Adult Type 2 Diabetes Mellitus Patients Research Articles

The burden of severe hypoglycemia in type 2 diabetes

Aims: More than 29 million people in the US have type 2 diabetes mellitus (T2DM), a chronic metabolic disorder characterized by a progressive deterioration of glucose control, which eventually requires insulin. Abnormally low levels of blood glucose, a feared side-effect of insulin treatment, may cause severe hypoglycemia (SHO), leading to emergency department (ED) admission, hospitalization, and long-term complications; these, in turn, drive up the costs of T2DM. This study’s objective was to estimate the prevalence and costs of SHO-related hospitalizations and their additional longer-term impacts on patients with T2DM using insulin.Methods: Using Truven MarketScan claims, we identified adult T2DM patients using basal and basal-bolus insulin regimens who were hospitalized for SHO (inpatient SHO patients) during 2010–2015. Two comparison groups were defined: those with outpatient SHO-related encounters only, including ED visits without hospitalization (outpatient SHO patients), and those with no SHO- or acute hyperglycemia-related events (comparison patients). Lengths of stay and SHO-related hospitalization costs were estimated, and propensity score and inverse probability weighting methods were used to adjust for baseline differences across the groups to evaluate longer-term impacts.Results: We identified 66,179 patients using basal and 81,876 patients using basal-bolus insulin, of which ∼1.1% (basal) to 3.2% (basal-bolus) experienced at least one SHO-related hospitalization. Among those who experienced SHO (i.e. those in the inpatient and outpatient SHO groups), 27% (basal) and 40% (basal-bolus) experienced at least one SHO-related hospitalization. One-third of basal and about one-quarter of basal-bolus patients were admitted directly to the hospital; the remainder were first assessed or treated in the ED. Inpatient SHO patients using basal insulin stayed in the hospital, including time in the ED, for 2.8 days and incurred $6896 in costs; patients using basal-bolus insulin stayed in the hospital for 2.6 days and incurred costs of $5802. Forty-to-fifty percent of inpatient SHO patients were hospitalized again for SHO. Inpatient SHO patients using basal insulin incurred significantly higher monthly costs after their initial SHO-related hospitalization than patients in the other two groups ($2935 vs $1819 and $1638), corresponding to 61% and 79% higher monthly costs; patients using basal-bolus insulin also incurred significantly higher monthly costs than patients in the other groups ($3606 vs $2731 and $2607), corresponding to 32% and 38% higher monthly costs.Limitations: These analyses excluded patients who did not seek ED or hospital care when faced with SHO; events may have been miscoded; and we were not able to account for clinical characteristics associated with SHO, such as insulin dose and duration of diabetes, or unmeasured confounders.Conclusions: The burden associated with SHO is not negligible. Nearly one in three patients using only basal insulin and one in four patients using basal-bolus regimens who experienced SHO were hospitalized at least once due to SHO. Not only did those patients incur the costs of their SHO hospitalization, but they also incurred at least $1,116 (62%) and $875 (70%) more per month than outpatient SHO or comparison patients. Reducing SHO events can help decrease the burden associated with SHO among patients with T2DM.

The burden of severe hypoglycemia in type 1 diabetes

Aims: Approximately 1.25 million people in the US have type 1 diabetes mellitus (T1DM), a chronic metabolic disease that develops from the body’s inability to produce insulin, and requires life-long insulin therapy. Poor insulin adherence may cause severe hypoglycemia (SHO), leading to hospitalization and long-term complications; these, in turn, drive up costs of SHO and T1DM overall. This study’s objective was to estimate the prevalence and costs of SHO-related hospitalizations and their additional longer-term impacts on patients with T1DM using basal-bolus insulin.Methods: Using Truven MarketScan claims, we identified adult T1DM patients using basal-bolus insulin regimens who were hospitalized for SHO (inpatient SHO patients) during 2010–2015. Two comparison groups were defined: those with outpatient SHO-related encounters only, including emergency department (ED) visits without hospitalization (outpatient SHO patients), and those with no SHO- or acute hyperglycemia-related events (comparison patients). Lengths of stay and SHO-related hospitalization costs were estimated and propensity score and inverse probability weighting methods were used to adjust for baseline differences across the groups to evaluate longer-term impacts.Results: We identified 8,734 patients, of which 4.2% experienced at least one SHO-related hospitalization. Among those who experienced SHO (i.e. of those in the inpatient and outpatient SHO groups), 31% experienced at least one SHO-related hospitalization, while 9% were treated in the ED without subsequent hospitalization. Approximately 79% of patients were admitted directly to the hospital; the remainder were first assessed or treated in the ED. The inpatient SHO patients stayed in the hospital, including time in the ED, for 1.7 days and incurred $3551 in costs. About one-third of patients were hospitalized again for SHO. Inpatient SHO patients incurred significantly higher monthly costs after their initial SHO-related hospitalization than patients in the two other groups ($2084 vs $1313 and $1372), corresponding to 59% or 52% higher monthly costs for inpatient SHO patients.Limitations: These analyses excluded patients who did not seek ED or hospital care when faced with SHO; events may have been miscoded; and we were not able to account for clinical characteristics associated with SHO, such as insulin dose and duration of diabetes, or unmeasured confounders.Conclusions: The burden associated with SHO is not negligible. About 4% of T1DM patients using basal-bolus insulin regimens are hospitalized at least once due to SHO. Not only did those patients incur the costs of their SHO hospitalization, but they also incur red at least $712 (52%) more in costs per month after their hospitalization than outpatient SHO or comparison patients. Reducing SHO events can help decrease the burden associated with SHO among patients with T1DM.

