The obesity paradox: Retinopathy, obesity, and circulating risk markers in youth with type 2 diabetes in the TODAY Study.

AIM: To understand the relationship of obesity and 27 circulating inflammatory biomarkers to the prevalence of non-proliferative diabetic retinopathy (NPDR) in youth with type 2 diabetes. METHODS: Youth with type 2 diabetes who participated in the TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study were followed for 2-6.5 years. Digital fundus photographs were obtained in the last year of the study. Blood samples during the study were processed for inflammatory biomarkers, and these were correlated with obesity tertiles and presence of retinopathy. RESULTS: Higher BMI was associated with an increase in circulating levels of metabolic biomarkers including high sensitivity C-reactive protein (hsCRP), plasminogen activator inhibitor 1 (PAI-1), fibrinogen, LDL-cholesterol (LDL-C) and Apolipoprotein B (ApoB), tumor necrosis factor receptors 1 and 2 (TNFR-1 and -2), interleukin 6 (IL-6), E-selectin, and homocysteine, as well as a decrease in the metabolic risk markers HDL-cholesterol (HDLC), and insulin-like growth factor binding protein 1 (IGFBP-1). Although NPDR risk decreased with increasing obesity, it was not associated with any of the measured biomarkers. CONCLUSIONS: Circulating levels of measured biomarkers did not elucidate the "obesity paradox" of decreased NPDR in the most obese participants in the TODAY study. TRIAL REGISTRATION: clinicaltrials.govNCT00081328.

The association between depression symptom endorsement and glycemic outcomes in adolescents with type 1 diabetes.

OBJECTIVE: The prevalence of depression among adolescents with type 1 diabetes is estimated to be 2-3 times higher than in the general population. In adults with type 1 diabetes and depression, short-term outcomes are worse compared to individuals just diagnosed with type 1 diabetes. This study aims to determine if depressive symptom endorsement is associated with glycemic outcomes and short-term complications in adolescents with type 1 diabetes. RESEARCH DESIGN AND METHODS: Analysis was conducted using electronic medical records from the T1D Exchange Quality Improvement Collaborative. Adolescents with type 1 diabetes, aged 12-18, receiving treatment in a diabetes clinic who had been screened for depression with the PHQ-9 between 2016 and 2018 were eligible for inclusion. Individuals must have also had HbA1c data available from the day of depression screening and from 10 to 24 weeks after screening; the final sample size was 1714. RESULTS: Almost 30% of adolescents endorsed mild or greater (PHQ-9 ≥ 5) depressive symptoms. Endorsement of mild or greater depressive symptoms was associated with an 18% increased risk of an HbA1c ≥7.5% and a 42% increased risk of an HbA1c ≥9.0% on the day of screener administration. Depressive symptom endorsement was also associated with an 82% increased risk for DKA. CONCLUSIONS: This study suggests that depression symptoms are associated with an increased risk for elevated HbA1c and short-term complications. With the rising incidence of type 1 diabetes in youth, routine screening, and appropriate management of depression is needed.

Serum Urate Lowering with Allopurinol and Kidney Function in Type 1 Diabetes.

