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Prognostic Significance of Long-term HbA1c Variability for All-Cause Mortality in the ACCORD Trial

OBJECTIVE

The association between high glycemic variability and all-cause mortality has been widely investigated in epidemiological studies but rarely validated in glucose-lowering clinical trials. We aimed to identify the prognostic significance of visit-to-visit HbA1c variability in treated patients in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial population.

RESEARCH DESIGN AND METHODS

We studied the risk of all-cause mortality in relation to long-term visit-to-visit HbA1c variability, expressed as coefficient of variation (CV), variability independent of the mean (VIM), and average real variability (ARV), from the 8th month to the transition. Multivariable Cox proportional hazards models were used to estimate adjusted hazard ratio (HR) and 95% CI.

RESULTS

Compared with the standard therapy group (n = 4,728), the intensive therapy group (n = 4,755) had significantly lower mean HbA1c (6.6% [49 mmol/mol] vs. 7.7% [61 mmol/mol], P < 0.0001) and lower CV, VIM, and ARV (P < 0.0001). In multivariate adjusted analysis, all three HbA1c variability indices were significantly associated with total mortality in all patients as well as in the standard- and intensive-therapy groups analyzed separately. The hazard ratios for a 1-SD increase in HbA1c variability indices for the all-cause mortality were 1.19 and 1.23 in intensive and standard therapy, respectively. Cross-tabulation analysis showed the third tertile of HbA1c mean and VIM had significantly higher all-cause mortality (HR 2.05; 95% CI, 1.17–3.61; P < 0.01) only in the intensive-therapy group.

CONCLUSIONS

Long-term visit-to-visit HbA1c variability was a strong predictor of all-cause mortality. HbA1c VIM combined with HbA1c mean conferred an increased risk for all-cause mortality in the intensive-therapy group.




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2017 American Academy of Pediatrics Clinical Practice Guideline: Impact on Prevalence of Arterial Hypertension in Children and Adolescents With Type 1 Diabetes

OBJECTIVE

In 2017, the American Academy of Pediatrics introduced a new guideline (2017 Clinical Practice Guideline of the American Academy of Pediatrics [AAP 2017]) to diagnose arterial hypertension (HTN) in children that included revised, lower normative blood pressure (BP) values and cut points for diagnosing high BP in adolescents. We studied the impact of the new AAP 2017 guideline on prevalence of HTN in children with type 1 diabetes mellitus (T1DM).

RESEARCH DESIGN AND METHODS

Up to September 2018, 1.4 million office BP measurements in 79,849 children and adolescents (aged 5–20 years) with T1DM have been documented in the DPV (Diabetes Prospective Follow-up) registry. BP values of the most recent year were aggregated, and BP values of 74,677 patients without antihypertensive medication were analyzed (median age 16 years and diabetes duration 5.3 years and 52.8% boys). BP values were classified according to AAP 2017 and the references of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS) (2011) and the Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents (fourth report) (2004).

RESULTS

Of the patients, 44.1%, 29.5%, and 26.5% were hypertensive according to AAP 2017, KiGGS, and fourth report, respectively. Differences in prevalence of HTN were strongly age dependent: <10 years, AAP 2017 31.4%, KiGGS 30.7%, fourth report 19.6%; 10 to <15 years, AAP 2017 30.9%, KiGGS 31.2%, fourth report 22.4%; and ≥15 years, AAP 2017 53.2%, KiGGS 28.4%, fourth report 30.0%. Among teenagers ≥15 years, 59.1% of boys but only 46.3% of girls were classified as hypertensive by AAP 2017 but only 21.1%/26% of boys and 36.7%/34.4% of girls by KiGGS/fourth report, respectively.

CONCLUSIONS

Classification of BP as hypertension depends strongly on the normative data used. Use of AAP 2017 results in a significant increase in HTN in teenagers ≥15 years with T1DM, particularly in boys. AAP 2017 enhances the awareness of elevated BP in children, particularly in patients with increased risk for cardiovascular disease.




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Use of Antihyperglycemic Medications in U.S. Adults: An Analysis of the National Health and Nutrition Examination Survey

OBJECTIVE

1) To examine trends in the use of diabetes medications and 2) to determine whether physicians individualize diabetes treatment as recommended by the American Diabetes Association (ADA).

RESEARCH DESIGN AND METHODS

We conducted a retrospective, cross-sectional analysis of 2003–2016 National Health and Nutrition Examination Survey (NHANES) data. We included people ≥18 years who had ever been told they had diabetes, had an HbA1C >6.4%, or had a fasting plasma glucose >125 mg/dL. Pregnant women, and those aged <20 years receiving only insulin were excluded. We assessed trends in use of ADA’s seven preferred classes from 2003–2004 to 2015–2016. We also examined use by hypoglycemia risk (sulfonylureas, insulin, and meglitinides), weight effect (sulfonylureas, thiazolidinediones [TZDs], insulin, and meglitinides), cardiovascular benefit (canagliflozin, empagliflozin, and liraglutide), and cost (brand-name medications and insulin analogs).

RESULTS

The final sample included 6,323 patients. The proportion taking any medication increased from 58% in 2003–2004 to 67% in 2015–2016 (P < 0.001). Use of metformin and insulin analogs increased, while use of sulfonylureas, TZDs, and human insulin decreased. Following the 2012 ADA recommendation, the choice of drug did not vary significantly by older age, weight, or presence of cardiovascular disease. Patients with low HbA1C, or HbA1C <6%, and age ≥65 years were less likely to receive hypoglycemia-inducing medications, while older patients with comorbidities were more likely. Insurance, but not income, was associated with the use of higher-cost medications.

CONCLUSIONS

Following ADA recommendations, the use of metformin increased, but physicians generally did not individualize treatment according to patients’ characteristics. Substantial opportunities exist to improve pharmacologic management of diabetes.




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Risk of Major Adverse Cardiovascular Events, Severe Hypoglycemia, and All-Cause Mortality for Widely Used Antihyperglycemic Dual and Triple Therapies for Type 2 Diabetes Management: A Cohort Study of All Danish Users

OBJECTIVE

The vast number of antihyperglycemic medications and growing amount of evidence make clinical decision making difficult. The aim of this study was to investigate the safety of antihyperglycemic dual and triple therapies for type 2 diabetes management with respect to major adverse cardiovascular events, severe hypoglycemia, and all-cause mortality in a real-life clinical setting.

RESEARCH DESIGN AND METHODS

Cox regression models were constructed to analyze 20 years of data from the Danish National Patient Registry with respect to effect of the antihyperglycemic therapies on the three end points.

RESULTS

A total of 66,807 people with type 2 diabetes were treated with metformin (MET) including a combination of second- and third-line therapies. People on MET plus sulfonylurea (SU) had the highest risk of all end points, except for severe hypoglycemia, for which people on MET plus basal insulin (BASAL) had a higher risk. The lowest risk of major adverse cardiovascular events was seen for people on a regimen including a glucagon-like peptide 1 (GLP-1) receptor agonist. People treated with MET, GLP-1, and BASAL had a lower risk of all three end points than people treated with MET and BASAL, especially for severe hypoglycemia. The lowest risk of all three end points was, in general, seen for people treated with MET, sodium–glucose cotransporter 2 inhibitor, and GLP-1.

CONCLUSIONS

Findings from this study do not support SU as the second-line treatment choice for patients with type 2 diabetes. Moreover, the results indicate that adding a GLP-1 for people treated with MET and BASAL could be considered, especially if those people suffer from severe hypoglycemia.




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Dapagliflozin Versus Placebo on Left Ventricular Remodeling in Patients With Diabetes and Heart Failure: The REFORM Trial

OBJECTIVE

To determine the effects of dapagliflozin in patients with heart failure (HF) and type 2 diabetes mellitus (T2DM) on left ventricular (LV) remodeling using cardiac MRI.

