bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patient Satisfaction and Glycemic Control After 1 Year With Inhaled Insulin (Exubera) in Patients With Type 1 or Type 2 Diabetes
Authors: Rosenstock Julio , Cappelleri Joseph C. , Bolinder Björn , Gerber Robert A. 
Published: March 2007

OBJECTIVE—The aim of this study was to determine patient satisfaction in patients with type 1 or type 2 diabetes receiving an inhaled insulin or subcutaneous insulin regimen, as assessed by pooled analysis of two 12-week parent studies and 1-year extension studies.
RESEARCH DESIGN AND METHODS—In the 12-week parent studies, patients with type 1 (n = 70) or type 2 (n = 51) diabetes were randomized to an inhaled insulin or subcutaneous insulin regimen. In the 1-year extension studies, patients were allowed to select either treatment regimen. Patient satisfaction was assessed at baseline, week 12, and 1 year using the Patient Satisfaction with Insulin Therapy questionnaire.
RESULTS—Of the 60 patients who received inhaled insulin during the parent studies, 85.0% (n = 51) chose to continue treatment, 13.3% (n = 8) switched to subcutaneous insulin, and 1.7% (n = 1) did not continue. Of the 61 patients who received subcutaneous insulin, 21.3% (n = 13) chose to continue treatment, 75.4% (n = 46) switched to inhaled insulin, and 3.3% (n = 2) did not continue. From baseline (parent studies) to 1 year (extension studies), HbA1c reductions of 0.8% were sustained, and greater improvements were observed in the inhaled insulin group compared with the subcutaneous insulin group in terms of overall satisfaction (37.9 vs. 3.1%; P &lt; 0.01) and ease of use (43.2 vs. −0.9%; P &lt; 0.01).
CONCLUSIONS—Inhaled insulin was preferred over subcutaneous insulin, which resulted in greater patient satisfaction up to 1 year in patients with type 1 or type 2 diabetes with durable effects on HbA1c levels.
Reduced Mortality Associated With the Use of ACE Inhibitors in Patients With Type 2 Diabetes
Authors: Eurich Dean T. , Majumdar Sumit R. , Tsuyuki Ross T. , Johnson Jeffrey A. 
Published: March 2007

OBJECTIVE—ACE inhibitor therapy is widely used in lower-risk patients with type 2 diabetes to reduce mortality, despite limited evidence to support this clinical strategy. The aim of this study was to evaluate the association between ACE inhibitor use and mortality in patients with diabetes and no cardiovascular disease.
RESEARCH DESIGN AND SETTINGS—Using the Saskatchewan health databases, 12,272 new users of oral hypoglycemic agents were identified between the years of 1991 and 1996. We excluded 3,202 subjects with previous cardiovascular disease. Of the remaining subjects, 1,187 “new users” of ACE inhibitors were identified (ACE inhibitor cohort). Subjects not receiving ACE inhibitor therapy throughout the follow-up period served as the control cohort (n = 4,989). Subjects were prospectively followed until death or the end of 1999. Multivariate Cox proportional hazards models were used to assess differences in all-cause and cardiovascular-related mortality between cohort groups.
RESULTS—Subjects were 60.7 ± 13.7 years old, 43.6% female, and were followed for an average of 5.3 ± 2.1 years. Mean duration of ACE inhibitor therapy was 3.6 ± 1.8 years. We observed significantly fewer deaths in the ACE inhibitor group (102 [8.6%]) compared with the control cohort (853 [17.1%]), with an adjusted hazard ratio (HR) and 95% CI of 0.49 (0.40–0.61) (P &lt; 0.001). Cardiovascular-related mortality was also reduced (40 [3.4%] vs. 261 [5.2%], adjusted HR, 0.63 [0.44–0.90]; P = 0.012).
CONCLUSIONS—The use of ACE inhibitors was associated with a significant reduction in all-cause and cardiovascular-related mortality in a broad spectrum of patients with type 2 diabetes and no cardiovascular disease.
Improved Glycemic Control With No Weight Increase in Patients With Type 2 Diabetes After Once-Daily Treatment With the Long-Acting Glucagon-Like Peptide 1 Analog Liraglutide (NN2211)
Authors: Madsbad Sten , Schmitz Ole , Ranstam Jonas , Jakobsen Grethe , Matthews David R. ,   on behalf of the NN2211-1310 International Study Group
Published: March 2007