Circulating Endothelial Progenitor Cells in Type 1 Diabetic Patients: Relation with Patients' Age and Disease Duration.

Circulating endothelial progenitor cells (cEPCs) have been reported to be dysfunctional in diabetes mellitus (DM) patients, accounting for the vascular damage and the ensuing high risk for cardiovascular disease (CVD) characteristic of this disease. The aim of the present study was to evaluate the number of circulating cEPCs in type 1 DM (T1DM) patients, without clinical vascular damage, of different ages and with different disease duration. An observational, clinical-based prospective study was performed on T1DM patients enrolled in two clinical centers. cEPCs were determined by flow cytometry, determining the number of CD34/CD133/VEGFR2-positive cells within peripheral blood mononuclear cells (PBMCs). The number of cEPCs was lower in adult T1DM patients, whilst higher in childhood/young patients, compared to controls of the same age range. When patients were grouped into two age groups (≥ or <20 years) (and categorized on the basis of the duration of the disease), the number of cEPCs in young (<20 years) patients was higher compared with older subjects, regardless of disease duration. A subset of patients with very high cEPCs was identified in the <20 years group. There is an association between the number of cEPCs and patients' age: childhood/young T1DM patients have significantly higher levels of cEPCs, respect to adult T1DM patients. Such difference is maintained also when the disease lasts for more than 10 years. The very high levels of cEPCs, identified in a subset of childhood/young patients, might protect vessels against endothelial dysfunction and damage. Such protection would be less operative in older subjects, endowed with lower cEPC numbers, in which complications are known to develop more easily.

Development and Validation of a Questionnaire Evaluating Impaired Hypoglycemia Awareness among Adult Filipino Patients with Type 2 Diabetes Mellitus.

IntroductionHazards of hypoglycemia include accidents, cardiovascular events, neurologic damage, and impaired hypoglycemia awareness (IHA) which presents as inability to perceive and respond to hypoglycemic warning symptoms.ObjectiveThis study aimed to develop the first questionnaire evaluating IHA adapted from Clarke Hypoglycemia Index (CHI) and validated among adult Filipino patients with Type 2 Diabetes Mellitus (T2DM).MethodologyA questionnaire development study was conducted involving CHI linguistic translation, its modification through literature review and focus group discussions, panel synthesis, and content validity. A cross-sectional analytic study followed by administration of the questionnaire to 117 adult Filipinos with T2DM, advanced age, long-standing T2DM, insulin or sulfonylurea, polypharmacy, comorbidities and/or prior hypoglycemia. There were 9 participants in pilot testing, 69 in criterion validity against continuous glucose monitoring (CGM), and 108 in construct validity.ResultsIHA domains in the concept map included Elusive Euglycemia Model, Developmental Model, and Cognitive Model. The Filipino-CHI formulated had 8 questions with content validity scores ranging from 87.5-93.75%. Owing to brevity, its internal consistency Cronbach’s alpha was 0.45. Criterion validity against CGM yielded 21 patients with biochemical hypoglycemic events, of which 2 had clinical hypoglycemic events and 19 were positive monitor-identified IHA. A questionnaire IHA cutoff score of ≥4 had sensitivity of 89.47%, and area under the curve of 0.55.ConclusionAn 8-item questionnaire evaluating IHA among adult Filipino T2DM patients was developed and validated.

Improvement of Glycosylated Hemoglobin in Patients with Type 2 Diabetes Mellitus under Insulin Treatment by Reimbursement for Self-Monitoring of Blood Glucose.