RESEARCH DESIGN AND METHODS

We randomized 56 patients with T2DM and HF with LV systolic dysfunction to dapagliflozin 10 mg daily or placebo for 1 year, on top of usual therapy. The primary end point was difference in LV end-systolic volume (LVESV) using cardiac MRI. Key secondary end points included other measures of LV remodeling and clinical and biochemical parameters.

RESULTS

In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling. However, it reduced diastolic blood pressure and loop diuretic requirements while increasing hemoglobin, hematocrit, and ketone bodies. There was a trend toward lower weight.

CONCLUSIONS

We were unable to determine with certainty whether dapagliflozin in patients with T2DM and HF had any effect on LV remodeling. Whether the benefits of dapagliflozin in HF are due to remodeling or other mechanisms remains unknown.




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Novel Use of GLP-1 Receptor Agonist Therapy in HNF4A-MODY




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Wilson Disease With Novel Compound Heterozygote Mutations in the ATP7B Gene Presenting With Severe Diabetes

OBJECTIVE

To determine the relationship between ATP7B mutations and diabetes in Wilson disease (WD).

RESEARCH DESIGN AND METHODS

A total of 21 exons and exon-intron boundaries of ATP7B were identified by Sanger sequencing.

RESULTS

Two novel compound heterozygous mutations (c.525 dupA/ Val176Serfs*28 and c.2930 C>T/ p.Thr977Met) were detected in ATP7B. After d-penicillamine (D-PCA) therapy, serum aminotransferase and ceruloplasmin levels in this patient were normalized and levels of HbA1c decreased. However, when the patient ceased to use D-PCA due to an itchy skin, serum levels of fasting blood glucose increased. Dimercaptosuccinic acid capsules were prescribed and memory recovered to some extent, which was accompanied by decreased insulin dosage for glucose control by 5 units.

CONCLUSIONS

This is the first report of diabetes caused by WD.




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Cost and Cost-Effectiveness of Large-Scale Screening for Type 1 Diabetes in Colorado

OBJECTIVE

To assess the costs and project the potential lifetime cost-effectiveness of the ongoing Autoimmunity Screening for Kids (ASK) program, a large-scale, presymptomatic type 1 diabetes screening program for children and adolescents in the metropolitan Denver region.

RESEARCH DESIGN AND METHODS

We report the resource utilization, costs, and effectiveness measures from the ongoing ASK program compared with usual care (i.e., no screening). Additionally, we report a practical screening scenario by including utilization and costs relevant to routine screening in clinical practice. Finally, we project the potential cost-effectiveness of ASK and routine screening by identifying clinical benchmarks (i.e., diabetic ketoacidosis [DKA] events avoided, HbA1c improvements vs. no screening) needed to meet value thresholds of $50,000–$150,000 per quality-adjusted life-year (QALY) gained over a lifetime horizon.

RESULTS

Cost per case detected was $4,700 for ASK screening and $14,000 for routine screening. To achieve value thresholds of $50,000–$150,000 per QALY gained, screening costs would need to be offset by cost savings through 20% reductions in DKA events at diagnosis in addition to 0.1% (1.1 mmol/mol) improvements in HbA1c over a lifetime compared with no screening for patients who develop type 1 diabetes. Value thresholds were not met from avoiding DKA events alone in either scenario.

CONCLUSIONS

Presymptomatic type 1 diabetes screening may be cost-effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved HbA1c persist over long-run time horizons. As more data are collected from ASK, the model will be updated with direct evidence on screening effects.




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Blood Pressure Variability and Risk of Heart Failure in ACCORD and the VADT

OBJECTIVE

Although blood pressure variability is increasingly appreciated as a risk factor for cardiovascular disease, its relationship with heart failure (HF) is less clear. We examined the relationship between blood pressure variability and risk of HF in two cohorts of type 2 diabetes participating in trials of glucose and/or other risk factor management.

RESEARCH DESIGN AND METHODS

Data were drawn from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial and the Veterans Affairs Diabetes Trial (VADT). Coefficient of variation (CV) and average real variability (ARV) were calculated for systolic (SBP) and diastolic blood pressure (DBP) along with maximum and cumulative mean SBP and DBP during both trials.

RESULTS

In ACCORD, CV and ARV of SBP and DBP were associated with increased risk of HF, even after adjusting for other risk factors and mean blood pressure (e.g., CV-SBP: hazard ratio [HR] 1.15, P = 0.01; CV-DBP: HR 1.18, P = 0.003). In the VADT, DBP variability was associated with increased risk of HF (ARV-DBP: HR 1.16, P = 0.001; CV-DBP: HR 1.09, P = 0.04). Further, in ACCORD, those with progressively lower baseline blood pressure demonstrated a stepwise increase in risk of HF with higher CV-SBP, ARV-SBP, and CV-DBP. Effects of blood pressure variability were related to dips, not elevations, in blood pressure.

CONCLUSIONS

Blood pressure variability is associated with HF risk in individuals with type 2 diabetes, possibly a consequence of periods of ischemia during diastole. These results may have implications for optimizing blood pressure treatment strategies in those with type 2 diabetes.




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Commercially Available Insulin Products Demonstrate Stability Throughout the Cold Supply Chain Across the U.S.

OBJECTIVE

A recent publication questioned the integrity of insulin purchased from U.S. retail pharmacies. We sought to independently validate the method used, isotope dilution solid-phase extraction (SPE) liquid chromatography mass spectrometry (LC-MS), and expand analysis to two U.S. Pharmacopeia (USP) methods (high-performance LC with ultraviolet detection and LC-MS).

RESEARCH DESIGN AND METHODS

Each method was used to evaluate nine insulin formulations, purchased at four pharmacies, within five geographic locations in the U.S.

RESULTS

All human and analog insulins measured by the USP methods (n = 174) contained the expected quantity of active insulin (100 ± 5 units/mL). When using isotope dilution SPE-LC-MS, units-per-milliliter values were well below product labeling due to unequal recovery of the internal standard compared with target insulin.

CONCLUSIONS

Insulin purchased from U.S. pharmacies is consistent with product labeling.




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Use of Glucagon-Like Peptide 1 Receptor Agonists and Risk of Serious Renal Events: Scandinavian Cohort Study

OBJECTIVE

To assess the association between use of glucagon-like peptide 1 (GLP-1) receptor agonists and risk of serious renal events in routine clinical practice.

RESEARCH DESIGN AND METHODS

This was a cohort study using an active-comparator, new-user design and nationwide register data from Sweden, Denmark, and Norway during 2010–2016. The cohort included 38,731 new users of GLP-1 receptor agonists (liraglutide 92.5%, exenatide 6.2%, lixisenatide 0.7%, and dulaglutide 0.6%), matched 1:1 on age, sex, and propensity score to a new user of the active comparator, dipeptidyl peptidase 4 (DPP-4) inhibitors. The main outcome was serious renal events, a composite including renal replacement therapy, death from renal causes, and hospitalization for renal events. Secondary outcomes were the individual components of the main outcome. Hazard ratios (HRs) were estimated using Cox models and an intention-to-treat exposure definition. Mean (SD) follow-up time was 3.0 (1.7) years.

RESULTS

Mean (SD) age of the study population was 59 (10) years, and 18% had cardiovascular disease. A serious renal event occurred in 570 users of GLP-1 receptor agonists (incidence rate 4.8 events per 1,000 person-years) and in 722 users of DPP-4 inhibitors (6.3 events per 1,000 person-years, HR 0.76 [95% CI 0.68–0.85], absolute difference –1.5 events per 1,000 person-years [–2.1 to –0.9]). Use of GLP-1 receptor agonists was associated with a significantly lower risk of renal replacement therapy (HR 0.73 [0.62–0.87]) and hospitalization for renal events (HR 0.73 [0.65–0.83]) but not death from renal causes (HR 0.72 [0.48–1.10]). When we used an as treated exposure definition in which patients were censored at treatment cessation or switch to the other study drug, the HR for the primary outcome was 0.60 (0.49–0.74).

