Diabetes Technology &amp Therapeutics (DIABETES TECHNOL THE )

Publisher: Mary Ann Liebert

Description

This new peer-reviewed quarterly journal covers new technology and new products for the treatment, monitoring, diagnosis, and prevention of diabetes and its complications. Technologies include noninvasive glucose monitoring, implantable continuous glucose sensors, novel routes of insulin administration, genetic engineering, the artificial pancreas, measures of longterm control, computer applications for case management, telemedicine, the internet, and new medications.

Impact factor 2.29

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    Impact factor
  • 5-year impact
    2.25
  • Cited half-life
    3.80
  • Immediacy index
    0.82
  • Eigenfactor
    0.01
  • Article influence
    0.60
  • Website
    Diabetes Technology & Therapeutics website
  • Other titles
    Diabetes technology & therapeutics (Online), Diabetes technology & therapeutics, Diabetes technology and therapeutics
  • ISSN
    1557-8593
  • OCLC
    43498340
  • Material type
    Document, Periodical, Internet resource
  • Document type
    Internet Resource, Computer File, Journal / Magazine / Newspaper

Publisher details

Mary Ann Liebert

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    • Author's final version or publisher's version/PDF
    • Publisher's version/PDF may be used
    • On author's personal website, institution's intranet, or institutional repository
    • Authors may deposit in funder's designated repository after 12 months
    • Set statement to accompany deposit (see policy)
    • Publisher copyright and source must be acknowledged
    • NIH authors will have their final paper, (post peer review, copy-editing and proof-reading) deposited in PubMed Central on their behalf
  • Classification
    ​ blue

