Calculating individualized glycaemic targets using an algorithm based on expert worldwide diabetologists: Implications in real‐ life clinical practice

Background: The aim of this study was to assess the clinical implications of calculating an individualized HbA1c target using a recently published algorithm in a real‐life clinical setting. Methods: General practitioners (GPs) from the Spanish Society of Family Medicine Diabetes Expert Group were invited to participate in the study. Each GP selected a random sample of patients with diabetes from his or her practice and submitted their demographic and clinical data for analysis. Individualized glycaemic targets were calculated according to the algorithm. Predictors of good glycaemic control were studied. The rate of patients attaining their individualized glycaemic target or the uniform target of HbA1c < 7.0% was calculated. Results: Forty GPs included 408 patients in the study. Of the 8 parameters included in the algorithm, “comorbidities,” “risk of hypoglycaemia from treatment,” and “diabetes duration” had the greatest impact on determining the individualized glycaemic target. Number of glucose‐ lowering agents and adherence were independently associated with glycaemic control. Overall, 60.5% of patients had good glycaemic control per individualized target, and 56.1% were well controlled per the uniform target of HbA1c < 7.0% (P = .20). However, 12.8% (23 of 246) of the patients with HbA1c ≥ 7.0% were adequately controlled per individualized target, and 2.6% (6 of 162) of the patients with HbA1c < 7.0% were uncontrolled since their individualized target was lower. Conclusions: In a real‐life clinical setting, applying individualized targets did not change the overall rate of patients with good glycaemic control yet led to reclassification of 7.1% (29 of 408) of the patients. More studies are needed to validate these results in different population

Imported Melioidosis, Israel, 2008

In 2008, melioidosis was diagnosed in an agricultural worker from Thailand in the southern Jordan Valley in Israel. He had newly diagnosed diabetes mellitus, fever, multiple abscesses, and osteomyelitis. Burkholderia pseudomallei was isolated from urine and blood. Four of 10 laboratory staff members exposed to the organism received chemoprophylaxis, 3 of whom had adverse events

Effect of Dapagliflozin on Cardiovascular Outcomes According to Baseline Kidney Function and Albuminuria Status in Patients With Type 2 Diabetes A Prespecified Secondary Analysis of a Randomized Clinical Trial

ImportanceSodium-glucose cotransporter 2 inhibitors, such as dapagliflozin, promote renal glucose excretion and reduce cardiovascular (CV) deaths and hospitalizations for heart failure (HHF) among patients with type 2 diabetes. The relative CV efficacy and safety of dapagliflozin according to baseline kidney function and albuminuria status are unknown.ObjectiveTo assess the CV efficacy and safety of dapagliflozin according to baseline estimated glomerular filtration rate (eGFR) and urinary albumin to creatinine ratio (UACR).Design, setting, and participantsThis secondary analysis of the randomized clinical trial Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58 compared dapagliflozin vs placebo in 17 160 patients with type 2 diabetes and a baseline creatinine clearance of 60 mL/min or higher. Patients were categorized according to prespecified subgroups of baseline eGFR (InterventionsDapagliflozin vs placebo.Main outcomes and measuresThe dual primary end points were major adverse cardiovascular events (myocardial infarction, stroke, and CV death) and the composite of CV death or HHF.ResultsAt baseline, 1265 patients (7.4%) had an eGFR below 60 mL/min/1.73 m2, and 5199 patients (30.9%) had albuminuria. Among patients having data for both eGFR and UACR, 10 958 patients (65.1%) had an eGFR equal to or higher than 60 mL/min/1.73 m2 and an UACR below 30 mg/g (mean [SD] age, 63.7 [6.7] years; 40.1% women), 5336 patients (31.7%) had either an eGFR below 60 mL/min/1.73 m2 or albuminuria (mean [SD] age, 64.1 [7.1] years; 32.6% women), and 548 patients (3.3%) had both (mean [SD] age, 66.8 [6.9] years; 30.5% women). In the placebo group, patients with more CKD markers had higher event rates at 4 years as assessed using the Kaplan-Meier approach for the composite of CV death or HHF (3.9% for 0 markers, 8.3% for 1 marker, and 17.4% for 2 markers) and major adverse cardiovascular events (7.5% for 0 markers, 11.6% for 1 marker, and 18.9% for 2 markers). Estimates for relative risk reductions for the composite of CV death or HHF and for major adverse cardiovascular events were generally consistent across subgroups (both P > .24 for interaction), although greater absolute risk reductions were observed with more markers of CKD. The absolute risk difference for the composite of CV death or HHF was greater for patients with more markers of CKD (0 markers, -0.5%; 1 marker, -1.0%; and 2 markers, -8.3%; P = .02 for interaction). The numbers of amputations, cases of diabetic ketoacidosis, fractures, and major hypoglycemic events were balanced or numerically lower with dapagliflozin compared with placebo for patients with an eGFR below 60 mL/min/1.73 m2 and an UACR of 30 mg/g or higher.Conclusions and relevanceThe effect of dapagliflozin on the relative risk for CV events was consistent across eGFR and UACR groups, with the greatest absolute benefit for the composite of CV death or HHF observed among patients with both reduced eGFR and albuminuria.Trial registrationClinicalTrials.gov Identifier: NCT01730534