CONCLUSIONS

In this large cohort of patients seen in routine clinical practice in three countries, use of GLP-1 receptor agonists, as compared with DPP-4 inhibitors, was associated with a reduced risk of serious renal events.




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Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial

OBJECTIVE

To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).

RESEARCH DESIGN AND METHODS

In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58–86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA1c at week 26.

RESULTS

Change in HbA1c from baseline to week 26 was significantly greater with iGlarLixi (–1.58% [–17.3 mmol/mol]) than with Lixi (–0.51% [–5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference –1.07% [–11.7 mmol/mol], P < 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA1c <7% (53 mmol/mol) (65.2% vs. 19.4%; P < 0.0001), and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference –2.29 mmol/L [–41.23 mg/dL], P < 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.

CONCLUSIONS

This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.




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Decreased Vagal Activity and Deviation in Sympathetic Activity Precedes Development of Diabetes

OBJECTIVE

The objective of this study was to examine whether altered heart rate variability (HRV) could predict the risk of diabetes in Asians.

RESEARCH DESIGN AND METHODS

A cohort study was conducted in 54,075 adults without diabetes who underwent 3-min HRV measurement during health checkups between 2011 and 2014 at Kangbuk Samsung Hospital. We analyzed the time domain (SD of the normal-to-normal interval [SDNN] and root mean square differences of successive normal-to-normal interval [RMSSD]) and the frequency domain (total power, normalized low-frequency power [LF], and normalized high-frequency power [HF] and LF/HF ratio). We compared the risk of diabetes until 2017 according to tertiles of heart rate and HRV variables, with tertile 1 serving as the reference group.

RESULTS

During 243,758.2 person-years, 1,369 subjects were diagnosed with diabetes. Both time and frequency domain variables were lower in the group with diabetes, with the exception of those with normalized LF and LF/HF ratio. In Cox analysis, as SDNN, RMSSD, and normalized HF tertiles increased, the risk of diabetes decreased (hazard ratios [95% CIs] of tertile 3: 0.81 [0.70–0.95], 0.76 [0.65–0.90], and 0.78 [0.67–0.91], respectively), whereas the risk of diabetes increased in the case of heart rate, normalized LF, and LF/HF ratio (hazard ratios [95% CIs] of tertile 3: 1.41 [1.21–1.65], 1.32 [1.13–1.53], and 1.31 [1.13–1.53), respectively) after adjusting for age, sex, BMI, smoking, drinking, systolic blood pressure, lipid level, CRP, and HOMA of insulin resistance.

CONCLUSIONS

Abnormal HRV, especially decreased vagal activity and deviation in sympathovagal imbalance to sympathetic activity, might precede incident diabetes.




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Obstructive Sleep Apnea, a Risk Factor for Cardiovascular and Microvascular Disease in Patients With Type 2 Diabetes: Findings From a Population-Based Cohort Study

OBJECTIVE

To determine the risk of cardiovascular disease (CVD), microvascular complications, and mortality in patients with type 2 diabetes who subsequently develop obstructive sleep apnea (OSA) compared with patients with type 2 diabetes without a diagnosis of OSA.

RESEARCH DESIGN AND METHODS

This age-, sex-, BMI-, and diabetes duration–matched cohort study used data from a U.K. primary care database from 1 January 2005 to 17 January 2018. Participants aged ≥16 years with type 2 diabetes were included. Exposed participants were those who developed OSA after their diabetes diagnosis; unexposed participants were those without diagnosed OSA. Outcomes were composite CVD (ischemic heart disease [IHD], stroke/transient ischemic attack [TIA], heart failure [HF]), peripheral vascular disease (PVD), atrial fibrillation (AF), peripheral neuropathy (PN), diabetes-related foot disease (DFD), referable retinopathy, chronic kidney disease (CKD), and all-cause mortality. The same outcomes were explored in patients with preexisting OSA before a diagnosis of type 2 diabetes versus diabetes without diagnosed OSA.

RESULTS

A total of 3,667 exposed participants and 10,450 matched control participants were included. Adjusted hazard ratios for the outcomes were as follows: composite CVD 1.54 (95% CI 1.32, 1.79), IHD 1.55 (1.26, 1.90), HF 1.67 (1.35, 2.06), stroke/TIA 1.57 (1.27, 1.94), PVD 1.10 (0.91, 1.32), AF 1.53 (1.28, 1.83), PN 1.32 (1.14, 1.51), DFD 1.42 (1.16, 1.74), referable retinopathy 0.99 (0.82, 1.21), CKD (stage 3–5) 1.18 (1.02, 1.36), albuminuria 1.11 (1.01, 1.22), and all-cause mortality 1.24 (1.10, 1.40). In the prevalent OSA cohort, the results were similar, but some associations were not observed.

CONCLUSIONS

Patients with type 2 diabetes who develop OSA are at increased risk of CVD, AF, PN, DFD, CKD, and all-cause mortality compared with patients without diagnosed OSA. Patients with type 2 diabetes who develop OSA are a high-risk population, and strategies to detect OSA and prevent cardiovascular and microvascular complications should be implemented.




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Acrylamide Exposure and Oxidative DNA Damage, Lipid Peroxidation, and Fasting Plasma Glucose Alteration: Association and Mediation Analyses in Chinese Urban Adults

OBJECTIVE

Acrylamide exposure from daily-consumed food has raised global concern. We aimed to assess the exposure-response relationships of internal acrylamide exposure with oxidative DNA damage, lipid peroxidation, and fasting plasma glucose (FPG) alteration and investigate the mediating role of oxidative DNA damage and lipid peroxidation in the association of internal acrylamide exposure with FPG.

RESEARCH DESIGN AND METHODS

FPG and urinary biomarkers of oxidative DNA damage (8-hydroxy-deoxyguanosine [8-OHdG]), lipid peroxidation (8-iso-prostaglandin-F2α [8-iso-PGF2α]), and acrylamide exposure (N-acetyl-S-[2-carbamoylethyl]-l-cysteine [AAMA], N-acetyl-S-[2-carbamoyl-2-hydroxyethyl]-l-cysteine [GAMA]) were measured for 3,270 general adults from the Wuhan-Zhuhai cohort. The associations of urinary acrylamide metabolites with 8-OHdG, 8-iso-PGF2α, and FPG were assessed by linear mixed models. The mediating roles of 8-OHdG and 8-iso-PGF2α were evaluated by mediation analysis.

RESULTS

We found significant linear positive dose-response relationships of urinary acrylamide metabolites with 8-OHdG, 8-iso-PGF2α, and FPG (except GAMA with FPG) and 8-iso-PGF2α with FPG. Each 1-unit increase in log-transformed level of AAMA, AAMA + GAMA (UAAM), or 8-iso-PGF2α was associated with a 0.17, 0.15, or 0.23 mmol/L increase in FPG, respectively (P and/or P trend < 0.05). Each 1% increase in AAMA, GAMA, or UAAM was associated with a 0.19%, 0.27%, or 0.22% increase in 8-OHdG, respectively, and a 0.40%, 0.48%, or 0.44% increase in 8-iso-PGF2α, respectively (P and P trend < 0.05). Increased 8-iso-PGF2α rather than 8-OHdG significantly mediated 64.29% and 76.92% of the AAMA- and UAAM-associated FPG increases, respectively.

CONCLUSIONS

Exposure of the general adult population to acrylamide was associated with FPG elevation, oxidative DNA damage, and lipid peroxidation, which in turn partly mediated acrylamide-associated FPG elevation.