BackgroundIn Korea, the costs associated with self-monitoring of blood glucose (SMBG) for patients with type 2 diabetes mellitus (T2DM) under insulin treatment have been reimbursed since November 2015. We investigated whether this new reimbursement program for SMBG has improved the glycemic control in the beneficiaries of this policy.MethodsAmong all adult T2DM patients with ≥3 months of reimbursement (n=854), subjects without any changes in anti-hyperglycemic agents during the study period were selected. The improvement of glycosylated hemoglobin (HbA1c) was defined as an absolute reduction in HbA1c ≥0.6% or an HbA1c level at follow-up <7%.ResultsHbA1c levels significantly decreased from 8.5%±1.3% to 8.2%±1.2% during the follow-up (P<0.001) in all the study subjects (n=409). Among them, 35.5% (n=145) showed a significant improvement in HbA1c. Subjects covered under the Medical Aid system showed a higher prevalence of improvement in HbA1c than those with medical insurance (52.2% vs. 33.3%, respectively, P=0.012). In the improvement group, the baseline HbA1c (P<0.001), fasting C-peptide (P=0.016), and daily dose of insulin/body weight (P=0.024) showed significant negative correlations with the degree of HbA1c change. Multivariate analysis showed that subjects in the Medical Aid system were about 2.5-fold more likely to improve in HbA1c compared to those with medical insurance (odds ratio, 2.459; 95% confidence interval, 1.138 to 5.314; P=0.022).ConclusionThe reimbursement for SMBG resulted in a significant improvement in HbA1c in T2DM subjects using insulin, which was more prominent in subjects with poor glucose control at baseline or covered under the Medical Aid system.

Cortical Bone Size Deficit in Adult Patients With Type 1 Diabetes Mellitus.

The increased fracture risk associated with type 1 diabetes mellitus (T1DM) remains unexplained by traditional risk factors such as low areal bone mineral density (aBMD). Nonetheless, few data exist on other determinants of bone strength in T1DM, including volumetric bone mineral density (vBMD) and bone geometry. We compared areal and volumetric bone parameters and cortical bone geometry in adult T1DM patients and sex- and age-matched controls. Cross-sectional study including 64 adult T1DM patients (38 men; mean age, 41.1 ± 8.1 years) and 63 sex- and age-matched controls. Areal bone parameters using dual-energy X-ray absorptiometry; volumetric bone parameters and cortical bone geometry using peripheral quantitative computed tomography. T1DM was associated with lower aBMD at the total body, femoral neck, and total hip; lower trabecular vBMD at the distal radius; and higher cortical but lower total vBMD at the radial shaft. In addition, subjects with T1DM had a similar periosteal but larger endosteal circumference, smaller cortical thickness, and lower cortical over total bone area ratio. Differences in bone parameters could not be explained by differences in bone turnover markers or body composition, but cortical area was inversely associated with glycemic variability and long-term glycemic control. Besides decreased aBMD and trabecular vBMD, adult T1DM patients present with a cortical bone size deficit, which may contribute to their increased fracture risk. This deficit is mainly situated at the endosteal envelope, suggesting imbalanced remodeling rather than compromised modeling processes as the underlying mechanism.

Prevalence of chronic kidney disease stages 3-5 among patients with type 2 diabetes mellitus in Bangladesh

Background and objectives: Diabetes mellitus is one of the most common causes of chronic kidney disease (CKD). The prevalence of CKD in type 2 diabetes mellitus (T2DM) in Bangladesh is not well described. The present study aimed to find out the prevalence of CKD stages 3-5 and its risk factors among selected Bangladeshi T2DM patients.Methods: This cross-sectional study was conducted in BIRDEM (Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders) General Hospital, Dhaka, Bangladesh from July to December 2015. Diagnosed adult T2DM patients were consecutively and purposively included in this study. Pregnant women, patients with diagnosed kidney disease due to non-diabetic etiology, acute kidney injury (AKI), AKI on CKD and patients on renal replacement therapy were excluded. Age, gender, body mass index (BMI) and laboratory parameters were recorded systematically in a predesigned data sheet. Diagnosis of CKD and its stages were determined according to Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines 2012 and estimated glomerular filtration rate (eGFR). Estimated GFR was calculated by using Modification of Diet in Renal Disease (MDRD), Cockcroft-Gault (CG) and Chronic Kidney Disease Epidemiology (CKDEPI) creatinine based formula.Results: A total of 400 patients with T2DM of various durations were enrolled in the study. Out of 400 patients, 254 (63.5%), 259 (64.75%) and 218 (54.5%) cases had CKD stages 3-5 according to MDRD, C-G and CKD-EPI equations respectively. CKD was significantly more common in females (p&lt;0.001) and in cases with long duration of diabetes (?5 years; p=0.007). CKD stages 3-5 were significantly associated with hypertension (?2=5.2125, p =0.02) and good control of diabetes (HbA1c &lt;7%) as evidenced by higher proportion of CKD in them (73.3%) compared to those with poor glycemic control (52.1%).Conclusions: More than half of T2DM patients had CKD stages 3-5. Female gender, duration of diabetes and hypertension were significant risk factors and should be emphasized for the prevention of CKD in T2DM. Glycemic control may not reduce CKD in diabetes.IMC J Med Sci 2017; 11(1): 19-24

Retrospective Study on the Impact of Adherence in Achieving Glycemic Goals in Type 2 Diabetes Mellitus Patients Receiving Canagliflozin.

