b

Erratum. Predicting 10-Year Risk of End-Organ Complications of Type 2 Diabetes With and Without Metabolic Surgery: A Machine Learning Approach. Diabetes Care 2020;43:852-859




b

Clinical and Public Health Implications of 2019 Endocrine Society Guidelines for Diagnosis of Diabetes in Older Adults

OBJECTIVE

Screening for diabetes is typically done using hemoglobin A1c (HbA1c) or fasting plasma glucose (FPG). The 2019 Endocrine Society guidelines recommend further testing using an oral glucose tolerance test (OGTT) in older adults with prediabetic HbA1c or FPG. We evaluated the impact of this recommendation on diabetes prevalence, eligibility for glucose-lowering treatment, and estimated cost of implementation in a nationally representative sample.

RESEARCH DESIGN AND METHODS

We included 2,236 adults aged ≥65 years without known diabetes from the 2005–2016 National Health and Nutrition Examination Survey. Diabetes was defined using: 1) the Endocrine Society approach (HbA1c ≥6.5%, FPG ≥126 mg/dL, or 2-h plasma glucose ≥200 mg/dL among those with HbA1c 5.7–6.4% or FPG 100–125 mg/dL); and 2) a standard approach (HbA1c ≥6.5% or FPG ≥126 mg/dL). Treatment eligibility was defined using HbA1c cut points (≥7 to ≥9%). OGTT screening costs were estimated using Medicare fee schedules.

RESULTS

Diabetes prevalence was 15.7% (~5.0 million) using the Endocrine Society’s approach and 7.3% (~2.3 million) using the standard approach. Treatment eligibility ranged from 5.4 to 0.06% and 11.8–1.3% for diabetes cases identified through the Endocrine Society or standard approach, respectively. By definition, diabetes identified exclusively through the Endocrine Society approach had HbA11c <6.5% and would not be recommended for glucose-lowering treatment. Screening all older adults with prediabetic HbA1c/FPG (~18.3 million) with OGTT could cost between $737 million and $1.7 billion.

CONCLUSIONS

Adopting the 2019 Endocrine Society guidelines would substantially increase the number of older adults classified as having diabetes, require significant financial resources, but likely offer limited benefits.




b

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.




b

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.




b

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.




b

Metabolic Factors, Lifestyle Habits, and Possible Polyneuropathy in Early Type 2 Diabetes: A Nationwide Study of 5,249 Patients in the Danish Centre for Strategic Research in Type 2 Diabetes (DD2) Cohort

OBJECTIVE

To investigate the association of metabolic and lifestyle factors with possible diabetic polyneuropathy (DPN) and neuropathic pain in patients with early type 2 diabetes.

RESEARCH DESIGN AND METHODS

We thoroughly characterized 6,726 patients with recently diagnosed diabetes. After a median of 2.8 years, we sent a detailed questionnaire on neuropathy, including the Michigan Neuropathy Screening Instrument questionnaire (MNSIq), to identify possible DPN (score ≥4) and the Douleur Neuropathique en 4 Questions (DN4) questionnaire for possible associated neuropathic pain (MNSIq ≥4 + pain in both feet + DN4 score ≥3).

RESULTS

Among 5,249 patients with data on both DPN and pain, 17.9% (n = 938) had possible DPN, including 7.4% (n = 386) with possible neuropathic pain. In regression analyses, central obesity (waist circumference, waist-to-hip ratio, and waist-to-height ratio) was markedly associated with DPN. Other important metabolic factors associated with DPN included hypertriglyceridemia ≥1.7 mmol/L, adjusted prevalence ratio (aPR) 1.36 (95% CI 1.17; 1.59); decreased HDL cholesterol <1.0/1.2 mmol/L (male/female), aPR 1.35 (95% CI 1.12; 1.62); hs-CRP ≥3.0 mg/L, aPR 1.66 (95% CI 1.42; 1.94); C-peptide ≥1,550 pmol/L, aPR 1.72 (95% CI 1.43; 2.07); HbA1c ≥78 mmol/mol, aPR 1.42 (95% CI 1.06; 1.88); and antihypertensive drug use, aPR 1.34 (95% CI 1.16; 1.55). Smoking, aPR 1.50 (95% CI 1.24; 1.81), and lack of physical activity (0 vs. ≥3 days/week), aPR 1.61 (95% CI 1.39; 1.85), were also associated with DPN. Smoking, high alcohol intake, and failure to increase activity after diabetes diagnosis associated with neuropathic pain.