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Dietary Manganese, Plasma Markers of Inflammation, and the Development of Type 2 Diabetes in Postmenopausal Women: Findings From the Womens Health Initiative

OBJECTIVE

To examine the association between manganese intake and the risk of type 2 diabetes in postmenopausal women and determine whether this association is mediated by circulating markers of inflammation.

RESEARCH DESIGN AND METHODS

We included 84,285 postmenopausal women without a history of diabetes from the national Women’s Health Initiative Observational Study (WHI-OS). Replication analysis was then conducted among 62,338 women who participated in the WHI-Clinical Trial (WHI-CT). Additionally, data from a case-control study of 3,749 women nested in the WHI-OS with information on biomarkers of inflammation and endothelial dysfunction were examined using mediation analysis to determine the relative contributions of these known biomarkers by which manganese affects type 2 diabetes risk.

RESULTS

Compared with the lowest quintile of energy-adjusted dietary manganese, WHI-OS participants in the highest quintile had a 30% lower risk of type 2 diabetes (hazard ratio [HR] 0.70 [95% CI 0.65, 0.76]). A consistent association was also confirmed in the WHI-CT (HR 0.79 [95% CI 0.73, 0.85]). In the nested case-control study, higher energy-adjusted dietary manganese was associated with lower circulating levels of inflammatory biomarkers that significantly mediated the association between dietary manganese and type 2 diabetes risk. Specifically, 19% and 12% of type 2 diabetes risk due to manganese were mediated through interleukin 6 and hs-CRP, respectively.

CONCLUSIONS

Higher intake of manganese was directly associated with a lower type 2 diabetes risk independent of known risk factors. This association may be partially mediated by inflammatory biomarkers.




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Using the BRAVO Risk Engine to Predict Cardiovascular Outcomes in Clinical Trials With Sodium-Glucose Transporter 2 Inhibitors

OBJECTIVE

This study evaluated the ability of the Building, Relating, Assessing, and Validating Outcomes (BRAVO) risk engine to accurately project cardiovascular outcomes in three major clinical trials—BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME), Canagliflozin Cardiovascular Assessment Study (CANVAS), and Dapagliflozin Effect on Cardiovascular Events–Thrombolysis in Myocardial Infarction (DECLARE-TIMI 58) trial—on sodium–glucose cotransporter 2 inhibitors (SGLT2is) to treat patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS

Baseline data from the publications of the three trials were obtained and entered into the BRAVO model to predict cardiovascular outcomes. Projected benefits of reducing risk factors of interest (A1C, systolic blood pressure [SBP], LDL, or BMI) on cardiovascular events were evaluated, and simulated outcomes were compared with those observed in each trial.

RESULTS

BRAVO achieved the best prediction accuracy when simulating outcomes of the CANVAS and DECLARE-TIMI 58 trials. For the EMPA-REG OUTCOME trial, a mild bias was observed (~20%) in the prediction of mortality and angina. The effect of risk reduction on outcomes in treatment versus placebo groups predicted by the BRAVO model strongly correlated with the observed effect of risk reduction on the trial outcomes as published. Finally, the BRAVO engine revealed that most of the clinical benefits associated with SGLT2i treatment are through A1C control, although reductions in SBP and BMI explain a proportion of the observed decline in cardiovascular events.

CONCLUSIONS

The BRAVO risk engine was effective in predicting the benefits of SGLT2is on cardiovascular health through improvements in commonly measured risk factors, including A1C, SBP, and BMI. Since these benefits are individually small, the use of the complex, dynamic BRAVO model is ideal to explain the cardiovascular outcome trial results.




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The Association of Energy and Macronutrient Intake at Dinner Versus Breakfast With Disease-Specific and All-Cause Mortality Among People With Diabetes: The U.S. National Health and Nutrition Examination Survey, 2003-2014

OBJECTIVE

This study aims to evaluate the association of energy and macronutrient intake at dinner versus breakfast with disease-specific and all-cause mortality in people with diabetes.

RESEARCH DESIGN AND METHODS

A total of 4,699 people with diabetes who enrolled in the National Health and Nutrition Examination Survey from 2003 to 2014 were recruited for this study. Energy and macronutrient intake was measured by a 24-h dietary recall. The differences () in energy and macronutrient intake between dinner and breakfast ( = dinner – breakfast) were categorized into quintiles. Death information was obtained from the National Death Index until 2015. Cox proportional hazards regression models were developed to evaluate the survival relationship between and diabetes, cardiovascular disease (CVD), and all-cause mortality.

RESULTS

Among the 4,699 participants, 913 deaths, including 269 deaths due to diabetes and 314 deaths due to CVD, were documented. After adjustment for potential confounders, compared with participants in the lowest quintile of in terms of total energy and protein, participants in the highest quintile were more likely to die due to diabetes (hazard ratio [HR]energy 1.92, 99% CI 1.08–3.42; HRprotein 1.92, 99% CI 1.06–3.49) and CVD (HRenergy 1.69, 99% CI 1.02–2.80; HRprotein 1.96, 99% CI 1.14–3.39). The highest quintile of total fat was related to CVD mortality (HR 1.67, 99% CI 1.01–2.76). Isocalorically replacing 5% of total energy at dinner with breakfast was associated with 4% and 5% lower risk of diabetes (HR 0.96, 95% CI 0.94–0.98) and CVD (HR 0.95, 95% CI 0.93–0.97) mortality, respectively.

CONCLUSIONS

Higher intake of energy, total fat, and protein from dinner than breakfast was associated with greater diabetes, CVD, and all-cause mortality in people with diabetes.




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microRNA-21/PDCD4 Proapoptotic Signaling From Circulating CD34+ Cells to Vascular Endothelial Cells: A Potential Contributor to Adverse Cardiovascular Outcomes in Patients With Critical Limb Ischemia

OBJECTIVE

In patients with type 2 diabetes (T2D) and critical limb ischemia (CLI), migration of circulating CD34+ cells predicted cardiovascular mortality at 18 months after revascularization. This study aimed to provide long-term validation and mechanistic understanding of the biomarker.

RESEARCH DESIGN AND METHODS

The association between CD34+ cell migration and cardiovascular mortality was reassessed at 6 years after revascularization. In a new series of T2D-CLI and control subjects, immuno-sorted bone marrow CD34+ cells were profiled for miRNA expression and assessed for apoptosis and angiogenesis activity. The differentially regulated miRNA-21 and its proapoptotic target, PDCD4, were titrated to verify their contribution in transferring damaging signals from CD34+ cells to endothelial cells.

RESULTS

Multivariable regression analysis confirmed that CD34+ cell migration forecasts long-term cardiovascular mortality. CD34+ cells from T2D-CLI patients were more apoptotic and less proangiogenic than control subjects and featured miRNA-21 downregulation, modulation of several long noncoding RNAs acting as miRNA-21 sponges, and upregulation of the miRNA-21 proapoptotic target PDCD4. Silencing miR-21 in control subject CD34+ cells phenocopied the T2D-CLI cell behavior. In coculture, T2D-CLI CD34+ cells imprinted naïve endothelial cells, increasing apoptosis, reducing network formation, and modulating the TUG1 sponge/miRNA-21/PDCD4 axis. Silencing PDCD4 or scavenging reactive oxygen species protected endothelial cells from the negative influence of T2D-CLI CD34+ cells.

CONCLUSIONS

Migration of CD34+ cells predicts long-term cardiovascular mortality in T2D-CLI patients. An altered paracrine signaling conveys antiangiogenic and proapoptotic features from CD34+ cells to the endothelium. This damaging interaction may increase the risk for life-threatening complications.




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The Influence of Baseline Diastolic Blood Pressure on the Effects of Intensive Blood Pressure Lowering on Cardiovascular Outcomes and All-Cause Mortality in Type 2 Diabetes

OBJECTIVE

To examine whether low baseline diastolic blood pressure (DBP) modifies the effects of intensive systolic blood pressure (SBP) lowering on cardiovascular outcomes in type 2 diabetes mellitus (T2DM).