BACKGROUND: Higher serum urate levels are associated with an increased risk of diabetic kidney disease. Lowering of the serum urate level with allopurinol may slow the decrease in the glomerular filtration rate (GFR) in persons with type 1 diabetes and early-to-moderate diabetic kidney disease. METHODS: In a double-blind trial, we randomly assigned participants with type 1 diabetes, a serum urate level of at least 4.5 mg per deciliter, an estimated GFR of 40.0 to 99.9 ml per minute per 1.73 m2 of body-surface area, and evidence of diabetic kidney disease to receive allopurinol or placebo. The primary outcome was the baseline-adjusted GFR, as measured with iohexol, after 3 years plus a 2-month washout period. Secondary outcomes included the decrease in the iohexol-based GFR per year and the urinary albumin excretion rate after washout. Safety was also assessed. RESULTS: A total of 267 patients were assigned to receive allopurinol and 263 to receive placebo. The mean age was 51.1 years, the mean duration of diabetes 34.6 years, and the mean glycated hemoglobin level 8.2%. The mean baseline iohexol-based GFR was 68.7 ml per minute per 1.73 m2 in the allopurinol group and 67.3 ml per minute per 1.73 m2 in the placebo group. During the intervention period, the mean serum urate level decreased from 6.1 to 3.9 mg per deciliter with allopurinol and remained at 6.1 mg per deciliter with placebo. After washout, the between-group difference in the mean iohexol-based GFR was 0.001 ml per minute per 1.73 m2 (95% confidence interval [CI], -1.9 to 1.9; P = 0.99). The mean decrease in the iohexol-based GFR was -3.0 ml per minute per 1.73 m2 per year with allopurinol and -2.5 ml per minute per 1.73 m2 per year with placebo (between-group difference, -0.6 ml per minute per 1.73 m2 per year; 95% CI, -1.5 to 0.4). The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo. The frequency of serious adverse events was similar in the two groups. CONCLUSIONS: We found no evidence of clinically meaningful benefits of serum urate reduction with allopurinol on kidney outcomes among patients with type 1 diabetes and early-to-moderate diabetic kidney disease. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; PERL ClinicalTrials.gov number, NCT02017171.).

Barriers to Weight Loss and Physical Activity, and Coach Approaches to Addressing Barriers, in a Real-World Adaptation of the DPP Lifestyle Intervention: A Process Analysis.

PURPOSE: The purpose of this study is to identify barriers to weight loss and physical activity, as well as approaches used by coaches, in a real-world, community sample of adults with metabolic syndrome (at risk for type 2 diabetes) who participated in a Diabetes Prevention Program (DPP)-adapted weight loss intervention and compare findings to data from the screened and highly selected DPP sample. METHODS: SHINE (Support, Health Information, Nutrition, and Exercise) was a telephonic DPP adaptation. Primary care staff delivered the DPP curriculum, and lifestyle coaches provided monthly direction to achieve weight loss. For this substudy, barriers to weight loss and physical activity described by participants, as well as approaches coaches used to address them, were gathered. Groupings of barriers (DPP defined) were analyzed in relation to demographic characteristics and compared to data from the DPP sample. RESULTS: Top weight loss barriers were problems with self-monitoring, too little physical activity, internal thought/mood cues, vacation/holidays, and social cues. Percentages reporting a barrier were much higher in SHINE. Top physical activity barriers were problems with self-monitoring, access/weather, time management, aches/pains, and vacation/holidays. These did not correspond closely to DPP data. Coaches used problem solving, self-monitoring skills review, increased physical activity, and motivational strategies. SHINE coaches were more likely than DPP coaches to use alternative approaches. CONCLUSIONS: Barriers to weight loss and physical activity in a community sample of persons at risk for diabetes occurred at much higher rates than in the highly screened DPP sample. Training coaches in a variety of patient-centered approaches may maximize their positive impact.

Preventing Early Renal Loss in Diabetes (PERL) Study: A Randomized Double-Blinded Trial of Allopurinol-Rationale, Design, and Baseline Data.