OBJECTIVE—Liraglutide is a long-acting glucagon-like peptide 1 analog designed for once daily injection. This study assessed the efficacy and safety of liraglutide after 12 weeks of treatment in type 2 diabetic patients.
RESEARCH DESIGN AND METHODS—A double-blind, randomized, parallel-group, placebo-controlled trial with an open-label comparator arm was conducted among 193 outpatients with type 2 diabetes. The mean age was 56.6 years and the mean HbA1c was 7.6% across the treatment groups. Patients were randomly assigned to one of five fixed-dosage groups of liraglutide (0.045, 0.225, 0.45, 0.60, or 0.75 mg), placebo, or open-label sulfonylurea (glimepiride, 1–4 mg). The primary end point was HbA1c after 12 weeks; secondary end points were fasting serum glucose, fasting C-peptide, fasting glucagon, fasting insulin, β-cell function, body weight, adverse events, and hypoglycemic episodes.
RESULTS—A total of 190 patients were included in the intention-to-treat (ITT) analysis. HbA1c decreased in all but the lowest liraglutide dosage group. In the 0.75-mg liraglutide group, HbA1c decreased by 0.75 percentage points (P &lt; 0.0001) and fasting glucose decreased by 1.8 mmol/l (P = 0.0003) compared with placebo. Improvement in glycemic control was evident after 1 week. Body weight decreased by 1.2 kg in the 0.45-mg liraglutide group (P = 0.0184) compared with placebo. The proinsulin-to-insulin ratio decreased in the 0.75-mg liraglutide group (−0.18; P = 0.0244) compared with placebo. Patients treated with glimepiride had decreased HbA1c and fasting glucose, but slightly increased body weight. No safety issues were raised for liraglutide; observed adverse events were mild and transient.
CONCLUSIONS—A once-daily dose of liraglutide provides efficacious glycemic control and is not associated with weight gain. Adverse events with the drug are mild and transient, and the risk of hypoglycemia is negligible.
Comparative Roles of Microvascular and Nerve Function in Foot Ulceration in Type 2 Diabetes
Authors: Krishnan Singhan T.M. , Baker Neil R. , Carrington Anne L. , Rayman Gerry 
Published: March 2007

OBJECTIVE—To determine the relative roles of different modalities of sensory nerve function (large and small fiber) and the role of microvascular dysfunction in foot ulceration in type 2 diabetic subjects.
RESEARCH DESIGN AND METHODS—A total of 20 control subjects and 18 type 2 diabetic subjects with foot ulceration and 20 without were studied. None of the subjects had clinical features of peripheral vascular disease. The Computer-Aided Sensory Evaluator IV (CASE IV) was used to determine vibration detection threshold (VDT), cold detection threshold (CDT), warm detection threshold (WDT), and heat pain onset threshold (HPO). Vibration perception threshold (VPT) was also assessed by a neurothesiometer. Microvascular function (maximum hyperemia to skin heating to 44°C) was assessed using laser Doppler flowmetry (mean maximum hyperemia using laser Doppler flowmeter [LDFmax]), laser Doppler imaging (mean maximum hyperemia using laser Doppler imager [LDImax]), and skin oxygenation with transcutaneous oxygen tension (TcpO2).
RESULTS—VPT, VDT, CDT, and HPO were all significantly higher in individuals with ulceration than in those without (VPT and VDT: P &lt; 0.0001) (CDT and HPO: P = 0.01). LDFmax, LDImax, and TcpO2 were significantly lower in the two diabetic groups than in the control subjects, but there was no difference between individuals with and without ulceration. Univariate logistic regression analysis revealed similar odds ratios for foot ulceration for VDT, CDT, HPO, and VPT (OR 1.97 [95% CI 1.30–2.98], 1.58 [1.20–2.08], 2.30 [1.21–4.37], and 1.24 [1.08–1.42], respectively). None of the microvascular parameters yielded significant odds ratios for ulceration.
CONCLUSIONS—This study found that there was no additional value in measuring small-fiber function with the CASE IV over measuring vibration by either CASE IV or the inexpensive neurothesiometer in discriminating between individuals with and without ulceration. Furthermore, none of the tests of microvascular function including the TcpO2 were able to discriminate between individuals with and without ulceration, suggesting that such tests may not be of benefit in identifying subjects at greater risk of foot ulceration.
Using Metabolic Syndrome Traits for Efficient Detection of Impaired Glucose Tolerance
Authors: Meigs James B. , Williams Ken , Sullivan Lisa M. , Hunt Kelly J. , Haffner Steven M. , Stern Michael P. , González Villalpando Clicerio , Perhanidis Jessica S. , Nathan David M. , D’Agostino Ralph B. , D’Agostino Ralph B. , Wilson Peter W.F. 
Published: March 2007

