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Renal Failure Dec 2023The safety of sodium-glucose co-transporter 2 (SGLT2) inhibitors in elderly patients with diabetic kidney disease (DKD) is still controversial. This study aimed to... (Meta-Analysis)
Meta-Analysis Review
Comparative safety of sodium-glucose co-transporter 2 inhibitors in elderly patients with type 2 diabetes mellitus and diabetic kidney disease: a systematic review and meta-analysis.
The safety of sodium-glucose co-transporter 2 (SGLT2) inhibitors in elderly patients with diabetic kidney disease (DKD) is still controversial. This study aimed to analyze the safety of SGLT2 inhibitors in elderly patients with type 2 diabetes mellitus (T2DM) and DKD. We systematically searched PubMed, Embase, Web of Science, and the Cochrane Library from inception to March 2023. Randomized controlled trials (RCTs) were included. Data including patient characteristics and interesting outcomes were extracted, and the dichotomous data and continuous variables were evaluated using risk ratio (RR) with 95% confidence intervals (CIs) and mean difference (MD) with 95% CIs, respectively. A total of 14 RCTs with 59874 participants were finally included. There were 38,252 males (63.9%) and 21,622 females (36.1%). The patients' mean age was > 64.6 years. SGLT2 inhibitors could delay the further decline of estimated glomerular filtration rate (eGFR) when eGFR ≥ 60 ml/min/1.73m (MD: 2.36; 95%CI [1.15-3.57]). SGLT2 inhibitors in elderly patients with eGFR < 60 ml/min/1.73m (RR: 0.86; 95%CI [0.67-1.11]) may have a relatively increased risk of acute kidney injury compared to eGFR ≥ 60 ml/min/1.73m. SGLT2 inhibitors increased the incidence of genital mycotic infections (RR: 3.47; 95%CI [2.97-4.04]) and diabetic ketoacidosis (RR: 2.25; 95%CI [1.57-3.24]). Except for genital mycotic infections and diabetic ketoacidosis, other adverse reactions were few, indicating that SGLT2 inhibitors are relatively safe for elderly patients with T2DM and DKD. Safety and renoprotection may be diminished when SGLT2 inhibitors are used in elderly patients with eGFR < 60 ml/min/1.73m.
Topics: Male; Female; Humans; Aged; Middle Aged; Sodium-Glucose Transporter 2 Inhibitors; Diabetic Nephropathies; Diabetic Ketoacidosis; Diabetes Mellitus, Type 2; Symporters; Glucose; Sodium; Hypoglycemic Agents
PubMed: 37246403
DOI: 10.1080/0886022X.2023.2217287 -
Diabetes Care Apr 2020Identifying patients at high risk of diabetic kidney disease (DKD) helps improve clinical outcome. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Identifying patients at high risk of diabetic kidney disease (DKD) helps improve clinical outcome.
PURPOSE
To establish a model for predicting DKD.
DATA SOURCES
The derivation cohort was from a meta-analysis. The validation cohort was from a Chinese cohort.
STUDY SELECTION
Cohort studies that reported risk factors of DKD with their corresponding risk ratios (RRs) in patients with type 2 diabetes were selected. All patients had estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m and urinary albumin-to-creatinine ratio (UACR) <30 mg/g at baseline.
DATA EXTRACTION
Risk factors and their corresponding RRs were extracted. Only risk factors with statistical significance were included in our DKD risk prediction model.
DATA SYNTHESIS
Twenty cohorts including 41,271 patients with type 2 diabetes were included in our meta-analysis. Age, BMI, smoking, diabetic retinopathy, hemoglobin A, systolic blood pressure, HDL cholesterol, triglycerides, UACR, and eGFR were statistically significant. All these risk factors were included in the model except eGFR because of the significant heterogeneity among studies. All risk factors were scored according to their weightings, and the highest score was 37.0. The model was validated in an external cohort with a median follow-up of 2.9 years. A cutoff value of 16 was selected with a sensitivity of 0.847 and a specificity of 0.677.