OBJECTIVE: Higher serum uric acid (SUA) is associated with diabetic kidney disease (DKD). Preventing Early Renal Loss in Diabetes (PERL) evaluates whether lowering SUA with allopurinol slows glomerular filtration rate (GFR) loss in people with type 1 diabetes (T1D) and mild to moderate DKD. We present the PERL rationale, design, and baseline characteristics. RESEARCH DESIGN AND METHODS: This double-blind, placebo-controlled, multicenter trial randomized 530 participants with T1D, estimated GFR (eGFR) of 40-99.9 mL/min/1.73 m2, SUA ≥4.5 m/dL, and micro- to macroalbuminuric DKD or normoalbuminuria with declining kidney function (NDKF) (defined as historical eGFR decline ≥3 mL/min/1.73 m2/year) to allopurinol or placebo. The primary outcome is baseline-adjusted iohexol GFR (iGFR) after 3 years of treatment plus a 2-month washout period. RESULTS: Participants are 66% male and 84% white. At baseline, median age was 52 years and diabetes duration was 35 years, 93% of participants had hypertension, and 90% were treated with renin-angiotensin system inhibitors (median blood pressure 127/71 mmHg). Median HbA1c was 8%, SUA 5.9 mg/dL, iGFR 68 mL/min/1.73 m2, and historical eGFR slope -3.5 mL/min/1.73 m2/year. Compared with participants with albuminuria (n = 419), those with NDKF (n = 94) were significantly older (56 vs. 52 years), had lower HbA1c (7.7 vs. 8.1%) and SUA (5.4 vs. 6.0 mg/dL), and had higher eGFR (82 vs. 74 mL/min/1.73 m2) and historical eGFR loss (-4.7 vs. -2.5 mL/min/1.73 m2/year). These differences persisted when comparing groups with similar rates of historical eGFR loss. CONCLUSIONS: PERL will determine the effect of allopurinol on mild to moderate DKD in T1D, with or without albuminuria. Participants with normoalbuminuria and rapid GFR loss manifested many DKD risk factors of those with albuminuria, but with less severity.

Elevated Serum Uric Acid Is Associated With Greater Risk for Hypertension and Diabetic Kidney Diseases in Obese Adolescents With Type 2 Diabetes: An Observational Analysis From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study.

OBJECTIVE: Elevated serum uric acid (SUA) is increasingly recognized as a risk factor for kidney disease in adults with diabetes, but data in youth are limited. We hypothesized that elevated SUA predicts development of elevated urinary albumin excretion (UAE) and hypertension over time in teens with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: Serum creatinine, cystatin C, SUA, and the urine albumin-to-creatinine ratio (UACR) were assessed in 539 obese youth, ages 12-17 years, with T2D duration <2 years at baseline in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study. Estimated glomerular filtration rate (eGFR) was calculated using creatinine and cystatin C. Hypertension was defined as systolic or diastolic blood pressure ≥130/80 mmHg and elevated UAE as UACR ≥30 mg/g. Cox proportional hazards models evaluated the relationship between SUA and outcome variables longitudinally over an average follow-up of 5.7 years, adjusting for age, sex, race/ethnicity, BMI, HbA1c, eGFR, ACE inhibitor/angiotensin receptor blocker use, and TODAY treatment group assignment. RESULTS: At baseline, hyperuricemia (≥6.8 mg/dL) was present in 25.6% of participants, hypertension in 18.7%, and elevated UAE in 6.1%. During follow-up of up to 7 years, hypertension developed in 37.4% and UAE in 18.0%. Higher baseline SUA increased the risk of incident hypertension (hazard ratio [HR] 1.19, 95% CI 1.03-1.38, per 1 mg/dL increase in SUA) and elevated UAE (HR 1.24, 95% CI 1.03-1.48) in adjusted models. CONCLUSIONS: Hyperuricemia was common in youth with T2D. Higher baseline SUA independently increased the risk for onset of hypertension and elevated UAE. Research is needed to determine whether SUA-lowering therapies can impede development of diabetic kidney disease and hypertension in T2D youth.

Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study.