RESEARCH DESIGN AND METHODS

The Action to Control Cardiovascular Risk in Diabetes Blood Pressure trial (ACCORD BP), a two-by-two factorial randomized controlled trial, examined effects of SBP (<120 vs. <140 mmHg) and glycemic (HbA1c <6% vs. 7.0–7.9% [<42 vs. 53–63 mmol/mol]) control on cardiovascular events in T2DM (N = 4,731). We examined whether effects of SBP control on cardiovascular composite were modified by baseline DBP and glycemic control.

RESULTS

Intensive SBP lowering decreased the risk of the cardiovascular composite (hazard ratio [HR] 0.76 [95% CI 0.59–0.98]) in the standard glycemic arm but not in the intensive glycemic arm (HR 1.06 [95% CI 0.81–1.40]). Spline regression models relating the effects of the intervention on the cardiovascular composite across the range of baseline DBP did not show evidence of effect modification by low baseline DBP for the cardiovascular composite in the standard or intensive glycemic arms. The relation between the effect of the intensive SBP intervention and baseline DBP was similar between glycemic arms for the cardiovascular composite three-way interaction (P = 0.83).

CONCLUSIONS

In persons with T2DM, intensive SBP lowering decreased the risk of cardiovascular composite end point irrespective of baseline DBP in the setting of standard glycemic control. Hence, low baseline DBP should not be an impediment to intensive SBP lowering in patients with T2DM treated with guidelines recommending standard glycemic control.




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Cardiovascular Risk Reduction With Liraglutide: An Exploratory Mediation Analysis of the LEADER Trial

OBJECTIVE

The LEADER trial (ClinicalTrials.gov reg. no. NCT01179048) demonstrated a reduced risk of cardiovascular (CV) events for patients with type 2 diabetes who received the glucagon-like peptide 1 receptor agonist liraglutide versus placebo. The mechanisms behind this CV benefit remain unclear. We aimed to identify potential mediators for the CV benefit observed with liraglutide in the LEADER trial.

RESEARCH DESIGN AND METHODS

We performed exploratory analyses to identify potential mediators of the effect of liraglutide on major adverse CV events (MACE; composite of CV death, nonfatal myocardial infarction, or nonfatal stroke) from the following candidates: glycated hemoglobin (HbA1c), body weight, urinary albumin-to-creatinine ratio (UACR), confirmed hypoglycemia, sulfonylurea use, insulin use, systolic blood pressure, and LDL cholesterol. These candidates were selected as CV risk factors on which liraglutide had an effect in LEADER such that a reduction in CV risk might result. We used two methods based on a Cox proportional hazards model and the new Vansteelandt method designed to use all available information from the mediator and to control for confounding factors.

RESULTS

Analyses using the Cox methods and Vansteelandt method indicated potential mediation by HbA1c (up to 41% and 83% mediation, respectively) and UACR (up to 29% and 33% mediation, respectively) on the effect of liraglutide on MACE. Mediation effects were small for other candidates.

CONCLUSIONS

These analyses identify HbA1c and, to a lesser extent, UACR as potential mediators of the CV effects of liraglutide. Whether either is a marker of an unmeasured factor or a true mediator remains a key question that invites further investigation.




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Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes

OBJECTIVE

To determine the effect of tirzepatide, a dual agonist of glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 receptors, on biomarkers of nonalcoholic steatohepatitis (NASH) and fibrosis in patients with type 2 diabetes mellitus (T2DM).

RESEARCH DESIGN AND METHODS

Patients with T2DM received either once weekly tirzepatide (1, 5, 10, or 15 mg), dulaglutide (1.5 mg), or placebo for 26 weeks. Changes from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST), keratin-18 (K-18), procollagen III (Pro-C3), and adiponectin were analyzed in a modified intention-to-treat population.

RESULTS

Significant (P < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks. Decreases with tirzepatide were significant compared with placebo for K-18 (10 mg) and Pro-C3 (15 mg) and with dulaglutide for ALT (10, 15 mg). Adiponectin significantly increased from baseline with tirzepatide compared with placebo (10, 15 mg).

CONCLUSIONS

In post hoc analyses, higher tirzepatide doses significantly decreased NASH-related biomarkers and increased adiponectin in patients with T2DM.




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Continuous Positive Airway Pressure Treatment, Glycemia, and Diabetes Risk in Obstructive Sleep Apnea and Comorbid Cardiovascular Disease

OBJECTIVE

Despite evidence of a relationship among obstructive sleep apnea (OSA), metabolic dysregulation, and diabetes, it is uncertain whether OSA treatment can improve metabolic parameters. We sought to determine effects of long-term continuous positive airway pressure (CPAP) treatment on glycemic control and diabetes risk in patients with cardiovascular disease (CVD) and OSA.

RESEARCH DESIGN AND METHODS

Blood, medical history, and personal data were collected in a substudy of 888 participants in the Sleep Apnea Cardiovascular End Points (SAVE) trial in which patients with OSA and stable CVD were randomized to receive CPAP plus usual care, or usual care alone. Serum glucose and glycated hemoglobin A1c (HbA1c) were measured at baseline, 6 months, and 2 and 4 years and incident diabetes diagnoses recorded.

RESULTS

Median follow-up was 4.3 years. In those with preexisting diabetes (n = 274), there was no significant difference between the CPAP and usual care groups in serum glucose, HbA1c, or antidiabetic medications during follow-up. There were also no significant between-group differences in participants with prediabetes (n = 452) or in new diagnoses of diabetes. Interaction testing suggested that women with diabetes did poorly in the usual care group, while their counterparts on CPAP therapy remained stable.

CONCLUSIONS

Among patients with established CVD and OSA, we found no evidence that CPAP therapy over several years affects glycemic control in those with diabetes or prediabetes or diabetes risk over standard-of-care treatment. The potential differential effect according to sex deserves further investigation.




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Circulating Retinol-Binding Protein 4 Is Inversely Associated With Pancreatic {beta}-Cell Function Across the Spectrum of Glycemia

OBJECTIVE

The aim of this study was to examine the association of circulating retinol-binding protein 4 (RBP4) levels with β-cell function across the spectrum of glucose tolerance from normal to overt type 2 diabetes.

RESEARCH DESIGN AND METHODS

A total of 291 subjects aged 35–60 years with normal glucose tolerance (NGT), newly diagnosed impaired fasting glucose or glucose tolerance (IFG/IGT), or type 2 diabetes were screened by a standard 2-h oral glucose tolerance test (OGTT) with the use of traditional measures to evaluate β-cell function. From these participants, 74 subjects were recruited for an oral minimal model test, and β-cell function was assessed with model-derived indices. Circulating RBP4 levels were measured by a commercially available ELISA kit.

RESULTS

Circulating RBP4 levels were significantly and inversely correlated with β-cell function indicated by the Stumvoll first-phase and second-phase insulin secretion indices, but not with HOMA of β-cell function, calculated from the 2-h OGTT in 291 subjects across the spectrum of glycemia. The inverse association was also observed in subjects involved in the oral minimal model test with β-cell function assessed by both direct measures and model-derived measures, after adjustment for potential confounders. Moreover, RBP4 emerged as an independent factor of the disposition index-total insulin secretion.

CONCLUSIONS

Circulating RBP4 levels are inversely and independently correlated with β-cell function across the spectrum of glycemia, providing another possible explanation of the linkage between RBP4 and the pathogenesis of type 2 diabetes.




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Classroom Observations

Classroom observations occur to document behaviors and to help provide insight to teachers. Teachers are teaching and are typically focused on the overall learning of the entire class. It is not possible for a teacher to catch all of the details of classroom while teaching. An outside observer, often a School Psychologist, can sit in the classroom and observe a student or the entire class. These insights can be used to help provide better instruction, create behavioral or academic interventions, or to document behaviors.