CONCLUSIONS

Possible DPN was associated with metabolic syndrome factors, insulin resistance, inflammation, and modifiable lifestyle habits in early type 2 diabetes.




b

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.




b

Microbiota-Related Metabolites and the Risk of Type 2 Diabetes

OBJECTIVE

Recent studies have highlighted the significance of the microbiome in human health and disease. Changes in the metabolites produced by microbiota have been implicated in several diseases. Our objective was to identify microbiome metabolites that are associated with type 2 diabetes.

RESEARCH DESIGN AND METHODS

5,181 participants from the cross-sectional Metabolic Syndrome in Men (METSIM) study that included Finnish men (age 57 ± 7 years, BMI 26.5 ± 3.5 kg/m2) having metabolomics data available were included in our study. Metabolomics analysis was performed based on fasting plasma samples. On the basis of an oral glucose tolerance test, Matsuda ISI and Disposition Index values were calculated as markers of insulin sensitivity and insulin secretion. A total of 4,851 participants had a 7.4-year follow-up visit, and 522 participants developed type 2 diabetes.

RESULTS

Creatine, 1-palmitoleoylglycerol (16:1), urate, 2-hydroxybutyrate/2-hydroxyisobutyrate, xanthine, xanthurenate, kynurenate, 3-(4-hydroxyphenyl)lactate, 1-oleoylglycerol (18:1), 1-myristoylglycerol (14:0), dimethylglycine, and 2-hydroxyhippurate (salicylurate) were significantly associated with an increased risk of type 2 diabetes. These metabolites were associated with decreased insulin secretion or insulin sensitivity or both. Among the metabolites that were associated with a decreased risk of type 2 diabetes, 1-linoleoylglycerophosphocholine (18:2) significantly reduced the risk of type 2 diabetes.

CONCLUSIONS

Several novel and previously reported microbial metabolites related to the gut microbiota were associated with an increased risk of incident type 2 diabetes, and they were also associated with decreased insulin secretion and insulin sensitivity. Microbial metabolites are important biomarkers for the risk of type 2 diabetes.




b

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.




b

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.




b

Adolescent Obesity and Early-Onset Type 2 Diabetes

OBJECTIVE

Type 2 diabetes (T2D) is increasingly diagnosed at younger ages. We investigated the association of adolescent obesity with incident T2D at early adulthood.

RESEARCH DESIGN AND METHODS

A nationwide, population-based study evaluated 1,462,362 adolescents (59% men, mean age 17.4 years) during 1996–2016. Data were linked to the Israeli National Diabetes Registry. Weight and height were measured at study entry. Cox proportional models were applied.

RESULTS

During 15,810,751 person-years, 2,177 people (69% men) developed T2D (mean age at diagnosis 27 years). There was an interaction among BMI, sex, and incident T2D (Pinteraction = 0.023). In a model adjusted for sociodemographic variables, the hazard ratios for diabetes diagnosis were 1.7 (95% CI 1.4–2.0), 2.8 (2.3–3.5), 5.8 (4.9–6.9), 13.4 (11.5–15.7), and 25.8 (21.0–31.6) among men in the 50th–74th percentile, 75th–84th percentile, overweight, mild obesity, and severe obesity groups, respectively, and 2.2 (1.6–2.9), 3.4 (2.5–4.6), 10.6 (8.3–13.6), 21.1 (16.0–27.8), and 44.7 (32.4–61.5), respectively, in women. An inverse graded relationship was observed between baseline BMI and mean age of T2D diagnosis: 27.8 and 25.9 years among men and women with severe obesity, respectively, and 29.5 and 28.5 years among low-normal BMI (5th–49th percentile; reference), respectively. The projected fractions of adult-onset T2D that were attributed to high BMI (≥85th percentile) at adolescence were 56.9% (53.8–59.9%) and 61.1% (56.8–65.2%) in men and women, respectively.

CONCLUSIONS

Severe obesity significantly increases the risk for incidence of T2D in early adulthood in both sexes. The rise in adolescent severe obesity is likely to increase diabetes incidence in young adults in coming decades.




b

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.




b

Screening and Treatment Outcomes in Adults and Children With Type 1 Diabetes and Asymptomatic Celiac Disease: The CD-DIET Study

OBJECTIVE

To describe celiac disease (CD) screening rates and glycemic outcomes of a gluten-free diet (GFD) in patients with type 1 diabetes who are asymptomatic for CD.