OBJECTIVES: To examine cardiac biomarkers over time in youth-onset type 2 diabetes, and relate serum concentrations to cardiovascular disease risk factors, and left ventricular structure and function. STUDY DESIGN: TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) was a multicenter randomized trial of 3 treatments including 521 participants with type 2 diabetes, aged 10-17 years, and with 2-6 years of follow-up. Participants were 36% male, obese, and ethnically diverse. Annual serum concentrations of brain natriuretic peptide, troponin, tumor necrosis factor (TNF)-α, receptors 1 and 2 were related to blood pressure, body mass index, hemoglobin A1c, and left ventricular ejection fraction, diastolic function, relative wall thickness, and mass. RESULTS: Elevated concentrations of brain natriuretic peptide (≥100 pg/mL), TNF-α (≥5.6 pg/mL) and troponin (≥0.01 ng/mL), were present in 17.8%, 18.3%, and 34.2% of the cohort, respectively, at baseline, and in 15.4%, 17.1%, and 31.1% at the end of the study, with wide variability over time, without persistence in individuals or clear relationship to glycemia or cardiovascular structure/function. TNF receptors concentrations were increased at baseline and not significantly different from end-of-study concentrations. Adverse echocardiographic measures were more likely in the highest TNF receptor tertile (all P < .05): higher left ventricular mass (39.3 ± 9.0 g/m2.7), left atrial internal dimension (3.7 ± 0.4 cm) and E/Em ratio, a measure of diastolic dysfunction (6.2 ± 1.9). After adjustment for body mass index, these relationships were no longer significant. CONCLUSIONS: Elevated serum concentrations of cardiac biomarkers were common in youth with type 2 diabetes, but their clinical significance is unclear and will require further long-term study. TRIAL REGISTRATION: ClinicalTrials.govNCT00081328.

Metabolic syndrome is associated with exposure to organochlorine pesticides in Anniston, AL, United States.

The Anniston Community Health Survey, a cross-sectional study, was undertaken in 2005-2007 to study environmental exposure to polychlorinated biphenyl (PCB) and organochlorine (OC) pesticides and health outcomes among residents of Anniston, AL, United States. The examination of potential risks between these pollutants and metabolic syndrome, a cluster of cardiovascular risk factors (i.e., hypertension, central obesity, dyslipidemia and dysglycemia) was the focus of this analysis. Participants were 548 adults who completed the survey and a clinic visit, were free of diabetes, and had a serum sample for clinical laboratory parameters as well as PCB and OC pesticide concentrations. Associations between summed concentrations of 35 PCB congeners and 9 individual pesticides and metabolic syndrome were examined using generalized linear modeling and logistic regression; odds ratios (OR) and 95% confidence intervals (CI) are reported. Pollutants were evaluated as quintiles and as log transformations of continuous serum concentrations. Participants were mostly female (68%) with a mean age (SD) of 53.6 (16.2) years. The racial distribution was 56% white and 44% African American; 49% met the criteria for metabolic syndrome. In unadjusted logistic regression, statistically significant and positive associations across the majority of quintiles were noted for seven individually modeled pesticides (p,p'-DDT, p,p'-DDE, HCB, ß-HCCH, oxychlor, tNONA, Mirex). Following adjustment for covariables (i.e., age, sex, race, education, marital status, current smoking, alcohol consumption, positive family history of diabetes or cardiovascular disease, liver disease, BMI), significant elevations in risk were noted for p,p'-DDT across multiple quintiles (range of ORs 1.61 to 2.36), for tNONA (range of ORs 1.62-2.80) and for p,p'-DDE [OR (95% CI)] of 2.73 (1.09-6.88) in the highest quintile relative to the first. Significant trends were observed in adjusted logistic models for log10 HCB [OR=6.15 (1.66-22.88)], log10 oxychlor [OR=2.09 (1.07-4.07)] and log10 tNONA [3.19 (1.45-7.00)]. Summed PCB concentrations were significantly and positively associated with metabolic syndrome only in unadjusted models; adjustment resulted in attenuation of the ORs in both the quintile and log-transformed models. In conclusion, several OC pesticides were found to have significant associations with metabolic syndrome in the Anniston study population while no association was observed for PCBs.

Type 1 diabetes in older adults: Comparing treatments and chronic complications in the United States T1D Exchange and the German/Austrian DPV registries.