When do classroom observations occur?

- During a special education evaluation The classroom observation is a required component in a special education evaluation. It provides data and insight to the eligibility committee.

- Before a Behavior Intervention Plan or Functional Behavioral Assessment Classroom observations are important before implementing a Functional Behavioral Assessment or a Behavior Intervention Plan. It helps to clarify the current behaviors, identify possible triggers of the behavior, and determine the frequency of the behaviors.

- When a teacher is worried about a particular student Often a teacher will have a concern about a student and ask the School Psychologist to conduct an observation. After the observation the teacher and psychologist will meet to discuss and brainstorm strategies to assist in instruction.




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Promising New Research on Early Intervention for Autism

CNN reports that a study confirms that early autism intervention in toddlers is effective. A study was completed with a program called the Early Start Denver Model (ESDM). This program involves about twenty hours a week in the child's own home. It involves play and parents can easily learn some of the skills that can be applied in other settings. The study compared a group of toddlers that were given ESDM intervention to a group of toddlers receiving typical community interventions. Both groups showed improvement, but the ESDM group improved IQ by 18 points compared to 8 points with traditional interventions. The study is reporting that some of the children "virtually caught up to the typical kids their age." However, they are not claiming it is a cure for autism. According to the article they are working on a replication study to determine if there are similar results. Personally, I'm looking forward to the results of the replication study and want to find out more about this method. From what I understand it is less of a time constraint than ABA therapy.

This study also demonstrated the need for early intervention, which also includes early identification. When children are diagnosed early, they can begin receiving interventions that are proven effective. The study showed that current methods are working, but there may be a new program that can be even more effective on the horizon.

I'd love to hear more from my readers if you have any experience with ESDM or more information about it.




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New Poll: How Do You Feel About the Level Of Education The School Provides Your Child

I will be starting a monthly poll to engage the readers of this blog and start some discussion. Feel free to comment on this topic. I'm sure many of you have a lot to say. At the end of the month, I'll share and discuss results in a blog post. I'm curious to see how the readers of this blog feel about your own schools. You can find the poll in the sidebar. Thanks for participating!




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Assessing Bilingual Individuals

Two years into my position in a culturally diverse school system has taught me many things that I never would have learned in my previous position in a school system with much less diversity. I had hoped to be bilingual by now, but I’m not even close to that goal. However, I do have the training to conduct assessments with bilingual students. Thanks to Samuel Ortiz, Ph.D. for his workshops, research, and books that we use so much in our system. Thanks to the other Psychologists in my system for mentoring me and helping me learn this process. It has helped us to better identify which students have a disability and which students only look like they have a disability because of their performance on tests that are not standardized on children with different cultural and linguistic backgrounds. Learning a second language is not a disability. Just because a student is struggling academically, does not mean he should qualify for special education.

What everyone involved in school needs to know:
It takes many years for a person learning a language to develop academic use of language to the same level as monolingual individuals. It does not always seem that way when a person has excellent conversational skills in English. However, social use of language is not as sophisticated as academic use of language. Students can appear to be fluent, when in actuality the language and vocabulary is not on grade level. If a student’s comprehension and expression of language is below grade level, academics will naturally be below grade level as well. This is not the same as having a disabling condition.

A child with good social use of language, but developing academic use of language often looks to teachers like a student with a disability, when in reality the student may be a typically developing second language learner. Special education is not the answer for this student; the answer comes through hard work, patience, and instruction through a high quality English as a Second Language Program. In the past (and currently in many systems) this child would be misidentified as a student with a disability and inappropriately put into special education programs.

What Parents need to know:
Traditional assessments are not standardized for use with culturally and linguistically diverse students, so typical interpretation of scores on these assessments are inappropriate. When school systems try to use these assessments in the traditional way and then apply the unreliable scores into eligibility criteria, it’s frankly scary.

If you are a parent of an English Language learner, insist that a bilingual assessment be administered. I recognize that the irony of this statement is that many parents of bilingual students are not reading this blog as it is in English only. I don’t really have a good answer for that at this time.

What Teachers need to know:
If you are a teacher, recognize that academic language competency takes time and it requires additional assessment tools to tease out if the difficulties are primarily the result of language and cultural differences or if it is the result of a disability.

What School Psychologists need to know:
If you are a School Psychologist and not using the Cattell-Horn-Carroll Cross-Battery Assessment, I strongly encourage you to take a look. Here is an article from the National Association of School Psychologists Website by Samuel Ortiz, Ph.D. on resources for cultural competency. http://www.nasponline.org/resources/culturalcompetence/ortiz.pdf Advocate that all School Psychologists in your system be trained to administer bilingual assessments or at least have someone competent on hand for these assessments. You can’t hire a School Psychologist in every possible language you might need, so it only makes sense for all School Psychologists to be trained to assess all students. It takes more time to do the assessment, interpret data, and write a report and it requires the use of hiring an interpreter for portions of the assessment, but it is well worth the time and money to properly identify these students. If your school system does not see it this way, bring it up as a solution to disproportionality.




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Top 5 Questions about ADHD- From Everyday Health

Everyday Health is gathering the responses of several professionals of the top 5 questions they get regarding ADHD. They asked me to participate. The following are the questions and my answers. Check in with Everyday Health next week to see the compilation of responses.

1. Why are there so many theories about the causes of ADHD? What are the most common?

Any disorder that does not have a known cause is open to a number of theories. People naturally want to know why or want to feel as if it can be prevented in the future. Heredity is believed to be the most commonly accepted cause.

2. How can you explain the value of treatment to resistant parents? For example, “I survived my childhood with ADHD --and I was never diagnosed or treated. Why does my child need ADHD treatment?”

Often children with ADHD have gaps in their education. As they are in and out of focus each day, they miss key points in instruction. As new skills build upon old skills, it can be more and more difficult to learn new tasks where there are gaps in the foundation. This difficulty can make focusing even more difficult, further compounding the problem. Treatment can help reduce or prevent this cycle.

3. What role does a child’s school have in helping him or her with ADHD?

The school can help by providing support and accommodations specific to the particular needs of your child IF it can be determined that the symptoms of ADHD are significantly impacting his or her education. Of course, each school has different criteria for determining if there is a significant impact.

4. Are the medications recommended for ADHD safe for children? What are the potential dangers?

There is not a lot of solid research yet on this topic. While the medications are believed to be safe, they have not been around long enough to fully study long term effects. There are also side effects that may make the medications not worth the benefits in some children. All of that being said, I've seen kids who are finally able to focus after starting medication. Taking the medication improves learning, grades, and self esteem, which has numerous positive long term benefits. Medication is not something to take lightly. Parents must think very carefully weigh the unknown risks of taking the medications verses the possible risks of refusing the medications. There is not one answer that fits all children.

5. What are the most common side effects of ADHD meds?

Weight loss, behavioral changes, and headaches are possible side effects.




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Do I Have to Sign?

Parents are asked to sign paperwork when services begin, when changes are made, and if services end. Let's not stop there. Parents must sign before any assessments begin. Parents must sign that they attended meetings. Parents sign that they received a copy of special education rights. The reasoning is to protect everyone involved. It gives documentation to show who attended the meetings, shows parental consent for what is outlined in the plan, and documents what has occurred at the meeting.


Should I sign if I don't agree?
You do not have to sign what you do not agree with. That being said- if you attended the meeting, please sign where it says to sign that you attended the meeting. If you received paperwork, please sign that you received it. If you do not agree with the findings or do not agree with the services offered, then do not sign where it asks if you are in agreement. There may also be an area to sign that you do not agree with the findings and you may have an opportunity to write a dissenting opinion.

What will happen if I don't sign?
In general, the answer is nothing. Literally nothing will happen if you don't sign. Services can not begin until the parent signs. Changes can not take place until the parents sign. Services can not end (in most states) until the parent signs. In most cases if the parent refuses to sign, everything will remain basically the same. Laws vary between states on this issue, so make sure to check your own state laws.