The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58

OBJECTIVE Sodium-glucose cotransporter 2 inhibitors (SGLT2i) improve albuminuria in patients with high cardiorenal risk. We report albuminuria change in the Dapagliflozin Effect on Cardiovascular Events (DECLARE-TIMI 58) cardiovascular outcome trial, which included populations with lower cardiorenal risk. RESEARCH DESIGN AND METHODS DECLARE-TIMI 58 randomized 17,160 patients with type 2 diabetes, creatinine clearance >60 mL/min, and either atherosclerotic cardiovascular disease (CVD; 40.6%) or risk-factors for CVD (59.4%) to dapagliflozin or placebo. Urinary albumin-to-creatinine ratio (UACR) was tested at baseline, 6 months, 12 months, and yearly thereafter. The change in UACR over time was measured as a continuous and categorical variable (15 to = 30 to 300 mg/g) by treatment arm. The composite cardiorenal outcome was a >= 40% sustained decline in the estimated glomerular filtration rate (eGFR) to 15 to 300 mg/g. Measured as a continuous variable, UACR improved from baseline to 4.0 years with dapagliflozin, compared with placebo, across all UACR and eGFR categories (all P = 1 category improvement in UACR was more common in dapagliflozin versus placebo (hazard ratio 1.45 [95% CI 1.35-1.56], P = 30 mg/g (P < 0.0125, P-interaction = 0.033), and the renal-specific outcome was reduced for all UACR subgroups (P < 0.05, P-interaction = 0.480). CONCLUSIONS In DECLARE-TIMI 58, dapagliflozin demonstrated a favorable effect on UACR and renal-specific outcome across baseline UACR categories, including patients with normal albumin excretion. The results suggest a role for SGLT2i also in the primary prevention of diabetic kidney disease

Cardiorenal outcomes with dapagliflozin by baseline glucose-lowering agents: Post hoc analyses fromDECLARE-TIMI58

Aim To assess the associations between baseline glucose-lowering agents (GLAs) and cardiorenal outcomes with dapagliflozin versus placebo in the DECLARE-TIMI 58 study. Materials and methods DECLARE-TIMI 58 assessed the cardiorenal outcomes of dapagliflozin versus placebo in patients with type 2 diabetes. This post hoc analysis elaborates the efficacy and safety outcomes by baseline GLA for treatment effect and GLA-based treatment interaction. Results At baseline, 14 068 patients (82.0%) used metformin, 7322 (42.7%) sulphonylureas, 2888 (16.8%) dipeptidyl peptidase-4 inhibitors, 750 (4.4%) glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and 7013 (40.9%) insulin. Dapagliflozin reduced the composite of cardiovascular death (CVD) and hospitalization for heart failure (HHF) versus placebo regardless of baseline GLA, with greater benefit in the small group of patients with baseline use of GLP-1 RAs (HR [95% CI] 0.37 [0.18, 0.78] vs. 0.86 [0.75, 0.98] in GLP-1 RA users vs. non-users,P-interaction= .03). The overall HR for major adverse cardiovascular events (CVD, myocardial infarction or ischaemic stroke) was 0.93 (95% CI 0.84, 1.03) with dapagliflozin versus placebo, with no interaction by baseline GLA (P-interaction> .05). The renal-specific outcome was reduced with dapagliflozin versus placebo in the overall cohort (HR [95%CI] 0.53[0.43-0.66]), with no interaction by baseline GLA (P-interaction> .05). All of these outcomes were similar in those with versus those without baseline metformin use. Conclusions The effects of dapagliflozin on cardiorenal outcomes were generally consistent regardless of baseline GLA, with consistent benefits regardless of baseline metformin use. The potential clinical benefit of combining sodium-glucose co-transporter-2 inhibitors with GLP-1 RAs, given some evidence of cardiovascular risk reduction with both classes, should be explored further