LIMITATIONS
There was huge heterogeneity among studies involving eGFR. More evidence is needed to power it as a risk factor of DKD.
CONCLUSIONS
The DKD risk prediction model consisting of nine risk factors established in this study is a simple tool for detecting patients at high risk of DKD.
Topics: Adult; Age of Onset; Aged; Blood Pressure; Cohort Studies; Diabetes Mellitus, Type 2; Diabetic Nephropathies; Diabetic Retinopathy; Female; Glomerular Filtration Rate; Glycated Hemoglobin; Humans; Kidney Function Tests; Male; Middle Aged; Models, Statistical; Prognosis; Risk Factors; Time Factors
PubMed: 32198286
DOI: 10.2337/dc19-1897 -
JAMA Network Open Mar 2023Type 2 diabetes (T2D) is increasing globally. Diabetic retinopathy (DR) is a leading cause of blindness in adults with T2D; however, the global burden of DR in pediatric... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Type 2 diabetes (T2D) is increasing globally. Diabetic retinopathy (DR) is a leading cause of blindness in adults with T2D; however, the global burden of DR in pediatric T2D is unknown. This knowledge can inform retinopathy screening and treatments to preserve vision in this population.
OBJECTIVE
To estimate the global prevalence of DR in pediatric T2D.
DATA SOURCES
MEDLINE, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Library, the Web of Science, and the gray literature (ie, literature containing information that is not available through traditional publishing and distribution channels) were searched for relevant records from the date of database inception to April 4, 2021, with updated searches conducted on May 17, 2022. Searches were limited to human studies. No language restrictions were applied. Search terms included diabetic retinopathy; diabetes mellitus, type 2; prevalence studies; and child, adolescent, teenage, youth, and pediatric.
STUDY SELECTION
Three teams, each with 2 reviewers, independently screened for observational studies with 10 or more participants that reported the prevalence of DR. Among 1989 screened articles, 27 studies met the inclusion criteria for the pooled analysis.
DATA EXTRACTION AND SYNTHESIS
This systematic review and meta-analysis followed the Meta-analysis of Observational Studies in Epidemiology (MOOSE) and the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guidelines for systematic reviews and meta-analyses. Two independent reviewers performed the risk of bias and level of evidence analyses. The results were pooled using a random-effects model, and heterogeneity was reported using χ2 and I2 statistics.
MAIN OUTCOMES AND MEASURES
The main outcome was the estimated pooled global prevalence of DR in pediatric T2D. Other outcomes included DR severity and current DR assessment methods. The association of diabetes duration, sex, race, age, and obesity with DR prevalence was also assessed.
RESULTS
Among the 27 studies included in the pooled analysis (5924 unique patients; age range at T2D diagnosis, 6.5-21.0 years), the global prevalence of DR in pediatric T2D was 6.99% (95% CI, 3.75%-11.00%; I2 = 95%; 615 patients). Fundoscopy was less sensitive than 7-field stereoscopic fundus photography in detecting retinopathy (0.47% [95% CI, 0%-3.30%; I2 = 0%] vs 13.55% [95% CI, 5.43%-24.29%; I2 = 92%]). The prevalence of DR increased over time and was 1.11% (95% CI, 0.04%-3.06%; I2 = 5%) at less than 2.5 years after T2D diagnosis, 9.04% (95% CI, 2.24%-19.55%; I2 = 88%) at 2.5 to 5.0 years after T2D diagnosis, and 28.14% (95% CI, 12.84%-46.45%; I2 = 96%) at more than 5 years after T2D diagnosis. The prevalence of DR increased with age, and no differences were noted based on sex, race, or obesity. Heterogeneity was high among studies.
CONCLUSIONS AND RELEVANCE
In this study, DR prevalence in pediatric T2D increased significantly at more than 5 years after diagnosis. These findings suggest that retinal microvasculature is an early target of T2D in children and adolescents, and annual screening with fundus photography beginning at diagnosis offers the best assessment method for early detection of DR in pediatric patients.