AIMS: Compare characteristics, therapies and clinical outcomes in older adults with type 1 diabetes in the United States T1D Exchange (T1DX) and German/Austrian Diabetes Patienten Verlaufsdokumentation (DPV) registries. METHODS: Cross-sectional study of adults ≥60years old with type 1 diabetes seen in 2011-2012 in the T1DX (n=1283) and DPV (n=2014) registries. Wilcoxon rank-sum test was used for continuous variables and chi-square test for categorical variables. Adjusted analyses used generalized linear models. RESULTS: Individuals in both registries were similar in body mass index (mean 27kg/m2), percent with obesity (25%) and gender (48% male). In T1DX there was longer diabetes duration (32.3 vs. 28.8years), greater use of antihypertensive medications (including ACE-I and ARBs; 85% vs. 62%), statins (68% vs. 40%), aspirin (77% vs. 21%), insulin pumps (58% vs. 18%), and less smoking (7% vs. 10%); lower adjusted mean LDL-cholesterol (84 vs. 109mg/dL), and lower adjusted mean systolic and diastolic blood pressures (128 vs. 136 and 68 vs. 74mmHg); fewer myocardial infarctions (6% vs. 9% [99% CI of difference, 1% to 5%]), strokes (2% vs. 8% [3% to 7%]), microvascular complications including microalbuminuria (17% vs. 44% [22% to 32%]) but increased depression (16.1% vs. 8.7%). Adjusted mean HbA1c levels were similar (7.5%, 58mmol/mol). CONCLUSIONS: Differences between the registries included greater use of antihypertensives, statins and insulin pumps, and fewer chronic complications in the T1DX. Further research is needed to better understand the role of intensive therapy in improving outcomes in older adults with type 1 diabetes.

Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5).

OBJECTIVE: To compare the efficacy and safety of two doses of once-weekly dulaglutide, a glucagon-like peptide 1 receptor agonist, to sitagliptin in uncontrolled, metformin-treated patients with type 2 diabetes. The primary objective was to compare (for noninferiority and then superiority) dulaglutide 1.5 mg versus sitagliptin in change from baseline in glycosylated hemoglobin A1c (HbA1c) at 52 weeks. RESEARCH DESIGN AND METHODS: This multicenter, adaptive, double-blind, parallel-arm study randomized patients (N = 1,098; mean baseline age 54 years; HbA1c 8.1% [65 mmol/mol]; weight 86.4 kg; diabetes duration 7 years) to dulaglutide 1.5 mg, dulaglutide 0.75 mg, sitagliptin 100 mg, or placebo (placebo-controlled period up to 26 weeks). The treatment period lasted 104 weeks, with 52-week primary end point data presented. RESULTS: The mean HbA1c changes to 52 weeks were (least squares mean ± SE): -1.10 ± 0.06% (-12.0 ± 0.7 mmol/mol), -0.87 ± 0.06% (9.5 ± 0.7 mmol/mol), and -0.39 ± 0.06% (4.3 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg, and sitagliptin, respectively. Both dulaglutide doses were superior to sitagliptin (P < 0.001, both comparisons). No events of severe hypoglycemia were reported. Mean weight changes to 52 weeks were greater with dulaglutide 1.5 mg (-3.03 ± 0.22 kg) and dulaglutide 0.75 mg (-2.60 ± 0.23 kg) compared with sitagliptin (-1.53 ± 0.22 kg) (P < 0.001, both comparisons). The most common gastrointestinal treatment-emergent adverse events in dulaglutide 1.5- and 0.75-mg arms were nausea, diarrhea, and vomiting. CONCLUSIONS: Both dulaglutide doses demonstrated superior glycemic control versus sitagliptin at 52 weeks with an acceptable tolerability and safety profile.

Group diabetes education administered through telemedicine: tools used and lessons learned.