Diabetes mellitus: in search of an improved classification and treatment algorithm

Our current clinical doctrine and practice is based upon a classification of diabetes which relies mainly on some clinical manifestations/criteria, rather than markers of the pathophysiological mechanisms of the disease. An improved classification based on such biological markers (i.e. of insulin resistance, beta cell dysfunction, autoimmunity) may assist in clinical decision and may offer the opportunity of an optimized therapeutic strategy. We address here some important questions that have not yet been clarified, e.g. which markers/indicators best define the main pathogenic mechanisms of the disease in a patient with diabetes and what threshold values are relevant for this purpose

New forms of insulin and insulin therapies for the treatment of type 2 diabetes

Insulin is a common treatment option for many patients with type 2 diabetes, and is generally used late in the natural history of the disease. Its injectable delivery mode, propensity for weight gain and hypoglycaemia, and the paucity of trials assessing the risk-to-safety ratio of early insulin use are major shortcomings associated with its use in patients with type 2 diabetes. Development of new insulins-such as insulin analogues, including long-acting and short-acting insulins-now provide alternative treatment options to human insulin. These novel insulin formulations and innovative insulin delivery methods, such as oral or inhaled insulin, have been developed with the aim to reduce insulin-associated hypoglycaemia, lower intraindividual pharmacokinetic and pharmacodynamic variability, and improve imitation of physiological insulin release. Availability of newer glucose-lowering drugs (such as glucagon-like peptide-1 receptor agonists, dipeptidyl peptidase-4 inhibitors, and sodium-glucose co-transporter-2 inhibitors) also offers the opportunity for combination treatment; the results of the first trials in this area of research suggest that such treatment might lead to use of reduced insulin doses, less weight gain, and fewer hypoglycaemic episodes than insulin treatment alone. These and future developments will hopefully offer better opportunities for individualisation of insulin treatment for patients with type 2 diabetes. Copyright © 2015 Elsevier Ltd. All rights reserved

Digital Diabetes Care System Observations from a Pilot Evaluation Study in Vietnam

Digital technologies are gaining an important role in the management of patients with diabetes. We assessed clinical outcomes and user satisfaction of incorporating a digital diabetes care system in diabetes clinics of a developing country. The system integrated a wireless blood glucose monitor that communicates data to any smartphone utilizing a patented acoustic data transfer method, a mobile-app, and cloud-based software that stores, analyzes, and presents data. Five hospital endocrinology clinics in Vietnam sequentially recruited all patients willing to join the study, providing they had a smartphone and access to internet connectivity. Face-to-face visits were conducted at baseline and at 12 weeks, with monthly digital visits scheduled in the interim and additional digital visits performed as needed. HbA1c levels were measured at baseline and at 12 weeks (&plusmn;20 days). The study included 300 patients of whom 279 completed the evaluation. Average glucose levels declined from 170.4 &plusmn; 64.6 mg/dL in the first 2 weeks to 150.8 &plusmn; 53.2 mg/dL in the last 2 weeks (n = 221; p &lt; 0.001). HbA1c levels at baseline and 12 weeks declined from 8.3% &plusmn; 1.9% to 7.6% &plusmn; 1.3% (n = 126; p &lt; 0.001). The digital solution was broadly accepted by both patients and healthcare professionals and improved glycemic outcomes. The durability, scalability, and cost-effectiveness of this approach merits further study

The addition of e (Empowerment and Economics) to the ABCD algorithm in diabetes care

The ABCD (Age, Body weight, Complications, Duration of disease) algorithm was proposed as a simple and practical tool to manage patients with type 2 diabetes. Diabetes treatment, as for all chronic diseases, relies on patients' ability to cope with daily problems concerning the management of their disease in accordance with medical recommendations. Thus, it is important that patients learn to manage and cope with their disease and gain greater control over actions and decisions affecting their health. Healthcare professionals should aim to encourage and increase patients' perception about their ability to take informed decisions about disease management and to improve patient self-esteem and feeling of self-efficacy to become agents of their own health. E for Empowerment is therefore an additional factor to take into account in the management of patients with type 2 diabetes. E stands also for Economics to be considered in diabetes care. Attention should be paid to public health policies as well as to the physician faced with the dilemma of delivering the best possible care within the problem of limited resources. The financial impact of the new treatment modalities for diabetes represents an issue that needs to be addressed at multiple strata both globally and nationally. Copyright © 2015 Elsevier Inc. All rights reserved