Is it okay to think about it overnight before signing?
Absolutely. If you aren't sure, take some time to think things over or check in with an advocate. However, please do so in a timely manner, for the sake of everyone involved.

What if we do not come to an agreement?
There are times when parents and the school system do not agree. Usually, when all parties stop and listen to each other, an agreement can be made that is in the best interest of the child. Remember that schools have very strict guidelines that must be followed and there are restrictions to what a school can do.

Think about exactly what it is you disagree with. If you do not agree with the guidelines the school is following, then there is not much that can be done unless you are willing to go through an expensive and drawn out process in court that will still likely amount to no changes. In this case, it would be my best advice to work with the school to determine what can be done for your child within the guidelines.

If you disagree because you feel the school is not following state or federal guidelines, there are steps you can take. Start by discussing the area you feel is not being followed with the school or the special education administrator. Usually a resolution can be made by providing a second opinion at the cost of the school system or through the use of a mediator.

What is Erin's advice?
Try to reach an agreement, where you can feel comfortable signing as quickly as possible. You don't want to leave this open. If you need time to take it in to discuss it and then suggest some changes, that is within your right. However, I do not suggest refusing to sign for long periods of time. Those battles rarely end well for parents, the school, or the child.



  • IEP
  • Special Education Law

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Teacher's Role in a Successful Behavior Plan

Over the last few years I have been very busy working with teachers to create individualized behavior plans for several different elementary school students. There have been amazingly successful plans where some of the most significant behavior problems in the school have turned it around. Children who made daily trips to the office are only there now to receive praise from the administration. Teachers previously brought to tears from the behaviors have stopped me in the hall to say "Oh my goodness, he's like a different kid!" Students who were close to being sent to a day placement school are now succeeding in a regular classroom. It's very encouraging if I focus on those students. However, there have also been some plans that have been revised and revised and revised and the student is still struggling and the teacher is still severely frustrated. I have been reflecting on why some behavior plans work and others don't. Of course one of the biggest factors is the student. All students are different and the motivation for the misbehavior or lacking skill is different in each student. While this is important to consider, this particular article does not focus on this. I'm going to focus today on the teacher's role in making the behavior plan successful.




  • Focus on the Positive!!! The behavior plans that have had the most dramatic success are plans that allow the teacher to focus on the positive. Classroom consequences are still in place, but are not connected to the plan. Here is an example: Johnny's teachers will offer positive reinforcement frequently in the classroom by giving Johnny a “warm fuzzy” pom pom when he is caught engaging in a desired behavior. Johnny will chose the bag to keep the “warm fuzzies” in and carry the bag with him to every class. Once the bag is full, he receives an immediate reward. There is no limit to how many “warm fuzzies” he can earn in a day. He does not loose “warm fuzzies” that he has already earned. All teachers and staff who work with Johnny can give him “warm fuzzies” for his bag. This plan works because Johnny who was used to receiving a lot of negative feedback, is now getting positive attention frequently throughout the day. He receives something tangible (the warm fuzzy) that he can put into his bag. This begins to change his perception of himself, which changes his behavior, which changes his teacher's perception of him, which can potentially change his future. Plans that offer positive rewards completely separate from the classroom consequences seem to have the most significant effects.



  • Be Consistent. Teachers who are able to be consistent and are able to follow through every time have the most success with the plan. Oppositional children are excellent at pushing limits to see how far they can push. Consistent teachers have more success because they don't offer the wiggle room.



  • Be Flexible. This is not the opposite of being consistent. This is having flexibility in your expectations and stating them upfront. If the student was able to behave like everyone else in the class she would be. She may need some flexibility in some areas. For example you may need to have area for her to work in the classroom for times she needs to cool down and get away from a stimulus. The teacher may need to allow her extra time to finish projects if it is the transition that sets her off. Being flexible and willing to make acceptable changes for the student sets everyone up for success.



  • Remember that all students are different. The behaviors may be exactly the same as a student you had two years ago. However, that doesn't mean that the motivation for the behavior or the lacking skills are the same. What works for one student may not work for the next. That is the reason for the individualized plan. I strongly recommend doing a formal Functional Behavioral Assessment and a Behavior Intervention Plan.

Teachers have a HUGE part in making the Behavior Plan sucessful. It is the teacher who has to follow through and implement it consistently every day. It is the teacher who has to push forward even when it appears it isn't working at first. It is the teacher who has a tremendous positive impact on the student when the behavior starts turning around. It is the teacher who does the work to change lives!




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Why is My Child Defiant or Explosive?

Dedicated to the lady at Walmart with the screaming kid and all of us "good parents" who have been that lady at Walmart.

One of the most difficult behaviors for parents or teachers to address is explosive behavior, a child who has little control over emotions and "melts down" in the classroom or at home.  It is frustrating, it is embarrassing, it is anxiety producing, it causes intense emotions in ourselves.  Parents agonize over why it happens or what they did wrong?  Often the parents are blamed or judged by bystanders in stores, family members, friends, or school staff.  However, I have seen parents with a variety of parenting styles have kids with poor emotional control, including those who are strict, those who are quick to give in, those who spank, those who use time out, those who take away privileges, and a whole lot of parents who feel like they have tried everything.  I know children with very little emotional control from homes that are falling apart, from homes that are loving and supportive, from poor families, from affluent families, from parents who have no clue how to parent, from parents with excellent skills, even from School Psychologists.  This is not to say that parenting styles do not have a role in this, but there IS more to it.  We have to stop judging each other and get to the root of the problem.  

What is the Root of the Problem?

The problem, the reason some children "explode" or act out with little emotional control, is because he or she is lacking a skill.  Emotional control is a skill.  Most kids will learn this skill through consistent discipline strategies, but some do not. 

Another way to look at it.

We don't tell our kids how to read and then expect them to do it.  We show them step by step.  Some kids will pick it up easy, others will need to be taught and retaught and retaught and will need extensive help in doing so.  Do we blame ourselves?  Do we look at our friends judgementally and think to ourselves "look at the book she is using, it's all wrong?"  No, we assume the child has a problem learning to read and we find a way to teach him.  WE HAVE TO START LOOKING AT BEHAVIOR IN THE SAME WAY.  When a child is exploding, the first step should not be to label the child or blame the parent.  Lets start looking for the skill that is lacking.  When we find that skill, lets teach it.

It's NOT always a control issue.  Sometimes kids act out because they have not been taught to obey and respect authority, but sometimes they act out in spite of good training at home.  The explosions lead to self esteem problems in the child and the child feeling like a "bad kid," which in turn makes explosions bigger and more frequent.  Have you ever looked at a screaming child and demanded he control himself right now or "act your age."  It's a common thing to do.  Have you ever looked at a child with a Learning Disability and said "read on your grade level, now!" or "I have told you and told you how to read, why aren't you reading?"  Of course you haven't.  We work with the reader at his level and patiently try different strategies to improve reading.  We can't demand them to be good readers and we can't demand that a child who does not have the skills to control his emotions "act his age."  These explosive kids need skills and truth be told, we who work with these kids need skills. 

If you are a parent with a child who acts "out of control" stop blaming yourself.  It isn't necessarily because you spanked or didn't spank or were too strict or too lenient.  Your child is lacking the skills she needs to control her emotions.  Also, realize you are going to need to learn new skills to help your child learn the lacking skills.  You are no longer in the Parenting 101 class, you need to move on to the Advanced skill- teaching parenting class. 

The BEST book I have read on this topic is The Explosive Child by Ross Greene.  He addresses the skills these children might be lacking and he has great strategies to address the issue. (see Amazon link below)

If you are a teacher and have an "explosive child" in your class, rethink your perspective of the student.  The child needs to learn skills, so lets focus on teaching the skills and being patient with the children who are slower to learn emotional control.  We as school staff can not make excuses or blame the parents.  We have to reach the child at her level.  We teach a child to read at her level.  We must teach a child to control emotions at her level as well. 