Topics: Adult; Adolescent; Humans; Child; Child, Preschool; Diabetic Retinopathy; Diabetes Mellitus, Type 2; Prevalence; Retina; Obesity; Observational Studies as Topic
PubMed: 36930156
DOI: 10.1001/jamanetworkopen.2023.1887 -
Endocrinology, Diabetes & Metabolism Jan 2021The aim of this systematic review was to identify the best footwear and insole design features for offloading the plantar surface of the foot to prevent foot ulceration... (Meta-Analysis)
Meta-Analysis Review
The aim of this systematic review was to identify the best footwear and insole design features for offloading the plantar surface of the foot to prevent foot ulceration in people with diabetic peripheral neuropathy. We searched multiple databases for published and unpublished studies reporting offloading footwear and insoles for people with diabetic neuropathy and nonulcerated feet. Primary outcome was foot ulcer incidence; other outcome measures considered were any standardized kinetic or kinematic measure indicating loading or offloading the plantar foot. Fifty-four studies, including randomized controlled studies, cohort studies, case-series, and a case-controlled and cross-sectional study were included. Three meta-analyses were conducted and random-effects modelling found peak plantar pressure reduction of arch profile (37 kPa (MD, -37.5; 95% CI, -72.29 to -3.61; < .03), metatarsal addition (35.96 kPa (MD, -35.96; 95% CI, -57.33 to -14.60; < .001) and pressure informed design 75.4 kPa (MD, -75.4 kPa; 95% CI, -127.4 to -23.44 kPa; < .004).The remaining data were presented in a narrative form due to heterogeneity. This review highlights the difficulty in differentiating the effect of different insole and footwear features in offloading the neuropathic diabetic foot. However, arch profiles, metatarsal additions and apertures are effective in reducing plantar pressure. The use of pressure analysis to enhance the effectiveness of the design of footwear and insoles, particularly through modification, is recommended.
Topics: Diabetic Foot; Diabetic Nephropathies; Equipment Design; Foot Orthoses; Humans; Shoes; Treatment Outcome
PubMed: 33532602
DOI: 10.1002/edm2.132 -
Diabetes/metabolism Research and Reviews Jan 2019Type 2 diabetes (T2D) is a risk factor for cataract development. With T2D prevalence increasing, the burden of cataract-associated vision loss will also increase. We...
Type 2 diabetes (T2D) is a risk factor for cataract development. With T2D prevalence increasing, the burden of cataract-associated vision loss will also increase. We aimed to characterise cataract diabetes-specific risk factors to assist prevention and management strategies. As part of a systematic review, two investigators independently searched online electronic databases according to a predetermined protocol for relevant published data to end-March 2018. Studies were included if they were longitudinal with ≥100 participants, diabetes was defined, a description of cataract assessment was provided, data were from humans, and the reports were in English. Study quality was assessed using the Newcastle Ottawa Scale and GRADE. Of 5255 publications identified, 19 from 13 study populations were included. The overall risk of bias was low. There was between-study variability. Age and glycaemic control were consistently associated with cataract development in T2D, but blood pressure, diabetes duration, sex, and aspirin use were not. Serum lipids and smoking remain possible risk factors, but available data are inconclusive. Glycaemia is the only consistent modifiable risk factor amongst a range of candidate variables. Due to the lack of consistency of the available evidence, and since mortality associated with T2D is declining with the likelihood of increased cataract-associated vision loss, additional well-conducted longitudinal studies are needed to identify modifiable risk factors that could prevent or delay cataract formation.
Topics: Age Factors; Blood Glucose; Cataract; Diabetes Complications; Diabetes Mellitus, Type 2; Humans; Risk Factors
PubMed: 30209868
DOI: 10.1002/dmrr.3073 -
Diabetes, Obesity & Metabolism Aug 2019Traditional Chinese medicine (TCM) has recorded knowledge of diabetes for over 2000 years. Because a considerable number of TCM studies exhibit design defects, such as... (Meta-Analysis)
Meta-Analysis
Traditional Chinese medicine (TCM) has recorded knowledge of diabetes for over 2000 years. Because a considerable number of TCM studies exhibit design defects, such as limited intervention duration, small sample sizes and inconsistent efficacy evaluations, the role of TCM in the treatment of diabetes cannot be fully elucidated. In this review, we evaluate randomized controlled trials of prediabetes, diabetes and diabetic complications published in the past decade. We found that TCM could significantly improve glucose control and clinical indices in patients with diabetes and effectively delay the progression of diabetes. We also summarize potential pharmacological mechanisms underlying the efficacy of TCM medication/herbs and their active ingredients for treating diabetes. More rigorously designed experiments and long-term evaluation of TCM for diabetes will allow for more effective diabetes management.