OBJECTIVE—Efficient detection of impaired glucose tolerance (IGT) is needed to implement type 2 diabetes prevention interventions.
RESEARCH DESIGN AND METHODS—We assessed the capacity of the metabolic syndrome (MetS) to identify IGT in a cross-sectional analysis of 3,326 Caucasian Framingham Offspring Study (FOS), 1,168 Caucasian and 1,812 Mexican-American San Antonio Heart Study (SAHS), 1,983 Mexico City Diabetes Study (MCDS), and 452 Caucasian, 407 Mexican-American, and 290 African-American Insulin Resistance Atherosclerosis Study (IRAS) men and women aged 30–79 years who had a clinical examination and an oral glucose tolerance test (OGTT) during 1987–1996. Those with diabetes treatment or fasting plasma glucose ≥7.0 mmol/l were excluded (MetS was defined by Third Report of the National Cholesterol Education Program’s Adult Treatment Panel criteria and IGT as 2-h postchallenge glucose [2hPG] ≥7.8 mmol/l). We calculated positive (PPV) and negative predictive values (NPV), population attributable risk percentages (PAR%), age- and sex-adjusted odds ratios (ORs), and areas under the receiver operating characteristic curve (AROCs) associated with MetS traits.
RESULTS—Among FOS, SAHS, and MCDS subjects, 24–43% had MetS and 15–23% had IGT (including 2–5% with 2hPG ≥11.1 mmol/l). Among those with MetS, OR for IGT were 3–4, PPV were 0.24–0.41, NPV were 0.84–0.91, and PAR% were 30–40%. Among subjects with MetS defined by impaired fasting glucose (IFG) and any two other traits, OR for IGT were 9–24, PPV were 0.62–0.89, NPV were 0.78–0.87, and PAR% were 3–12%. Among IRAS subjects, 24–34% had MetS and 37–41% had IGT. Among those with MetS, ORs for IGT were 3–6, PPVs were 0.57–0.73, and NPVs were 0.67–0.72. In logistic regression models, IFG, large waist, and high triglycerides were independently associated with IGT (AROC 0.71–0.83) in all study populations.
CONCLUSIONS—The MetS, especially defined by IFG, large waist, and high triglycerides, efficiently identifies subjects likely to have IGT on OGTT and thus be eligible for diabetes prevention interventions.
The Burden of Treatment Failure in Type 2 Diabetes
Authors: Brown Jonathan B. , Nichols Gregory A. , Perry Andrew 
Published: March 2007

OBJECTIVE—In type 2 diabetes, therapies to maintain blood glucose control usually fail after several years. We estimated the glycemic burden that accumulates from treatment failure and describe the time course and predictors of failure.
RESEARCH DESIGN AND METHODS—A prospective, population-based study using retrospective observational data. We identified all 7,208 complete courses of treatment with nondrug therapy, sulfonylurea monotherapy, metformin monotherapy, and combination oral antihyperglycemic therapy between 1994 and 2002, inclusive, among members of the Kaiser Permanente Northwest Region. We calculated mean cumulative glycemic burden, defined as HbA1c-months &gt;8.0 or 7.0% for each treatment. We then measured the likelihood that the next HbA1c would exceed 8.0 and 7.0% after HbA1c exceeded each of ten hypothetical treatment thresholds. Finally, we estimated multivariate logistic regression models to predict when HbA1c would continue to deteriorate.
RESULTS—In this well-controlled population, the average patient accumulated nearly 5 HbA1c-years of excess glycemic burden &gt;8.0% from diagnosis until starting insulin and about 10 HbA1c-years of burden &gt;7.0%. Whenever patients crossed the American Diabetes Association-recommended treatment threshold of 8.0%, their next HbA1c result was as likely to be &lt;8.0 as &gt;8.0%. Multivariate prediction models had highly statistically significant coefficients, but predicted &lt;10% of the variation in future HbA1c results.
CONCLUSIONS—Clinicians should change glucose-lowering treatments in type 2 diabetes much sooner or use treatments that are less likely to fail. An action point at 7.0% or lower is more likely to prevent additional deterioration than the traditional action point of 8.0%.
Albumin Excretion Rate Is Not Affected by Asymptomatic Urinary Tract Infection
Authors: Hernández Cristina , Simó Rafael 
Published: March 2007