OBJECTIVE: To describe the use of telemedicine for teaching group diabetes education classes to individuals with diabetes mellitus in a rural medically underserved area. SUBJECTS AND METHODS: Adults with diabetes from a rural area served by Oswego Hospital in upstate New York were asked to participate in this study. Volunteers received diabetes education through real-time teleconferencing (n=27) by joining age- and sex-matched patients from the Joslin Diabetes Center, Syracuse, NY, in our "Living with Diabetes Class" (n=39). The two 3-h sessions offered comprehensive diabetes education by a diabetes nurse educator, dietitian, and exercise physiologist. These sessions were followed in 3 months by a 3-h follow-up class. Each group receiving tele-education consisted of two or three patients with diabetes. RESULTS: The hemoglobin A1c test (a blood test that estimates the overall average glucose levels over the past 3 months) improved in the face-to-face and the telemedicine groups. There was no significant change in weight between groups. Each group had significant improvements in scores on the Problem Areas In Diabetes survey, which is a measure of emotional functioning in diabetes. Diabetes treatment satisfaction as measured in the Diabetes Treatment Satisfaction Questionnaire improved in the face-to-face group but not in the telemedicine group. Although the face-to-face group had significantly higher scores in the Diabetes Treatment Satisfaction Questionnaire, the telemedicine group was highly satisfied with the services provided. CONCLUSIONS: Telemedicine offers an effective alternative approach for providing group diabetes education to individuals with poor access to diabetes education programs.

Diabetes prevention and control in the workplace: a pilot project for county employees.

OBJECTIVES: To improve nutrition and physical activity of county employees and promote weight loss. DESIGN: Random assignment to begin the program when first offered or after 3 months ("wait control" group). SETTING: Worksite. PARTICIPANTS: Onondaga County employees (n = 45) at risk for diabetes (n = 35) or with diabetes (n = 10). Mean (±SD) age = 51.2 (± 8.0) years and body mass index (BMI) = 37.3 ± (6.8 kg/m). INTERVENTION: Twelve weekly healthy lifestyle sessions based on the Diabetes Prevention Program curriculum, followed by monthly sessions for up to 12 months. OUTCOMES: Medical: Weight, BMI, waist circumference, blood pressure, fasting glucose, lipid, and hemoglobin A1c levels. Psychosocial/behavioral: Health-related quality of life Short Form-12, Impact of Weight on Quality of Life Scale), physical activity (International Physical Activity Questionnaire), eating behavior (3-Factor Eating Questionnaire, National Cancer Institute Fat Screener), job satisfaction. RESULTS: The intervention group lost significant weight compared to the wait control group over the first 3 months (mean [95% CI], -2.23 kg [-3.5 to 0.97]) vs [+ 0.73 kg (+0.17 to +1.28)], with a decrease in BMI (P < .001) and waist circumference (P = .004), an increase in physical activity (International Physical Activity Questionnaire, P = .011) and lower dietary fat intake (P = .018). Over 12 months, 22.5% (9/40) lost more than 5% body weight and 12.5% (5/40) lost more than 7% body weight. After the first 3 months, there was gradual partial weight regain but reduction in waist circumference was maintained. The intervention group demonstrated significant improvement in Impact of Weight on Quality of Life Scale (P < .001), 3-Factor Eating (cognitive restraint P < .001, uncontrolled eating P = .003, and emotional eating P = .001), International Physical Activity Questionnaire (P = .011), and Short Form-12 Physical Component Summary (P = .048). No improvements were observed in blood pressure, lipid, hemoglobin A1c, or glucose levels. Job satisfaction was inversely related to BMI at baseline (P = .001) with a trend for improvement with the modest weight loss. CONCLUSIONS: A worksite intervention program can help government employees adopt healthier lifestyles and achieve modest weight loss.

Food insecurity and food choices in rural older adults with diabetes receiving nutrition education via telemedicine.

OBJECTIVE: To evaluate differences between rural older adults with diabetes reporting the presence or absence of food insecurity with respect to meal planning, preparation, shopping, obesity, and glycemic control after receiving nutrition counseling through telemedicine. METHODS: Food insecurity data were obtained by telephone survey (n=74). Group differences for continuous variables were measured by t tests; categorical variables by Pearson chi-square tests. RESULTS: Participants reporting mild food insecurity (23%) had higher body mass index (35.5±7.1 kg/m2 vs 30.5±6.0 kg/m2, P=.01) and lower household incomes (P=.03) and were more likely to consider cost of ingredients in food preparation compared to food-secure participants (P=.03). Most purchased fresh produce (97%) and considered the dietitian's advice when purchasing food. Both groups report similar adherence to dietitians' advice and had similar glycemic control. CONCLUSIONS AND IMPLICATIONS: Strategies to address higher levels of obesity associated with food insecurity are needed.