Publications in this journal

  • Diabetes Technology &amp Therapeutics 01/2015;
  • Pratik Agrawal, Alex Zhong, John B Welsh, Rajiv Shah, Francine R Kaufman
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    ABSTRACT: Background: The automatic Threshold Suspend (TS) feature of the MiniMed 530G system (Medtronic MiniMed, Inc., Northridge, CA), when enabled, suspends insulin delivery for up to 2 h when the sensor glucose (SG) value reaches a preset threshold. Materials and Methods: SG data from 20,973 patients who enabled the TS feature at their discretion and uploaded pump and sensor data to CareLink(®) (Medtronic MiniMed, Inc.) from October 15, 2013 to July 21, 2014 were analyzed. Comparisons between 758,382 patient-days wherein the TS feature was enabled at any time and 166,791 patient-days in which it was not enabled were made. Further comparisons were made between data collected during daytime (8:00 a.m. to 10:00 p.m.) and nighttime (10:00 p.m. to 8:00 a.m.) hours. Data from subsets of patients who enabled the TS feature all of the time (n=14,673) versus those who never enabled the TS feature (n=2,249) were also compared. Recovery from hypoglycemia during and after 2-h pump suspension events was also assessed. Results: The TS feature was enabled on 82% of patient-days. Patient-days in which the TS feature was enabled, compared with patient-days in which it was not, had 69% fewer SG values ≤50 mg/dL (0.64% vs. 2.09%, respectively; P<0.001). The reduction in hypoglycemia seen on TS-enabled days was more pronounced during nighttime than during daytime hours. SG data from full-time users of the TS feature reflected a 62% reduction in values ≤50 mg/dL and a 5.6% reduction in values ≥300 mg/dL compared with data from nonusers (P<0.001 for each). The median SG value at the start of 2-h suspensions was 60 (interquartile range [IQR], 57-66) mg/dL, immediately after was 87 (IQR, 63-123) mg/dL, and 4 h later was 164 (IQR, 117-220) mg/dL. Conclusions: The TS feature, when enabled consistently, reduced hypoglycemic exposure, and for those who had it enabled 100% of the time, hyperglycemia was also reduced.
    Diabetes Technology &amp Therapeutics 01/2015;
  • Wojciech Fendler, Danuta Roman-Liu, Tomasz Tokarski, Radoslaw Romanczuk, Wojciech Mlynarski
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    ABSTRACT: Background: Excessive force required to deliver a set dose of insulin as well as a localization of the push button and its upwards extension may result in significant difficulties to safely perform insulin injection, including bending/breakage of the injector's needle. The GensuPen2 (Copernicus/Bioton, Warsaw, Poland) pen has a unique spring-assisted delivery system and a lateral trigger device for injection of insulin to improve its ergonomics. We tested the force required to administer insulin using three pens: GensuPen2, NovoPen(®) 4 (Novo Nordisk, Bagsværd, Denmark), and HumaPen Ergo(®) (Eli Lilly, Indianapolis, IN). Materials and Methods: Using a certified dynamometer we tested injection force at three doses of insulin: 2, 30, and 60 U, using each of the three injectors (n=10) in triplicate. Area under the curve (AUC) and maximum force used were calculated for each series of injections. Results: When administering doses of 2, 30, and 60 units of insulin, the GensuPen2 (6.55±1.09, 6.52±1.92, and 6.89±1.15 N, respectively) required significantly lower maximum force than the NovoPen 4 (9.04±0.61, 12.96±1.45, and 15.42±0.99 N, respectively) and the HumaPen Ergo (17.66±1.88, 32.14±6.08, and 40.39±7.64 N, respectively) (all P<0.0001). The AUC of force used for insulin injection with GensuPen2 did not differ between doses (P=0.82). At all dose levels, GensuPen2 required significantly lower force than the other two injectors. Moreover, the mode of holding of GensuPen2 was more similar to the natural arrangement of the hand while gripping a cylindrical item in comparison with NovoPen 4 and HumaPen Ergo. Conclusions: Usage of the GensuPen2 injector with a lateral trigger location and spring-assisted delivery system reduces the force required for drug administration, especially at high doses of insulin.
    Diabetes Technology &amp Therapeutics 01/2015;
  • Sue A Brown, Boris P Kovatchev, Marc D Breton, Stacey M Anderson, Patrick Keith-Hynes, Stephen D Patek, Boyi Jiang, Najib Ben Brahim, Paul Vereshchetin, Daniela Bruttomesso, Angelo Avogaro, Simone Del Favero, Federico Boscari, Silvia Galasso, Roberto Visentin, Marco Monaro, Claudio Cobelli
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    ABSTRACT: Background: Studies of closed-loop control (CLC) systems have improved glucose levels in patients with type 1 diabetes. In this study we test a new CLC concept aiming to "reset" the patient overnight to near-normoglycemia each morning, for several consecutive nights. Subjects and Methods: Ten insulin pump users with type 1 diabetes (mean age, 46.4±8.5 years) were enrolled in a two-center (in the United States and Italy) randomized crossover trial comparing 5 consecutive nights of CLC (23:00-07:00 h) in an outpatient setting versus sensor-augmented insulin pump therapy of the same duration at home. Primary end points included time spent in 80-140 mg/dL as measured by continuous glucose monitoring overnight and fasting blood glucose distribution at 7:00 h. Results: Compared with sensor-augmented pump therapy, CLC improved significantly time spent between 80 and 140 mg/dL (54.5% vs. 32.2%; P<0.001) and between 70 and 180 mg/dL (85.4% vs. 59.1%; P<0.001); CLC reduced the mean glucose level at 07:00 h (119.3 vs. 152.9 mg/dL; P<0.001) and overnight mean glucose level (139.0 vs. 170.3 mg/dL; P<0.001) using a marginally lower amount of insulin (6.1 vs. 6.8 units; P=0.1). Tighter overnight control led to improved daytime control on the next day: the overnight/next-day control correlation was r=0.52, P<0.01. Conclusions: Multinight CLC of insulin delivery (artificial pancreas) results in significant improvement in morning and overnight glucose levels and time in target range, with the potential to improve daytime control when glucose levels were "reset" to near-normoglycemia each morning.