RESEARCH DESIGN AND METHODS

Asymptomatic patients (8–45 years) were screened for CD. Biopsy-confirmed CD participants were randomized to GFD or gluten-containing diet (GCD) to assess changes in HbA1c and continuous glucose monitoring over 12 months.

RESULTS

Adults had higher CD-seropositivity rates than children (6.8% [95% CI 4.9–8.2%, N = 1,298] vs. 4.7% [95% CI 3.4–5.9%, N = 1,089], P = 0.035) with lower rates of prior CD screening (6.9% vs. 44.2%, P < 0.0001). Fifty-one participants were randomized to a GFD (N = 27) or GCD (N = 24). No HbA1c differences were seen between the groups (+0.14%, 1.5 mmol/mol; 95% CI –0.79 to 1.08; P = 0.76), although greater postprandial glucose increases (4-h +1.5 mmol/L; 95% CI 0.4–2.7; P = 0.014) emerged with a GFD.

CONCLUSIONS

CD is frequently observed in asymptomatic patients with type 1 diabetes, and clinical vigilance is warranted with initiation of a GFD.




b

Early Metabolic Features of Genetic Liability to Type 2 Diabetes: Cohort Study With Repeated Metabolomics Across Early Life

OBJECTIVE

Type 2 diabetes develops for many years before diagnosis. We aimed to reveal early metabolic features characterizing liability to adult disease by examining genetic liability to adult type 2 diabetes in relation to metabolomic traits across early life.

RESEARCH DESIGN AND METHODS

Up to 4,761 offspring from the Avon Longitudinal Study of Parents and Children were studied. Linear models were used to examine effects of a genetic risk score (162 variants) for adult type 2 diabetes on 229 metabolomic traits (lipoprotein subclass–specific cholesterol and triglycerides, amino acids, glycoprotein acetyls, others) measured at age 8 years, 16 years, 18 years, and 25 years. Two-sample Mendelian randomization (MR) was also conducted using genome-wide association study data on metabolomic traits in an independent sample of 24,925 adults.

RESULTS

At age 8 years, associations were most evident for type 2 diabetes liability (per SD-higher) with lower lipids in HDL subtypes (e.g., –0.03 SD, 95% CI –0.06, –0.003 for total lipids in very large HDL). At 16 years, associations were stronger with preglycemic traits, including citrate and with glycoprotein acetyls (0.05 SD, 95% CI 0.01, 0.08), and at 18 years, associations were stronger with branched chain amino acids. At 25 years, associations had strengthened with VLDL lipids and remained consistent with previously altered traits, including HDL lipids. Two-sample MR estimates among adults indicated persistent patterns of effect of disease liability.

CONCLUSIONS

Our results support perturbed HDL lipid metabolism as one of the earliest features of type 2 diabetes liability, alongside higher branched-chain amino acid and inflammatory levels. Several features are apparent in childhood as early as age 8 years, decades before the clinical onset of disease.




b

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.




b

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.




b

Strict Preanalytical Oral Glucose Tolerance Test Blood Sample Handling Is Essential for Diagnosing Gestational Diabetes Mellitus

OBJECTIVE

Preanalytical processing of blood samples can affect plasma glucose measurement because on-going glycolysis by cells prior to centrifugation can lower its concentration. In June 2017, ACT Pathology changed the processing of oral glucose tolerance test (OGTT) blood samples for pregnant women from a delayed to an early centrifugation protocol. The effect of this change on the rate of gestational diabetes mellitus (GDM) diagnosis was determined.

RESEARCH DESIGN AND METHODS

All pregnant women in the Australian Capital Territory (ACT) are recommended for GDM testing with a 75-g OGTT using the World Health Organization diagnostic criteria. From January 2015 to May 2017, OGTT samples were collected into sodium fluoride (NaF) tubes and kept at room temperature until completion of the test (delayed centrifugation). From June 2017 to October 2018, OGTT samples in NaF tubes were centrifuged within 10 min (early centrifugation).

RESULTS

A total of 7,509 women were tested with the delayed centrifugation protocol and 4,808 with the early centrifugation protocol. The mean glucose concentrations for the fasting, 1-h and 2-h OGTT samples were, respectively, 0.24 mmol/L (5.4%), 0.34 mmol/L (4.9%), and 0.16 mmol/L (2.3%) higher using the early centrifugation protocol (P < 0.0001 for all), increasing the GDM diagnosis rate from 11.6% (n = 869/7,509) to 20.6% (n = 1,007/4,887).