Goal setting using telemedicine in rural underserved older adults with diabetes: experiences from the informatics for diabetes education and telemedicine project.

OBJECTIVE: To describe the use of telemedicine for setting goals for behavior change and examine the success in achieving these goals in rural underserved older adults with diabetes. MATERIALS AND METHODS: Medicare beneficiaries with diabetes living in rural upstate New York who were enrolled in the telemedicine intervention of the Informatics for Diabetes Education and Telemedicine (IDEATel) project (n = 610) participated in home televisits with nurse and dietitian educators every 4-6 weeks for 2-6 years. Behavior change goals related to nutrition, physical activity, monitoring, diabetes health maintenance, and/or use of the home telemedicine unit were established at the conclusion of each televisit and assessed at the next visit. RESULTS: Collaborative goal setting was employed during 18,355 televisits (mean of 33 goal-setting televisits/participant). The most common goals were related to monitoring, followed by diabetes health maintenance, nutrition, exercise, and use of the telemedicine equipment. Overall, 68% of behavioral goals were rated as "improved" or "met." The greatest success was achieved for goals related to proper insulin injection technique and daily foot care. These elderly participants had the most difficulty achieving goals related to use of the computer. No gender differences in goal achievement were observed. CONCLUSION: Televisits can be successfully used to collaboratively establish behavior change goals to help improve diabetes self-management in underserved elderly rural adults.

Use of three computer training methods in elderly underserved rural patients enrolled in a diabetes telemedicine program.

A telephone survey of Medicare beneficiaries with diabetes living in rural underserved areas and enrolled in the Informatics for Diabetes Education and Telemedicine project identified 109 subjects who requested further training in functions of the home telemedicine unit after initial in-home training by regional nurse installers. The initial training provided the skills needed to videoconferences with nurse case managers and to transmit blood glucose and blood pressure readings, but further instruction was needed for access to Web-based education features and messaging. This study evaluated these elderly patients' perceptions of the helpfulness of three additional telemedicine training methods:in-home visit with an regional nurse installer referencing a user's manual, unassisted patient use of the user's manual, and telephone-based training not using regional nurse installers reinforcing the user's manual. Eligible subjects rated the helpfulness of the three computer training methods on a five-point Likert scale (1 = "not helpful at all," 5 = "very helpful"). Participants rated "in-home" training with an regional nurse installer significantly higher than they did for the user's manual alone (P < .01). In response to this finding and other companion usability studies, Informatics for Diabetes Education and Telemedicine deployed home telemedicine units with enhanced remote training capabilities to better emulate characteristics of in-person training.

Effects of diet and/or exercise on the adipocytokine and inflammatory cytokine levels of postmenopausal women with type 2 diabetes.

This study examined the independent and combined effects of diet and exercise on adipocytokine and inflammatory cytokines in postmenopausal women with type 2 diabetes. Using a randomized, controlled design, 33 women (age, 50-70 years) were assigned to diet alone (D), exercise alone (EX), or diet + exercise (D + E) for 14 weeks. Before and after the interventions, blood samples for adipocytokines and inflammatory markers were drawn, a meal test was performed, and abdominal fat distribution was measured by magnetic resonance imaging (MRI). Body weight decreased approximately 4.5 +/- 0.6 kg ( P < .05) after the D and D + E interventions, whereas only small changes in body weight were found with the exercise-alone intervention. Plasma C-reactive protein levels were decreased by approximately 15% with all 3 interventions, whereas leptin levels were reduced with the D and D + E intervention (D: pre = 48.7 +/- 6.0, post = 38.9 +/- 5.0 ng/mL; D + E: pre = 38.5 +/- 6.0, post = 22.9 +/- 5.0 ng/mL; P < .05) with no differences between groups. There was a trend for leptin levels to decrease in the EX group ( P = .06). Plasma resistin levels were not altered by the 3 interventions from pre- to posttreatment (D: pre = 6.9 +/- 0.6, post = 6.2 +/- 0.4 ng/mL; D + E: pre = 5.6 +/- 0.6, post = 5.7 +/- 0.4 ng/mL; E: pre = 6.2 +/- 0.6, post = 5.9 +/- 0.6 ng/mL, P > .05), and no differences in adiponectin and tumor necrosis factor alpha (TNF- alpha ) levels were found. Visceral adipose tissue and tumor necrosis factor alpha were the only predictors of calculated insulin resistance ( P < .05), explaining 43% of the variability. A typically prescribed weight loss program with lifestyle changes resulted in few changes in adipocytokines and inflammatory cytokines in older women with type 2 diabetes, suggesting that dramatic weight loss or clinical interventions are needed.