Adherence is poor among patients taking antihyperglycemic agents (AHAs) for type 2 diabetes mellitus (T2DM). Inadequate adherence has been linked to decreased glycemic control and increased healthcare costs and hospitalizations. We examined the impact of real-world adherence on glycemic control in T2DM patients treated with canagliflozin. This retrospective study used US administrative claims data from commercial and Medicare Advantage healthcare enrollees. Study subjects were adult T2DM patients with baseline HbA1c ≥7.0% and a pharmacy claim for canagliflozin between April 01, 2013 and August 31, 2014. Outcomes included treatment patterns, HbA1c reductions and goal attainment, pharmacy costs, and patient characteristics. Adherence, measured by the proportion of days covered (PDC), was calculated as the number of days of canagliflozin availability divided by the length of the follow-up period. Results were analyzed overall and compared between patients who were highly adherent (HA) (PDC ≥0.8) versus less than highly adherent (LHA) (PDC <0.8). The study population included 2261 patients. At the end of follow-up, patients had an overall mean reduction in HbA1c of 0.97%. Those HA had larger reductions in HbA1c than those LHA (1.17% versus 0.73%, respectively, p<0.001); 24.6% and 59.4% of patients achieved HbA1c goals of <7.0% and <8.0%, respectively. Highly adherent patients were more likely to achieve goals than those LHA. Less than highly adherent patients increased insulin use by 5.4% in the follow-up period, while HA patients decreased the use of most oral AHAs and had no change in insulin use. Patients had an HbA1c reduction of 0.97% in the 12months following the first canagliflozin fill. Highly adherent patients achieved a greater reduction in HbA1c at the end of the follow-up period and were more likely to reach HbA1c goals. Highly adherent patients also had reductions in the use of most oral AHAs, while LHA patients saw a small increase in insulin use.

Predictors of Insulin Resistance in Obesity and Type 2 Diabetes Mellitus - The Role of Magnesium

Objectives: Hypomagnesaemia and insulin resistance are two major clinical problems, with intertwining pathophysiology. We aimed to explore this association in obese patients and in non-insulin-treated patients with type 2 diabetes mellitus (T2DM). Methods: Subjects were recruited from the outpatient diabetes/obesity clinic of the Antwerp University Hospital. The population (N=2731) consists of 2 subject groups with different degrees of insulin resistance and insulin secretory potential: 1) overweight (Body Mass index (BMI) ≥ 25 kg/m² and <30 kg/m²) and obese (BMI ≥ 30 kg/m²) subjects, 2) adult T2DM patients. Hypomagnesaemia was defined as serum magnesium <1.7 mg/dl. Insulin resistance was estimated using the Homeostasis model assessment (HOMA-IR; cut-off point 2.82). Results: Hypomagnesaemia was present in 6.1% of the entire population. Patients with hypomagnesaemia had more visceral adipose tissue (VAT), and a higher HOMA-IR. They suffered more from the metabolic syndrome and T2DM. Patients with a HOMA-IR<2.82 were younger, had lower BMI and less VAT. They suffered less from hypomagnesaemia. Hypomagnesaemia was more prevalent in T2DM patients than in obese subjects without T2DM. Although serum magnesium and HOMA-IR were negatively correlated, logistic regression analysis showed that magnesium was not a significant predictor for HOMA-IR. Conclusions: Despite a significant negative correlation between magnesium and HOMA-IR, magnesium was not retained as a significant determinant of insulin resistance compared to the other predictors in our population of obese subjects and T2DM patients.

