10 studies of children and adolescents included in the meta-analysis, the mean percentage of glycated haemoglobin was significantly reduced in those who had received a psychological intervention compared with those in the control group (pooled standardised mean difference -0.35 (95% confidence interval -0.66 to -0.04), equivalent to a 0.48% (0.05% to 0.91%) absolute reduction in glycated haemoglobin. In the 11 studies in adults the pooled standardised mean difference was -0.17 (-0.45 to 0.10), equivalent to 0.22% (-0.13% to 0.56%) absolute reduction in glycated haemoglobin. Psychological distress was significantly lower in the intervention groups in children and adolescents (pooled standardised effect size -0.46, -0.83 to -0.10) but not in adults (-0.25, -0.51 to 0.01).ConclusionPsychological treatments can slightly improve glycaemic control in children and adolescents with diabetes but have no effect in adults.

Project description:ObjectiveTo inform the update of the European Association for the Study of Diabetes clinical practice guidelines for nutrition therapy.DesignSystematic review and meta-analysis of randomised controlled trials.Data sourcesMedline, Embase, and the Cochrane Library searched up to 13 May 2021.Eligibility criteria for selecting studiesRandomised controlled trials of three or more weeks investigating the effect of diets with low glycaemic index (GI)/glycaemic load (GL) in diabetes.Outcome and measuresThe primary outcome was glycated haemoglobin (HbA1c). Secondary outcomes included other markers of glycaemic control (fasting glucose, fasting insulin); blood lipids (low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), non-HDL-C, apo B, triglycerides); adiposity (body weight, BMI (body mass index), waist circumference), blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)), and inflammation (C reactive protein (CRP)).Data extraction and synthesisTwo independent reviewers extracted data and assessed risk of bias. Data were pooled by random effects models. GRADE (grading of recommendations assessment, development, and evaluation) was used to assess the certainty of evidence.Results29 trial comparisons were identified in 1617 participants with type 1 and 2 diabetes who were predominantly middle aged, overweight, or obese with moderately controlled type 2 diabetes treated by hyperglycaemia drugs or insulin. Low GI/GL dietary patterns reduced HbA1c in comparison with higher GI/GL control diets (mean difference −0.31% (95% confidence interval −0.42 to −0.19%), P<0.001; substantial heterogeneity, I2=75%, P<0.001). Reductions occurred also in fasting glucose, LDL-C, non-HDL-C, apo B, triglycerides, body weight, BMI, systolic blood pressure (dose-response), and CRP (P<0.05), but not blood insulin, HDL-C, waist circumference, or diastolic blood pressure. A positive dose-response gradient was seen for the difference in GL and HbA1c and for absolute dietary GI and SBP (P<0.05). The certainty of evidence was high for the reduction in HbA1c and moderate for most secondary outcomes, with downgrades due mainly to imprecision.ConclusionsThis synthesis suggests that low GI/GL dietary patterns result in small important improvements in established targets of glycaemic control, blood lipids, adiposity, blood pressure, and inflammation beyond concurrent treatment with hyperglycaemia drugs or insulin, predominantly in adults with moderately controlled type 1 and type 2 diabetes. The available evidence provides a good indication of the likely benefit in this population.Study registrationClinicalTrials.gov NCT04045938.

Project description:BackgroundGlobally, type 2 diabetes has continued to increase, now accounting for over 90% of all diabetes cases. Though the magnitude of uncontrolled glycaemic levels in patients with type 2 diabetes is steadily rising, evidence showed that effectively controlled glycaemic levels can prevent complications and improve the quality of life of these patients. As little is known about the effect of educational interventions on this population, this systematic review and meta-analysis evaluated the effectiveness of educational interventions versus standard care on glycaemic control and disease knowledge among patients with type 2 diabetes.MethodsPubMed, Google Scholar, Cochrane Library, Scopus, African Journals Online and Wiley Online Library were searched. Two authors independently assessed within-trial risk of bias in each included study using revised Cochrane risk-of-bias tool for randomised trials. A random-effects model was employed to estimate combined effect sizes. Subgroup analyses were employed to investigate possible sources of heterogeneity between studies. The overall certainty of the evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.ResultsA total of 19 trials with 2708 study participants were included in the review. Primary outcomes (glycaemic control) were reported in 18 trials. The pooled estimated impact of educational intervention on glycaemic levels using the random-effects model was -0.83 (95% CI: -1.17 to -0.49, p<0.001). Subgroup analyses revealed greater A1c reductions in those studies with intervention duration of up to 3 months and with empirical intervention designs. Educational interventions led to significant increases in participants' knowledge of type 2 diabetes (standardised mean difference: 1.16; 95% CI: 0.71 to 1.60; I2=93%).ConclusionIn the current review overall, educational interventions can potentially lead to improved glycaemic control levels in patients with type 2 diabetes despite heterogeneity across the studies. Besides, the findings showed that educational interventions could increase disease knowledge among patients with type 2 diabetes.Prospero registration numberCRD42020205838.

Dataset Information

Intensive glycaemic control for patients with type 2 diabetes: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials.

Objective

Design

Data sources

Study selection

Data extraction

Results

Conclusion

Publications

Intensive glycaemic control for patients with type 2 diabetes: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials.

Similar Datasets

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