CONCLUSIONS

The findings of this study highlight the critical importance of the preanalytical processing protocol of OGTT blood samples used for diagnosing GDM. Delay in centrifuging of blood collected into NaF tubes will result in substantially lower rates of diagnosis than if blood is centrifuged early.




b

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.




b

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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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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A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial

OBJECTIVE

The role of U300 glargine insulin for the inpatient management of type 2 diabetes (T2D) has not been determined. We compared the safety and efficacy of glargine U300 versus glargine U100 in noncritically ill patients with T2D.

RESEARCH DESIGN AND METHODS

This prospective, open-label, randomized clinical trial included 176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA1c 9.5 ± 2.2%), treated with oral agents or insulin before admission. Patients were treated with a basal-bolus regimen with glargine U300 (n = 92) or glargine U100 (n = 84) and glulisine before meals. We adjusted insulin daily to a target BG of 70–180 mg/dL. The primary end point was noninferiority in the mean difference in daily BG between groups. The major safety outcome was the occurrence of hypoglycemia.

RESULTS

There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70–180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74). There were no differences in the proportion of patients with BG <70 mg/dL (8.7% vs. 9.5%, P > 0.99), but glargine U300 resulted in significantly lower rates of clinically significant hypoglycemia (<54 mg/dL) compared with glargine U100 (0% vs. 6.0%, P = 0.023).

CONCLUSIONS

Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.




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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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Instability of Insulin Aspart Diluted in Dextrose




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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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The Unpopular Realities of the Eligibility

The eligibility criteria for special education services is black and white. (I'm not talking about the color of skin.) Either the student fits the criteria or does not fit the criteria. The committee comes together with all the test data and then reviews the criteria for each disability. Either the student is eligible or not. They meet the criteria or they do not meet the criteria. Sounds easy, right? The kids who obviously fit the criteria easily qualify for special education services. The kids who clearly do not fit criteria for special education do not qualify for special education services. It should just be that easy. Sometimes it is.

I've been in the field long enough to see that eligibility is not always this magical process that determines special education from regular education. Sometimes eligibility decisions are a nightmare. What about all the gray kids that aren't clearly black or white?! For some kids, determining if they meet the criteria is tough. The black and white criteria makes it difficult to know what to do for the gray kids. The most difficult eligibility meetings are the ones where some members feel the student meets criteria and other members do not. These can lead to heated discussions. There are sometimes different ways to look at data and opinions of how to look at it may vary. Remember that the real issue the student who is cared about by school staff and especially parents which makes the decision emotional. It can be hard to be objective at times. It is not uncommon to hear "but they need it," even when the data does not support it.

There are kids who qualify for special education services at one point, then are found ineligible at another time. Sometimes this happens because the student has made improvements and no longer requires special education services to be successful. Other times this happens because criteria has changed, the criteria is slightly different in a new different school system, or because test data is slightly different after a few years. In my opinion, this is when the system and criteria fails. I'd like to see ways to address the students who at one time fit the criteria, no longer fit criteria, but still require services.

Why is the criteria so rigid? The main reason is because special education is funded by the government and they keep a tight reign on eligibility criteria. School staff is pressured by the administration, who is pressured by the State, who is pressured by the Federal government. There is a call for identification to be accurate to ensure that funds are properly spent. The only way the government can determine if the funds are being used appropriately is to enforce that schools are using clear criteria guidelines for identification.

All that being said, I believe in the process (for the most part). However, it's created by humans meaning there will be errors. If I had a say, I'd make some changes. I do believe there needs to be criteria. No matter who sets the criteria there will always be those gray kids that are just right on the border of eligible or not eligible. The worst mistake that can be made in my opinion is telling a family that the child has a disability when in fact the child does not. The child grows up with the belief that he or she has a disabling condition, when that could have been prevented. Disability identification can be life changing for a person. That is why I believe we need criteria. A strong opinion by a teacher or parent that "she needs it" is not enough data for me to look a child and say they are struggling because of a disability.

Want to learn more about the eligibility process?
Eligibility Process FAQ
What every parent needs to know about the referral process
Ineligible for special education




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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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Readers Respond About Your Own Experiences In the Schools

The readers of School Psychologist Blog Files were asked in February to share their own experiences and to vote on a poll "How do you feel about the level of education the school provides your child." It's important to understand that everyone's experience is unique. The readers come from different states, different school systems, and different grade levels. Laws and standards vary somewhat between states. Within any state, there are schools that do a better job suiting the needs of children than others. Within any school system, there are those star schools, and the schools that need more attention. Even within the best schools, there are still going to be individuals who have negative experiences. Within the worst schools, there will be those who have positive experiences. Regardless of your school or your situation, I believe that the readers of this blog care deeply about their child's education and have strong emotions about the education (positive or negative.)