The pharmacokinetics and pharmacodynamics of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus

PurposeThe aim of this study is to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of a single 12.5- or 25-mg dose of alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, in pediatric (children and adolescents) and adult subjects with type 2 diabetes mellitus (T2DM).MethodsA randomized, open-label, multicenter study was conducted in pediatric and adult subjects. Subjects in two pediatric groups (children and adolescents) were randomized 1:1 to receive a single oral dose of alogliptin 12.5 or 25 mg, respectively; all gender- and race-matched adult subjects received alogliptin 25 mg. Blood and urine samples were collected at prespecified time points for PK/PD analyses. A PK/PD model was developed using data from the study for steady-state simulations. Safety was also assessed.ResultsIn pediatric subjects receiving the 25-mg dose, the mean alogliptin peak plasma concentrations (Cmax) and AUC0-inf values were 26 and 23% lower, respectively, than in adults receiving the 25-mg dose, but maximum observed DPP-4 inhibition effect (Emax) and AUEC0–24 values were similar to those in adults. In pediatric subjects receiving the 12.5-mg dose, the mean alogliptin Cmax and AUC0-inf values were 58 and 54% lower, respectively, than those in adults, hence Emax and AUEC0–24 values were also lower by 11 and 17%, respectively. The PK/PD model simulated data were consistent with study results. No safety concern was found.ConclusionsA 25-mg dose of alogliptin in pediatric subjects achieved alogliptin exposures and DPP-4 inhibition similar to those in adult T2DM patients without safety concerns; therefore, this dose is recommended for a pediatric phase 3 trial.

Short- and Long-Term Effects of Wholegrain Oat Intake on Weight Management and Glucolipid Metabolism in Overweight Type-2 Diabetics: A Randomized Control Trial.

Glycemic control and weight reduction are primary goals for the management of overweight and obese type 2 diabetes mellitus (T2DM). Effective management cannot be achieved without an appropriate diet. Our study aimed to evaluate the short- and long-term effects of oat intake and develop a reasonable dietary plan for overweight T2DM patients. A randomized control trial, registered under ClinicalTrials.gov (Identification code: NCT01495052), was carried out among adult T2DM patients. A subgroup of 298 overweight subjects was selected and received a 30-day centralized intervention and 1-year free-living follow-up. Participants were randomly allocated to one of the following four groups. The usual care group (n = 60) received no intervention; the healthy diet group (n = 79) received a low-fat and high-fiber diet (“healthy diet”); the 50 g-oats group (n = 80) and 100 g-oats group (n = 79) received the “healthy diet” with the same amount of cereals replaced by 50 g and 100 g oats respectively. Anthropometric, blood glycemic and lipid variables were measured. For the 30-day intervention, significant differences in the changes of FPG (fasting plasma glucose), PPG (postprandial plasma glucose), HbA1c (glycosylated hemoglobin), HOMA-IR (homeostasis model assessment of insulin resistance), TC (total cholesterol), TG (total triglycerides), and LDL-c (low-density lipoprotein cholesterol) were observed among the four groups. Compared to the healthy diet group, the 50 g-oats group had a bigger reduction in PPG (mean difference (MD): −1.04 mmol/L; 95% CI: −2.03, −0.05) and TC (MD: −0.24 mmol/L; 95% CI: −0.47, −0.01); the 100 g-oats group had a bigger reduction in PPG (MD: −1.48 mmol/L; 95% CI: −2.57, −0.39), HOMA-IR (MD: −1.77 mU·mol/L2; 95% CI: −3.49, −0.05), TC (MD: −0.33 mmol/L; 95% CI: −0.56, −0.10) and LDL-c (MD: −0.22 mmol/L; 95% CI: −0.41, −0.03). In the 1-year follow-up, greater effects in reducing weight (MD: −0.89 kg; 95% CI: −1.56, −0.22), HbA1c (MD: −0.64%; 95% CI: −1.19, −0.09) and TG (MD: −0.70 mmol/L; 95% CI: −1.11, −0.29) were observed in the 100 g-oats group. In conclusion, short- and long-term oat intake had significant effects on controlling hyperglycemia, lowering blood lipid and reducing weight. Our study provided some supportive evidence for recommending oat as a good whole grain selection for overweight diabetics.

Screening for coeliac disease in adult patients with type 1 diabetes mellitus: myths, facts and controversy.

This review aims at summarizing the present knowledge on the clinical consequences of concomitant coeliac disease (CD) in adult patients with type 1 diabetes mellitus (T1DM). The cause of the increased prevalence of CD in T1DM patients is a combination of genetic and environmental factors. Current screening guidelines for CD in adult T1DM patients are not uniform. Based on the current evidence of effects of CD on bone mineral density, diabetic complications, quality of life, morbidity and mortality in patients with T1DM, we advise periodic screening for CD in adult T1DM patients to prevent delay in CD diagnosis and subsequent CD and/or T1DM related complications.

Diabetes-Related Distress, Depression and Distress-Depression among Adults with Type 2 Diabetes Mellitus in Malaysia.