The role of nurses in installing telehealth technology in the home.

Home telehealth involves the use of video conferencing or remote monitoring equipment in patients' homes. The installation of hardware and training of patients has historically been performed by nurses, typically RNs. This article examines the experience of RNs as telehealth installers in the Informatics for Diabetes Education and Telemedicine (IDEATel) project, where RNs were responsible for the installation of the Home Telemedicine Units (HTUs) and for training patients in the use of the HTUs, blood pressure cuffs, and fingerstick glucose meters. Average installation and training time was 166 minutes (SD 51 min). Structured interviews with RN installers revealed that patient education and training accounted for roughly two thirds of the in-home time. Technology-related problems, especially those related to telecommunications, were the primary cause of installation difficulties. Thematic analysis of installer interviews identified eight major themes and confirmed the importance of both clinical and technical knowledge during the telehealth installation process.

Regulation of hemopexin transcription by calcium ionophores and phorbol ester in hepatoma cells.

Hemopexin (Hx) is an acute-phase hepatic protein, whose transcription is upregulated by IL-6. The transcription rate of Hx was found to be increased 11-fold by the calcium ionophore A23187, 25-fold by the calcium ionophore ionomycin, and 4-5-fold by phorbol 12-myristate 13-acetate (PMA) in serum-starved H4IIE rat hepatoma cells. Insulin did not affect the transcription rate of Hx. These findings are consistent with involvement of intracellular calcium concentrations and activation of protein kinase C (PKC) action in the regulation of Hx.

A comparison of diabetes education administered through telemedicine versus in person.

OBJECTIVE: To determine whether diabetes education can be provided as effectively through telemedicine technology as through in-person encounters with diabetes nurse and nutrition educators. RESEARCH DESIGN AND METHODS: A total of 56 adults with diabetes were randomized to receive diabetes education in person (control group) or via telemedicine (telemedicine group) and were followed prospectively. The education consisted of three consultative visits with diabetes nurse and nutrition educators. The in-person and telemedicine groups were compared using measures of glycemic control (HbA(1c)) and questionnaires to assess patient satisfaction and psychosocial functioning as related to diabetes. Outcome measures were obtained at baseline, immediately after the completion of diabetes education, and 3 months after the third educational visit. RESULTS: Patient satisfaction was high in the telemedicine group. Problem Areas in Diabetes scale scores improved significantly with diabetes education (adjusted P < 0.05, before vs. immediately after education and 3 months after education), and the attainment of behavior-change goals did not differ between groups. With diabetes education, HbA(1c) improved from 8.6 +/- 1.8% at baseline to 7.8 +/- 1.5% immediately after education and 7.8 +/- 1.8% 3 months after the third educational visit (unadjusted P < 0.001, P = 0.089 adjusted for BMI and age), with similar changes observed in the telemedicine and in-person groups. CONCLUSIONS: Diabetes education via telemedicine and in person was equally effective in improving glycemic control, and both methods were well accepted by patients. Reduced diabetes-related stress was observed in both groups. These data suggest that telemedicine can be successfully used to provide diabetes education to patients.