The most popular response was "I generally feel good about the level of education, but have some complaints." I was glad to see that many of you are mostly satisfied. I hope that continues throughout your children's school career. Stay involved, speak up when needed, and compliment those who deserve it.

There was a strong outcry from those who endorsed "I feel as if the school is not supportive and I feel as though I am constantly fighting for his or her rights." This was the second most popular answer. While many feel comfortable with their schools, there are many parents out there who have the unsettling feeling of sending their child to a place they do not feel good about. Many of the readers are feeling that getting appropriate services only comes with a fight. Some of you are not having good experiences. I hope that you are able to find some support and insight here from others.

A few of you feel very thankful for the high level of education that your child is receiving. I am thankful to hear that some of the parents here feel exceptionally good about their child's school. Know this is a blessing that many others do not have.

Feel free to share your comments about experiences and offer some insight to others who may have similar experiences.




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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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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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Did you like our Facebook Page?

Stay connected with School Psychologist Files by joining the School Psychologist Files Facebook Page.  You can be one of the first to know about new articles on the School Psychologist Files website such as the brand new FAQ Parents ask about the IEP that I finished this weekend. 




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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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Check out this Awesome Special Education Infographic by USC Rossier





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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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Is U.S.-Mexico Cooperation on Migration Possible?

As the numbers of Central American migrants crossing into Mexico and the United States rises—putting migration front and center in the U.S.-Mexico relationship again—this event examines the opportunities for cooperation between the two countries, along with ways to improve U.S. and Mexican asylum systems, create new approaches to labor migration, address smuggling networks, and modernize border management.




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&quot;Merit-Based&quot; Immigration: Designing Successful Selection Systems

With the U.S. administration calling for the United States to adopt a more “merit-based” immigrant selection system, this conversation focused on what policymakers should consider in designing—and managing—immigrant selection systems in a time of intense labor-market and demographic change.




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Differing DREAMs: Estimating the Unauthorized Populations That Could Benefit under Different Legalization Bills

2017 saw the introduction of several bills—two of them by Senate Republicans in the weeks following the Trump administration’s announcement that it would terminate the Deferred Action for Childhood Arrivals (DACA) program—that would provide a pathway to conditional and then legal permanent residence to unauthorized immigrants brought to the United States as children, if they meet a range of educational, professional, and other criteria.




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A Profile of Current DACA Recipients by Education, Industry, and Occupation

An average of 915 DACA recipients every day will lose their work authorization and protection from deportation once the phaseout of the program moves into full force in spring 2018, MPI estimates. This fact sheet also offers U.S. and state estimates of the school enrollment and educational attainment, workforce participation, and industries and occupations of employment for the nearly 690,000 current DACA holders.




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Mainstreaming 2.0: How Europe’s Education Systems Can Boost Migrant Inclusion

Rising numbers of young immigrants and refugees entering European schools following the 2015–16 migration crisis strained system capacity and injected new urgency into debates about how to support diverse learners and their families. This report examines the challenges facing European education systems and identifies key lessons to improve migrant inclusion in schools and integration more broadly.




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Preparing Newcomers for the Jobs of Today and the Labor Markets of Tomorrow

This Migration Policy Institute Europe webinar examines possible scenarios for how social, economic, and technological trends could affect jobs, labor market policy, education and social policies, and migrant integration. Speakers also explored the potential of coding schools for refugees to help alleviate skills shortages and provide a pathway to work.




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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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Police arrest two men in shooting death of Ahmaud Arbery

More than two months after Ahmaud Arbery was fatally shot while jogging near Brunswick, Georgia police arrested two men for the shooting, authorities said.




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UPI News Quiz: Asian baseball, Grimes' baby, scary insects

Asian baseball, Grimes' baby, scary invasive insects -- how well did you follow the news this week? Take the UPI News Quiz for May 8, 2020.




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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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Labor Dept.: U.S. economy lost 20.5M jobs in April, unemployment near 15%

The United States economy shed more than 20 million jobs last month, the greatest month-to-month decline in history, the Labor Department said Friday in its monthly employment analysis.




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DNA genealogy leads police to James E. Zastawnik in 1987 killing of Ohio teen Barbara Blatnik

Cleveland police say they have used DNA research to solve the 33-year-old strangling of a teenage girl, and arrest her killer.




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

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