Type 2 diabetes mellitus (T2DM) brings about an increasing psychosocial problem in adult patients. Prevalence data on and associated factors of diabetes related distress (DRD) and depression have been lacking in Asia. This study aimed to examine the prevalence of DRD and depression, and their associated factors in Asian adult T2DM patients. This study was conducted in three public health clinics measuring DRD (Diabetes Distress Scale, DDS), and depression (Patient Health Questionnaire, PHQ). Patients who were at least 30 years of age, had T2DM for more than one year, with regular follow-up and recent laboratory results (< 3 months) were consecutively recruited. Associations between DRD, depression and the combination DRD-depression with demographic and clinical characteristics were analysed using generalized linear models. From 752 invited people, 700 participated (mean age 56.9 years, 52.8% female, 52.9% Malay, 79.1% married). Prevalence of DRD and depression were 49.2% and 41.7%, respectively. Distress and depression were correlated, spearman’s r = 0.50. Patients with higher DRD were younger (OR 0.995, 95% CI 0.996 to 0.991), Chinese (OR 1.2, 95% CI 1.04 to 1.29), attending Dengkil health clinic (OR 1.1, 95% CI 1.00 to 1.22) and had higher scores on the PHQ (OR 1.1, 95% CI 1.04 to 1.06). Depression was less likely in the unmarried compared to divorced/separately living and those attending Dengkil health clinic, but more likely in patients with microvascular complications (OR 1.4, 95% CI 1.06 to 1.73) and higher DDS (OR 1.03, 95% CI 1.02 to 1.03). For the combination of DRD and depression, unemployment (OR 4.7, 95% CI 1.02 to 21.20) had positive association, whereas those under medical care at the Salak health clinics (OR 0.28, 95% CI 0.12 to 0.63), and those with a blood pressure > 130/80 mmHg (OR 0.53, 95% CI 0.32 to 0.89) were less likely to experience both DRD and depression. DRD and depression were common and correlated in Asian adults with T2DM at primary care level. Socio-demographic more than clinical characteristics were related to DRD and depression.

Real-world evaluation of glycemic control among patients with type 2 diabetes mellitus treated with canagliflozin versus dipeptidyl peptidase-4 inhibitors

Objective To evaluate glycemic control among patients with type 2 diabetes mellitus (T2DM) treated with canagliflozin (CANA) vs. dipeptidyl peptidase-4 (DPP-4) inhibitors.Methods Using integrated claims and lab data from a US health plan of commercial and Medicare Advantage enrollees, this matched-control cohort study assessed adult T2DM patients receiving treatment with CANA or DPP-4 inhibitors (1 April 2013–31 December 2013). Cohorts were chosen hierarchically; the first pharmacy claim for CANA was identified as the index date; then the first pharmacy claim for a DPP-4 inhibitor was identified and index date set. Eligible patients had 6 months of continuous health plan enrollment before the index date (baseline) and 9 months after (follow-up) and no evidence of index drug in baseline. Patients were matched 1:1 using propensity score matching. Changes in glycated hemoglobin (HbA1c) and percentages of patients with HbA1c <8% and <7% during the follow-up were evaluated.Results The matched CANA and DPP-4 inhibitor cohorts (53.2% treated with sitagliptin) included 2766 patients each (mean age: 55.7 years). Among patients with baseline and follow-up HbA1c results, mean baseline HbA1c values were similar, 8.62% and 8.57% (p = 0.615) for the CANA (n = 729) and DPP-4 inhibitor (n = 710) cohorts, respectively. Change in HbA1c was greater among patients in the CANA cohort than for those in the DPP-4 inhibitor cohort (−0.92% vs. −0.63%, p < 0.001), and also among the subset of patients with baseline HbA1c ≥7% (-1.07% [n = 624] vs. −0.79% [n = 603], p = 0.004). During follow-up, greater percentages of the CANA cohort relative to the DPP-4 inhibitor cohort achieved HbA1c of <8% (66.0% vs. 58.6%, p = 0.004) and <7% (35.4% vs. 29.9%, p = 0.022).Limitations This study was observational and residual confounding remains a possibility.Conclusions In this real-world study of patients with T2DM, CANA use was associated with greater HbA1c reduction and higher percentages of patients attaining HbA1c goals than those treated with DPP-4 inhibitors.

Platelet Dysfunction in Type 1 Diabetes: Stressing the Thromboxanes.