Challenge for Everyone
Let us stop labeling these kids with emotional skill deficits as "bad kids" and stop judging the parents.  Let's be honest with ourselves and recognize we all have shortcomings and could use skills in certain areas.  Maybe our kids need skills in emotional control, maybe we do, maybe we need skills in teaching emotional control, or maybe we need skills in some other area all together.  Let's be patient with our children and our peers and ourselves. Let's stop criticizing ourselves and others and start learning and teaching new skills.   We don't live in a world with bad kids, we live in a world will kids who need skills, so let's teach.





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What Parents Need to Know About the Special Education Evaluation


I spend most days of my life working with various students who are at different parts in the sped referral process. I attend Child Study Meetings where we decide if we are going to evaluate a student. I observe and screen children and talk with parents and teachers to help the committee make a good decision about whether we should do a special education evaluation.   I evaluate those students (this includes Psychological testing, observations, talking with student/teacher/parent, doing rating scales, etc.). I attend eligibility meetings where we determine if the student is eligible for for special education services. All of this is second nature to me and sometimes I need to stop and remember when a parent comes in, that this is NEW.

When I talk to parents, I find that many parents do not fully understand the special education referral process, even when they nod and act like they do. We as school staff need to do a better job of helping the parents understand the process. Parents also need to speak up and ask questions when there is not understanding.

This is a guide for parents to understand the process of special education testing, the testing components, and some of the test data. It is important to note that schools systems and states will vary to some degree. If you have any questions about the process in your school system, ask your school psychologist, teacher, or principal. Parents have every right to ask questions and usually school personnel are happy to help make this process less anxiety-provoking for you. It is important for parents to understand their rights during the special education process.


Special Education Process

After data shows that interventions have been attempted and if a student is suspected of having a disability, a referral is made to evaluate him or her for special education testing. Once the parents sign the Permission for Testing Forms, timelines begin and the schools have 65 business days to complete the assessments and hold the eligibility meeting. Some states may have a different timeline.

During these 65 days, several testing components will be completed with you and your child. The evaluators will write reports and a copy will be given to parents at the eligibility meeting. However, schools are required to have a copy available for parents to pick up two days before the eligibility meeting. It is advised, that parents take advantage of this and read reports before the meeting to help get familiar with the information and to formulate questions. The reports hold a lot of information that can be overwhelming if you are not familiar with this type of testing. Read Understanding Test Scores to understand the types of tests used and what the scores mean.

Additionally, the meeting is likely to bring forth strong emotions as your child’s difficulties are discussed openly. It can be overwhelming for parents, especially when not prepared. When parents do not read the reports prior to the eligibility meeting, they are the only people at the table who come to the meeting not knowing what to expect.


What if My Child is Found ELIGIBLE for Special Education Services?

Once a child is eligible for special education services, the schools have 30 days to develop an Individualized Education Plan (IEP) for the student. This will consist of accommodations, goals, and describe the services offered. Parents are part of a committee to help create this document. Once it is signed, schools are legally required to follow it. It is reviewed once a year, unless parents or teachers feel that changes are necessary. Every three years, the committee will determine if the student should be reevaluated. This is called a triennial evaluation. Sometimes another full evaluation will be conducted, other times a review of records and updated teacher information is used.


What if My Child is Found INELIGIBLE for Special Education Services?

If your child was found ineligible for special education services and you agree with the eligibility findings, then your child will not receive special education. He or she was evaluated because of a problem that still needs to be addressed within regular education. Ask for a separate meeting with your teacher or a team to determine what accommodations or strategies can be used to help.

If you believe that your child requires special education services and has a disability, but was found ineligible for services, make an appointment to meet with the special education director. If an agreement cannot be reached, you may be able to have an Independent Evaluation at the expense of the school. The results of that testing will be brought back to an eligibility meeting. A child MUST have 2 things before they can receive special education services: They must have a disability and there must be a documented educational impact that the student requires special education services to be successful.






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The Blog is moving to School Psychologist Files

You can find all of the same articles in a more visually appealing Blog.  From now on use www.schoolpsychologistfiles.com/blog.  Thanks!




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Protecting the DREAM: The Potential Impact of Different Legislative Scenarios for Unauthorized Youth

With the Trump administration having announced the end of the DACA program, Congress is facing growing calls to protect unauthorized immigrants who came to the U.S. as children. This fact sheet examines DREAM Act bills introduced in Congress as of mid-2017, offering estimates of who might earn conditional legal status—and ultimately legal permanent residence—based on educational, professional, and other requirements in the legislation.




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The Diversity Visa Program Holds Lessons for Future Legal Immigration Reform

On paper, the Diversity Visa Program is not set up to bring in the highly skilled; applicants need only a high school diploma (or equivalent) or two years of mid-level work experience. Yet as this commentary explains, the green-card lottery has become a channel for entry of the highly skilled—with half of recipients coming to the United States in recent years having a college degree.




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Mexican Migration to Canada: Temporary Worker Programs, Visa Imposition, and NAFTA Shape Flows

Mexicans migrate to Canada in much smaller numbers than to the United States, yet over the last 30 years the country has become an increasingly attractive destination. Canada prioritizes highly skilled, educated Mexicans for permanent residency, but also attracts temporary workers from Mexico. This article examines Mexican migration to Canada and how it has been shaped by visa requirements, trade policy, and more.




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Federal judge declines to block COVID-19 abortion ban in Arkansas

A federal court on Thursday denied a motion to block an Arkansas directive preventing patients from receiving abortion care.




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Introducing wolves leads to fewer wildland coyotes, researchers find

As the population of gray wolves expands across the northern United States, researchers are finding a surprising side-effect: Their presence appears to lead to a reduction in the coyote population.




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House probe: Trump admin failed to adequately screen travelers from South Korea, Italy for COVID-19

The Trump administration failed to conduct effective screening of passengers from South Korea and Italy for the coronavirus when those countries were experiencing rapid expansion in COVID-19 cases.




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Pennsylvania, Texas, California among states lifting coronavirus restrictions Friday

California, Iowa, Pennsylvania and Rhode Island are among states that are loosening coronavirus restrictions Friday to gradually revive their economies.




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Supreme Court puts temporary block on release of evidence in Mueller probe

The Supreme Court on Friday granted a Justice Department request to temporarily block release of secret grand jury material from special counsel Robert Mueller's probe to Congress.




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U.S. copes with COVID-19 pandemic

The novel coronavirus, COVID-19, pandemic is spreading across the United States. People are discouraged (even banned in some places) from large gatherings, public spaces are closed, store shelves are empty, with long lines in grocery stores, and travel is limited. Here are some scenes from across America.




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Gujarat university, second MBBS examination, forensic medicine question papers, January 2015

Gujarat university, second MBBS examination, forensic medicine question papers, January 2015




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Gujarat university, second MBBS examination, microbiology question papers, January 2015

Gujarat university, second MBBS examination, microbiology question papers, January 2015




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Gujarat university, second MBBS examination, pathology question papers, January 2015

Gujarat university, second MBBS examination, pathology question papers, January 2015




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Gujarat university, second MBBS examination, pharmacology question papers (2010-2014)

Gujarat university, second MBBS examination, pharmacology question papers (2010-2014)




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Gujarat university, second MBBS examination, pharmacology question papers, January 2015

Gujarat university, second MBBS examination, pharmacology question papers, January 2015




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MD pharmacology examination, question papers, Gujarat university, April 2012

MD pharmacology examination, question papers, Gujarat university, April 2012




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MD pharmacology examination, question papers, Gujarat university, October 2012

MD pharmacology examination, question papers, Gujarat university, October 2012