    Diabetes Technology &amp Therapeutics 01/2015;
  • Diabetes Technology &amp Therapeutics 01/2015;
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    ABSTRACT: Abstract We recently developed new electrochemiluminescence (ECL) insulin autoantibody (IAA) and glutamic acid decarboxylase 65 autoantibody (GADA) assays that discriminate high-affinity, high-risk diabetes-specific autoantibodies from low-affinity, low-risk islet autoantibodies (iAbs) detected by radioassay (RAD). Here, we report a further validation of the ECL-IAA and -GADA assays in 3,484 TrialNet study participants. The ECL assay and RAD were congruent in those with prediabetes and in subjects with multiple autoantibodies, but only 24% (P<0.0001) of single RAD-IAA-positive and 46% (P<0.0001) of single RAD-GADA-positive were confirmed by the ECL-IAA and -GADA assays, respectively. During a follow-up (mean, 2.4 years), 51% of RAD-IAA-positive and 63% of RAD-GADA-positive subjects not confirmed by ECL became iAb negative, compared with only 17% of RAD-IAA-positive (P<0.0001) and 15% of RAD-GADA-positive (P<0.0001) subjects confirmed by ECL assays. Among subjects with multiple iAbs, diabetes-free survival was significantly shorter if IAA or GADA was positive by ECL and negative by RAD than if IAA or GADA was negative by ECL and positive by RAD (P<0.019 and P<0.0001, respectively). Both positive and negative predictive values in terms of progression to type 1 diabetes mellitus were superior for ECL-IAA and ECL-GADA, compared with RADs. The prevalence of the high-risk human leukocyte antigen-DR3/4, DQB1*0302 genotype was significantly higher in subjects with RAD-IAA or RAD-GADA confirmed by ECL. In conclusion, both ECL-IAA and -GADA are more disease-specific and better able to predict the risk of progression to type 1 diabetes mellitus than the current standard RADs.
    Diabetes Technology &amp Therapeutics 01/2015;
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    ABSTRACT: Abstract Aims: Skin autofluorescence (AF) has been associated with complications of diabetes. We evaluated the influence of skin color and ethnicity on the association between skin AF and the presence of diabetes-related complications. Materials and Methods: In a multiethnic type 2 diabetes cohort we investigated all patients with available skin AF measurements. The associations between skin AF and hemoglobin A1c (HbA1c) and the presence of complications of diabetes were estimated, stratified for ethnicity and quartiles of ultraviolet reflectance percentage (R%). Results: In total, 810 patients (438 native Dutch, 372 non-Dutch) were included. Because of too low an R%, 32% of black Africans and 19% of Hindustanis were excluded. Non-Dutch patients had lower AF values compared with Dutch patients (median AF=2.69 [interquartile range (IQR), 2.26-3.09] vs. 3.06 [IQR, 2.65-3.50] arbitrary units; P<0.001), but the R% was also lower (non-Dutch, median R%=12% [IQR, 9-15%]; Dutch, median R%=18% [IQR, 14-23%]; P=0.027). In the multivariate analysis, skin AF was only a determinant for complications in patients with R% 25(th) percentile (macrovascular, odds ratio [OR]=1.71 [95% confidence interval (CI), 1.05-2.77] vs. 1.15 [95% CI, 0.55-2.40] in the lowest quartile of R%; microvascular, OR=1.81 [95% CI, 1.20-2.75] vs. OR=0.87 [95% CI, 0.50-1.51]). A similar pattern was observed for nephropathy, neuropathy, and retinopathy separately. In non-Dutch patients AF was not a significant determinant for diabetes complication risk, whereas HbA1c was for nephropathy, retinopathy, and neuropathy. Conclusions: Skin AF measurement is a valuable tool for the assessment of micro- and macrovascular complication risk in patients with light skin color types. Even after exclusion of patients with too low a reflectance, the current performance of the AGE Reader™ (DiagnOptics Technologies BV, Groningen, The Netherlands) was insufficient in darker-skinned patients.
    Diabetes Technology &amp Therapeutics 01/2015;
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    ABSTRACT: Abstract Background: This study investigated the relationship among β-cell function, metabolic control, and diabetic microvascular complications in patients with type 2 diabetes mellitus (T2DM). Subjects and Methods: In total, 885 patients with type 2 diabetes mellitus (DM) were recruited from January 2012 to January 2014 and grouped into three groups according to the area under the curve of C-peptide [AUC(C-pep)] during the 75-g oral glucose tolerance test. Logistic regression analyses were used to evaluate the association between C-peptide and microvascular complications. Results: The prevalence of diabetic microvascular complications decreased from the first to the third AUC(C-pep) tertile (P<0.01 for all), whereas the rates of nonalcoholic fatty liver disease (NAFLD) was positively associated with AUC(C-pep) values. Patients with lower AUC(C-pep) tertile exhibited higher levels of glycosylated hemoglobin and high-density lipoprotein cholesterol and longer duration of DM; however, levels of triglycerides, fasting C-peptide, 2-h C-peptide, body mass index, and homeostasis model assessment of insulin resistance index were lower compared with the third tertile. Comparison among patients with a similar DM duration showed a higher level of AUC(C-pep) was inversely associated with prevalence of microvascular complications. The odds ratios for nephropathy, retinopathy, and neuropathy in the lowest versus the highest AUC(C-pep) tertile were 3.10 (95% confidence interval, 2.01-4.78), 2.83 (1.73-4.64), and 2.04 (1.37-3.04) after adjustment for confounding factors. Conclusions: Higher AUC(C-pep) levels were associated with a decreased prevalence of microvascular complications and a good level of glycemic control, whereas higher endogenous insulin levels were linked to the components of metabolic syndrome and increased rates of NAFLD.