Topics: Adult; Diabetes Complications; Diabetes Mellitus, Type 2; Drugs, Chinese Herbal; Female; Humans; Male; Medicine, Chinese Traditional; Phytotherapy; Prediabetic State; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31050124
DOI: 10.1111/dom.13760 -
The Lancet. Diabetes & Endocrinology Feb 2019Diabetic retinopathy is a leading cause of vision impairment and blindness. We systematically reviewed studies published from Jan 1, 1980, to Jan 7, 2018, assessed the...
Diabetic retinopathy is a leading cause of vision impairment and blindness. We systematically reviewed studies published from Jan 1, 1980, to Jan 7, 2018, assessed the methodological quality, and described variations in incidence of diabetic retinopathy by region with a focus on population-based studies that were conducted after 2000 (n=8, including two unpublished studies). Of these eight studies, five were from Asia, and one each from the North America, Caribbean, and sub-Saharan Africa. The annual incidence of diabetic retinopathy ranged from 2·2% to 12·7% and progression from 3·4% to 12·3%. Progression to proliferative diabetic retinopathy was higher in individuals with mild disease compared with those with no disease at baseline. Our Review suggests that more high-quality population-based studies capturing data on the incidence and progression of diabetic retinopathy with stratification by age and sex are needed to consolidate the evidence base. Our data is useful for conceptualisation and development of major public health strategies such as screening programmes for diabetic retinopathy.
Topics: Africa; Asia; Australia; Caribbean Region; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Retinopathy; Disease Progression; Europe; Humans; Incidence; North America
PubMed: 30005958
DOI: 10.1016/S2213-8587(18)30128-1 -
Diabetes, Obesity & Metabolism Sep 2020To assess the effects of sodium-glucoseco-transporter-2 (SGLT2) inhibitors on diabetic ketoacidosis (DKA) in patients with type 2 diabetes. (Meta-Analysis)
Meta-Analysis
Sodium-glucose co-transporter-2 inhibitors and the risk of diabetic ketoacidosis in patients with type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.
AIM
To assess the effects of sodium-glucoseco-transporter-2 (SGLT2) inhibitors on diabetic ketoacidosis (DKA) in patients with type 2 diabetes.
MATERIALS AND METHODS
We searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov from inception to 13 June 2019 for randomized controlled trials (RCTs) that compared SGLT2 inhibitors with control in patients with type 2 diabetes. Paired reviewers independently screened citations, assessed the risk of bias and extracted data. Peto's method was used as the primary approach to pool the effect of SGLT2 inhibitors on DKA. Sensitivity analyses with the alternative effect measure (risk ratio) or pooling method (Mantel-Haenszel), the use of continuity correction of 0.5 for zero-event trials or a generalized linear mixed model were conducted. Six preplanned subgroup analyses were performed to explore heterogeneity. The grading of recommendations assessment, development and evaluation (GRADE) approach was used to rate the quality of evidence.
RESULTS
A total of 39 RCTs were included, involving 60 580 patients and 85 DKA events. SGLT2 inhibitors were statistically associated with an increased risk of DKA versus control (SGLT2 inhibitors: 62/34 961 [0.18%] vs. control: 23/25 211 [0.09%], Peto odds ratio [OR] 2.13, 95% confidence interval [CI] 1.38 to 3.27, I = 8%; RD 1.7 more events, 95% CI 0.6 more to 3.4 more events per 1000 over 5 years; high-quality evidence). Sensitivity analyses showed similar results. The subgroup analyses by mean age (interaction P = 0 .02) and length of follow-up (interaction P = 0 .03) showed a larger relative effect among older patients (aged ≥60 years) and those with longer use of SGLT2 inhibitors (>52 weeks).