Overall death from cardiovascular disease (CVD) has declined over the past 20 years; yet, the population with diabetes has seen minimal benefit (1,2). When broken out by diabetes type, individuals with type 1 diabetes mellitus (T1DM) have approximately a 10-fold age-adjusted increased risk of CVD, even higher than that observed in those with type 2 diabetes mellitus (T2DM), with women being more affected then men (3,4). This is in the face of drastically improved insulin therapy regimens over the past decades, suggesting that hyperglycemia itself may not explain this increased CVD. Paradoxically, though, high-quality clinical studies regarding the risks of CVD in T1DM and the potential mechanisms underlying this pathophysiology remain woefully underrepresented as compared with similar studies related to individuals with T2DM, who are known to have persistently elevated platelet reactivity and a depressed inhibitory response to aspirin (5,6). Furthermore, the published studies that do exist are performed variably on pediatric and adult T1DM patients and show highly conflicting results (7–14). Taken together, the current state of the field is a hindrance to the proper care and treatment of individuals with T1DM. A number of risk factors have been proposed to elevate CVD risk in T1DM patients, including hyperglycemia, dyslipidemia, inflammation, oxidative stress, and genetics, among others (3). A significant contributing factor to the diabetic prothrombotic state is the aberrant regulation of antiplatelet-activating mechanisms that normally maintain high levels of inhibitory cAMP to prevent aggregation (1). Molecules directly affecting platelet cAMP production are the arachidonic acid metabolites thromboxane A2 (TXA2) and prostacyclin (PGI2). TXA2 …

Is Urinary NGAL Determination Useful for Monitoring Kidney Function and Assessment of Cardiovascular Disease? A 12-Month Observation of Patients with Type 2 Diabetes.

Background. Diabetic kidney disease (DKD) may start as glomerular or tubular damage. We assessed kidney function during one-year-long observation of patients with type 2 diabetes mellitus (T2DM) after initiation of nephroprotective treatment, with emphasis on the changes in urinary neutrophil gelatinase-associated lipocalin (uNGAL), and evaluated the association between tubular damage and cardiovascular complications of T2DM. Materials and Methods. Adult T2DM patients (55) were assessed initially and 30 patients after 1 year. Albumin and uNGAL and creatinine were measured in first morning urine. Albumin/creatinine (uACR) and uNGAL/creatinine (uNCR) ratios were calculated. Results. In logistic regression, both uACR above 30 mg/g and uNCR the median (21.3 μg/g) were associated with cardiovascular complications, independently of classical risk factors and diabetes duration. One year after initiation of treatment, a significant reduction in HbA1c was observed. BMI and lipid profiles did not change. Increase in serum creatinine and reduction in eGFR occurred, along with decrease in uNGAL and uNCR. Increasing uNCR and uACR were associated with higher control HbA1c. The increase in uNCR was more frequent in patients with hypertension. Conclusions. Better glycemic control in T2DM patients results in improved tubular function, as reflected by reduced uNCR and uNGAL. First morning urine uNGAL and uNCR may be useful to assess renal function and cardiovascular risk, along with albuminuria and eGFR.

Vitamin D deficiency and its correlation to hemoglobin A1C in adolescent and young adult type 1 diabetes mellitus patients

Background Some studies have described the relationship between autoimmune diabetes or type 1 diabetes mellitus (T1DM) and vitamin D deficiency. Few studies correlate between vitamin D deficiency and glycemic control. Purpose This study was conducted to appraise the status of vitamin D in adolescent and young adult T1DM patients and to correlate its deficiency to glycated hemoglobin (HbA1c). Patients and methods Around 63 Kuwaiti patients with T1DM were recruited in a descriptive cross-sectional study in April 2015. Serum level of vitamin D [25(OH)D] was measured using enzyme-linked immunosorbent assay, and glycemic control was measured by HbA1c using autoanalyzer. The relationship between vitamin D levels and HbA1c was analyzed by Spearman’s correlation. Among the participants, 21 (33.3%) were male and 42 (66.7%) were female. The mean age was 18.41±6.19, and the mean diabetes duration was 6.98±4.99. The mean vitamin D concentration was 47.29±2.91 nmol/l, with 38.1% of participants identified to have vitamin D deficiency and 19% identified to have vitamin D insufficiency. There were high levels of HbA1c (10.08±2.28), with a significant inverse correlation between HbA1c and vitamin D (r=−0.374 and P=0.003). Conclusion Low vitamin D in T1DM is extremely highly and closely correlated to HbA1c. We recommend that evaluation of the level of vitamin D in type 1 diabetic patients is very critical, and vitamin D supplementation may improve glycemic control.