OBJECTIVE—The aim of the study was to evaluate whether asymptomatic urinary tract infection (UTI) significantly influences the level of albumin excretion rate (AER) in diabetic patients.
RESEARCH DESIGN AND METHODS—We screened prospectively for UTI and AER in 765 type 2 diabetic subjects. AER was determined before and after antimicrobial therapy in those patients in whom an asymptomatic UTI was diagnosed (n = 59). To interpret the clinical significance of AER changes, the coefficient of biological variation (CVb) of the AER (CVb-AER) was assessed in a control group of type 2 diabetic patients without UTI (n = 56).
RESULTS—AER did not change after antimicrobial treatment either in the whole group of patients with UTI (pre: 13.8 μg/min [0.1–195] vs. post: 8.5 μg/min [0.1–185]; P = 0.1) or in those patients in whom the infection was eradicated (pre: 11.7 μg/min [0.1–195] vs. post: 7.1 μg/min [0.1–185]; NS). The CVb-AER was 64% in the control group and was inversely correlated with AER (r = −0.44; P = 0.001). The decrease of AER after antimicrobial therapy (55%) did not exceed the biological variation of AER (64%). Finally, UTI did not significantly influence the classification of diabetic patients as normo- or microalbuminuric.
CONCLUSIONS—Asymptomatic UTI does not increase AER in type 2 diabetic patients. Therefore, our results suggest that testing for UTI is not necessary when AER is measured in diabetic patients.
A Multinational Comparison of Complications Assessment in Type 1 Diabetes
Authors: Walsh Michael G. , Zgibor Janice , Borch-Johnsen Knut , Orchard Trevor J. ,   on behalf of the DiaComp Investigators
Published: March 2007

OBJECTIVE—To describe the global geographic variation of micro- and macrovascular complications in childhood-onset type 1 diabetes assessed by both reported and measured disease and risk factors and relate any such variation to diabetes control and health care activities.
RESEARCH DESIGN AND METHODS—The DiaComp study is a multinational (17 countries) cross-sectional study of complications in type 1 diabetes and is comprised of two levels (level 1 includes survey only and level 2 includes survey plus examination). This report concerns level 2, representing 12 countries (n = 892). All participants were diagnosed at &lt;15 years of age and had a diabetes duration of 5–24 years when surveyed. All complications were assessed by self-report and for microalbuminuria by Micral II dipstick, neuropathy by the Michigan Neuropathy Screening Instrument exam, and hypertension using the Hypertension Detection and Follow-up Program (HDFP) protocol. HbA1c was determined by using the DCA analyzer.
RESULTS—A wide variation in neuropathy, reported renal disease/proteinuria, and hypertension among those of short diabetes duration was noted, with central Europe (Romania and Lithuania) standing out for both self-reported renal disease and measured microalbuminuria and for both self-reported and examined neuropathy. The Caribbean (Puerto Rico) also had high rates of microalbuminuria and examined neuropathy. For those of long duration, variation was more moderate. We found generally good agreement between the reported and clinically determined measures for neuropathy (r = 0.5, P = 0.01) and hypertension (r = 0.61, P = 0.001) as demonstrated by the high overall correlation between examination and self-report for these two complications. However, the agreement between examination and self-report for renal disease/proteinuria was less, with low overall correlation (r = −0.05, P = 0.86) and incongruous centers (Slovakia and Finland). Geographic variation in prevalence was not consistently explained for all complications, even with strong independent prediction by systolic blood pressure, although the variation in microalbuminuria was largely accounted for by self-monitored blood glucose, which was significantly protective.
CONCLUSIONS—This report has identified wide variation and geographic patterns in complication prevalence, with a further indication that self-report is generally in agreement with examined prevalence, though less for renal disease/proteinuria. However, this level of DiaComp, with more complete assessment of risk factors and health care practice, was still not able to completely explain the variation in complication prevalence, except for microalbuminuria.
The Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive)
Authors: Charbonnel Bernard , Dormandy John , Erdmann Erland , Massi-Benedetti Massimo , Skene Allan ,   PROactive Study Group
Published: March 2007