CONCLUSIONS
High-quality evidence suggests that SGLT2 inhibitors may increase the risk of DKA in patients with type 2 diabetes. The apparent differences in treatment effects among patients of a different age or follow-up were probable, suggesting the advisability of caution in patients with long-term use of SGLT2 inhibitors or in older patients.
Topics: Aged; Diabetes Mellitus, Type 2; Diabetic Ketoacidosis; Glucose; Humans; Hypoglycemic Agents; Middle Aged; Randomized Controlled Trials as Topic; Sodium; Sodium-Glucose Transporter 2 Inhibitors; Symporters
PubMed: 32364674
DOI: 10.1111/dom.14075 -
Diabetes/metabolism Research and Reviews Mar 2020Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of...
BACKGROUND
Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers.
METHODS
We updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient-reported measures, and cost-effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non-controlled studies were summarised on a narrative basis.
RESULTS
We identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta-analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non-controlled studies. Five meta-analyses and 12 RCTs provided high-quality evidence for non-removable knee-high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non-removable knee-high walkers were shown to be equally effective. Moderate-quality evidence exists for removable knee-high and ankle-high offloading devices being equally effective in healing, but knee-high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low-quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non-plantar ulcers, and neuropathic ulcers with infection or ischemia.
CONCLUSION
Strong evidence supports the use of non-removable knee-high offloading devices (either TCC or non-removable walker) as the first-choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee-high or ankle-high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high-quality controlled studies are needed in these areas.
Topics: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Foot; Disease Management; Evidence-Based Medicine; Humans; Practice Guidelines as Topic; Practice Patterns, Physicians'; Prognosis
PubMed: 32176438
DOI: 10.1002/dmrr.3275 -
Diabetes/metabolism Research and Reviews Mar 2020Prevention of foot ulcers in patients with diabetes is important to help reduce the substantial burden on both patient and health resources. A comprehensive analysis of...
Prevention of foot ulcers in patients with diabetes is important to help reduce the substantial burden on both patient and health resources. A comprehensive analysis of reported interventions is needed to better inform healthcare professionals about effective prevention. The aim of this systematic review is to investigate the effectiveness of interventions to help prevent both first and recurrent foot ulcers in persons with diabetes who are at risk for this complication. We searched the available medical scientific literature in PubMed, EMBASE, CINAHL, and the Cochrane databases for original research studies on preventative interventions. We screened trial registries for additional studies not found in our search and unpublished trials. Two independent reviewers assessed data from controlled studies for methodological quality, and extracted and presented this in evidence and risk of bias tables. From the 13,490 records screened, 35 controlled studies and 46 non-controlled studies were included. Few controlled studies, which were of generally low to moderate quality, were identified on the prevention of a first foot ulcer. For the prevention of recurrent plantar foot ulcers, there is benefit for the use of daily foot skin temperature measurements, and for therapeutic footwear with demonstrated plantar pressure relief, provided it is consistently worn by the patient. For prevention of ulcer recurrence, there is some evidence for providing integrated foot care, and no evidence for a single session of education.Surgical interventions have been shown effective in selected patients, but the evidence base is small. Foot-related exercises do not appear to prevent a first foot ulcer. A small increase in the level of weight-bearing daily activities does not seem to increase the risk for foot ulceration. The evidence base to support the use of specific self-management and footwear interventions for the prevention of recurrent plantar foot ulcers is quite strong. The evidence is weak for the use of other, sometimes widely applied, interventions, and is practically non-existent for the prevention of a first foot ulcer and non-plantar foot ulcer.
Topics: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Foot; Disease Management; Humans; Patient Compliance; Patient Education as Topic; Practice Guidelines as Topic; Practice Patterns, Physicians'
PubMed: 31957213
DOI: 10.1002/dmrr.3270