Cardiovascular risk factors and determinants of clinical outcomes in type 2 diabetic patients at a tertiary-care centre

Background: The prevalence of type 2 diabetes mellitus (T2DM) is growing rapidly worldwide. The global burden of T2DM in 2013 was 382 million and projected to 592 million by 2035, accounting for 7.8% of the adult population. The objective of this study was to record treatments, risk factor control, determinants of glycaemic control and cardiovascular outcomes in type 2 diabetes (T2DM). Methods: We included adult T2DM patients and followed up for 6 months. Patients were categorised into good (HbA1c 8.5%). We used multiple logistic regression to identify determinants of glycaemic control and outcomes. Results: We recruited 785 patients with a mean age of 55.43 (±11.1) years, and 43.8% were women. At baseline, patients with poor control (45%) were younger and from lower socioeconomic strata (73.5%). At 6 months, the American Diabetes Association (ADA) targets of HbA1c was met only in 27.52%, systolic blood pressure (SBP) in 81.47% and low density lipoprotein (LDL) cholesterol in 48.86% patients. Patients with sedentary or low physical activity (Odds ratio 11.51, 95% confidence interval 3.48, 37.98; p<0.001) and with diabetes for a longer duration (OR 1.14 [1.07-1.22], p<0.001) were more likely to be in poor glucose control. Patients having sedentary or low physical activity (OR 6.66 [1.730-25.63] p = 0.006) and higher LDL cholesterol (OR 1.04 [1.01-1.07], p = 0.008) were more likely to get microvascular complications. Conclusions: Management of modifiable risk factors and early control of hyperglycaemia should be given more importance.

Diabetes distress in adult type 1 diabetes mellitus men and women with disease onset in childhood and in adulthood

The aimTo determine whether or not diabetes distress varies by age of type 1 diabetes mellitus (T1DM) onset and/or gender. Subjects and MethodsA total of 700 adult T1DM patients were randomly selected from the Lithuanian Diabetes Registry; 214 of them (30.6%) agreed to participate and were recruited for the study. Diabetes distress (emotional burden, physician-related distress, regimen-related distress, interpersonal distress) was compared in 105 (42 men and 63 women) patients with T1DM diagnosed during 0–18years of life, and in 109 (61 men and 48 women) with T1DM diagnosed in adulthood, using Diabetes Distress Scale (DDS). ResultsAdult childhood-onset T1DM women have higher regimen-related distress (36.3±21.3 vs 26.6±16.2, p=0.016) than adulthood-onset women.Adult childhood-onset T1DM women experience higher diabetes distress (higher emotional burden (27.0±22.0 vs 15.6±16.4, p=0.006), physician-related distress (34.4±33.9 vs 20.7±29.4, p=0.024), total diabetes distress (41.2±13.6 vs 34.8±10.9, p=0.011)) than childhood-onset men. Adulthood-onset T1DM women experience higher physician-related distress (39.2±37.6 vs 23.4±32.5, p=0.013), but lower regimen-related distress (26.6±16.2 vs 35.8±21.6, p=0.014) than adulthood-onset men.In conclusion our findings reinforce the interdependence of psychological and biomedical factors in influencing health outcomes and support the need to provide psychological assessment and support to patients with T1DM.

Blood electrolyte disturbances during severe hypoglycemia in Korean patients with type 2 diabetes.

Background/Aims:To investigate abnormalities in blood electrolyte levels during severe hypoglycemia in Korean patients with type 2 diabetes mellitus (T2DM) in a clinical setting.Methods:Blood electrolyte levels in adult T2DM patients during severe hypoglycemia were collected from January 1, 2008 to December 31, 2012. Patients who maintained normal serum creatinine and blood urea nitrogen levels were utilized in the study. Severe hypoglycemia was defined as a condition requiring medical assistance, such as administering carbohydrates when serum glucose levels less than 70 mg/dL were observed, in conjunction with other symptoms of hypoglycemia.Results:A total of 1,068 patients who visited the emergency room with severe hypoglycemia were screened, of which 219 patients were included in this study. The incidence of abnormal levels for any electrolyte was 47%. Hypokalemia (< 3.5 mmol/L) was the most common type of electrolyte disturbance observed at 21.9%. A decrease in serum potassium levels was associated with decreases in blood glucose levels (r = 0.151, p = 0.025). During severe hypoglycemia, median blood glucose levels, incidence of tachycardia (> 100 beats per minute) and severe hypertension (≥ 180/120 mmHg) were 30 mg/dL (range, 14 to 62) and 35 mg/dL (range, 10 to 69; p = 0.04), 18.8% and 7.2% (p = 0.02), and 20.8% and 10.2% (p = 0.05) in the hypokalemia and normokalemia groups, respectively. Conclusions:During severe hypoglycemia, hypokalemia occurred in 21.9% of T2DM patients and was associated with tachycardia and severe hypertension. Therefore, the results suggest that severe hypoglycemia may increase cardiovascular events in T2DM.