OBJECTIVE—The PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive) assesses the effect of pioglitazone, a peroxisome proliferator-activated receptor agonist, with anti-inflammatory and vascular properties, on the secondary prevention of macrovascular events in type 2 diabetes.RESEARCH DESIGN AND METHODS—PROactive is an on-going randomized, double-blind outcome study in patients with type 2 diabetes managed with diet and/or oral blood glucose-lowering drugs (combination of oral agents with insulin is permitted) who have a history of macrovascular disease. Patients are randomized to receive pioglitazone (forced titration from 15 to 30 to 45 mg, depending on tolerability) or placebo in addition to existing therapy. The primary end point is the time from randomization to occurrence of a new macrovascular event or death. Follow-up is estimated to span 4 years.RESULTS—A total of 5,238 patients have been randomized from 19 countries. At entry into the study, patients enrolled are a mean age of 61.8 years, with type 2 diabetes for a mean of 9.5 years; 60.9 and 61.5% are taking metformin or a sulfonylurea, respectively; and 33.6% are using insulin in addition to oral glucose-lowering drugs. The majority of patients are men (66.1%). Patients are required to meet one or more of entry criteria, as follows: &gt;6 months’ history of myocardial infarction (46.7%); coronary artery revascularization (30.8%), stroke (18.8%), or acute coronary syndrome for &gt;3 months (13.7%); other evidence of coronary artery disease (48.1%); or peripheral arterial occlusive disease (19.9%). One-half (48.5%) of the patients have two or more of these risk factors. Three-quarters (75.4%) have hypertension, and 58.8% are current or previous smokers.CONCLUSIONS—The cohort of patients enrolled in PROactive is a typical type 2 diabetic population at high risk of further macrovascular events. The characteristics of this population are ideal for assessing the ability of pioglitazone to reduce the cardiovascular risk of patients with type 2 diabetes.
Disturbed Eating Behavior and Eating Disorders in Preteen and Early Teenage Girls With Type 1 Diabetes
Authors: Colton Patricia , Olmsted Marion , Daneman Denis , Rydall Anne , Rodin Gary 
Published: March 2007

OBJECTIVE—To compare the prevalence of eating disturbances in preteen and early teenage girls with type 1 diabetes to their nondiabetic peers.
RESEARCH DESIGN AND METHODS—A cross-sectional, case-controlled study of 101 girls with type 1 diabetes, ages 9–14 years, and 303 age-matched, female nondiabetic control subjects was conducted. Participants completed a Children’s Eating Disorder Examination interview. Socioeconomic status, BMI, and diabetes-related variables were assessed. Groups were compared using χ2 analyses.
RESULTS—Binge eating; the use of intense, excessive exercise for weight control; the combination of two disturbed eating-related behaviors; and subthreshold eating disorders were all more common in girls with type 1 diabetes. Metabolic control was not related to eating behavior in this study population.
CONCLUSIONS—Eating disturbances, though mostly mild, were significantly more common in preteen and early teenage girls with type 1 diabetes. Screening and prevention programs for this high-risk group should begin in the preteen years.
Cooling Detection Thresholds in the Assessment of Diabetic Sensory Polyneuropathy
Authors: Zinman Lorne H. , Bril Vera , Perkins Bruce A. 
Published: March 2007

OBJECTIVE—Cooling detection threshold testing may be an important quantitative method for assessing polyneuropathy, in that it has traditionally been viewed as a measure of small-fiber involvement. The present study sought to determine the agreement between two common testing devices and to determine whether these are concordant in their association with predictor variables for diabetic sensory polyneuropathy.
RESEARCH DESIGN AND METHODS—A total of 83 patients with diabetes (10 patients with type 1 diabetes and 73 patients with type 2 diabetes) and a wide spectrum of diabetic sensory polyneuropathy severity underwent concurrent cooling detection threshold testing using the Medoc and CASE IV instruments. Common predictor variables for diabetic sensory polyneuropathy were measured on the same day.
RESULTS—Measurements of cooling detection thresholds by both instruments were highly correlated (Spearman’s correlation coefficient 0.81, P &lt; 0.001) and demonstrated a high degree of agreement by the method of Bland and Altman (95% distribution critical values for the difference in cooling detection thresholds, +7.5 and −5.6°C). Cooling detection thresholds by both instruments were strongly correlated with clinical indicators of large-fiber neuropathy but not with the symptoms of small-fiber neuropathy (pain).
CONCLUSIONS—These two instruments available for assessment of cooling detection thresholds are interchangeable for research in diabetic sensory polyneuropathy. However, this modality is equivalent to other modalities of quantitative sensory threshold testing in its association with indicators of large-fiber neuropathy and does not seem to provide an advantage for the prediction of small-fiber involvement.