    Diabetes Technology &amp Therapeutics 01/2015; 17(1):29-34.
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    ABSTRACT: Abstract Background: Psychological insulin resistance (PIR) refers to reluctance of providers to prescribe and patients to take insulin. Processes and tools have been developed to address PIR. The purpose of this qualitative study was to examine current understanding and opinions of insulin therapy of primary care providers (PCPs) and patients with type 2 diabetes (both naive to insulin and insulin users). Subjects and Methods: Providers (n=23 PCPs) and patients (n=96) participated in 1:1 interviews and 12 racially/ethnically diverse focus groups, respectively, conducted by trained qualitative researchers using pilot-tested scripts. Participants examined insulin devices and needles while specific questions were asked about insulin therapy. Recorded sessions were transcribed and analyzed. Results: Salient themes related to injection resistance, patient adherence, health system barriers, and education emerged during the sessions. Provider knowledge about insulin injection devices and approaches varied and was often limited, particularly regarding needle sizes, which influenced prescribing practices and patient education. Other barriers included limited time and personnel. However, PCPs placed priority on continuing education on devices, needles, insulin adjustment, educational approaches, and cost. Patient focus groups revealed a strong desire for knowledge on injection logistics, particularly by insulin users who felt that they had received inadequate education. Most patients had limited experience with tools like shorter needles but would consider injecting if presented. Those who had self-injection experience were more willing to accept insulin. Cost concerns and need for information were frequently reported. Conclusions: Findings reveal that programs and tools designed to address problems associated with PIR have yet to be fully realized.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Aims/Hypothesis: This study investigated the accuracy of blood glucose meters for self-monitoring and its influence on glycated hemoglobin (HbA1c) levels and the frequency of hypoglycemic coma. Materials and Methods: Self-measured and simultaneously obtained laboratory blood glucose values from 9,163 patients with type 1 diabetes <18 years of age in the German/Austrian Diabetes Prospective Documentation Initiative registry were analyzed by investigating their compliance with the International Organization for Standardization (ISO) criteria (versions 2003 and 2013) and by error grid analyses. Regression models elucidated effects on glucose control and hypoglycemia rates. Results: Depending on the respective subgroup (defined by sex, age, duration of diabetes, mode of insulin therapy), 78.7-94.7% of the self-monitoring of blood glucose (SMBG) values met the old and 79.7-88.6% met the new ISO criteria. In Clarke and Parkes error grid analyses, the percentages of SMBG values in Zone A ranged between 92.8% and 94.6% (Clarke) and between 92.2% and 95.0% (Parkes). The patient group with SMBG devices measuring "far too low" (compared with the laboratory-obtained glucose levels) presented with a higher HbA1c level than those measuring "far too high," "too high," "identical/almost identical," or "too low" (based on quintiles of deviation). Performing "far too high" was associated with the highest rate of hypoglycemic coma in comparison with the other deviation quintiles. Conclusions: This study showed that current SMBG devices fulfilled neither the previous nor the new ISO criteria. Large deviations of the SMBG values from the "true" glucose levels resulted in higher HbA1c levels and markedly increased rates of hypoglycemic events.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Background: This study was designed to clarify the influence of metformin on serum carbohydrate antigen 199 (CA199) levels and its associated factors in Chinese type 2 diabetes mellitus (T2DM) patients. Subjects and Methods: In total, 1,253 T2DM patients were enrolled, including a non-metformin group (n=616), a short-term metformin group (at least 1 week to 2 years; n=325), and a long-term metformin group (≥2 years; n=312). Their clinical and biochemical characteristics were collected and compared. After 1 year, the biochemical parameters were re-examined in 296 patients. Sex hormones were determined, and associations between CA199 and other variables were assessed. Results: At baseline, the incidence of abnormal CA199 levels was 14.7%, 8.9%, and 4.7% in the non-metformin, short-term metformin, and long-term metformin groups, respectively. CA199 levels in females were significantly higher than in males (P<0.01) and decreased significantly with the time of taking metformin (25.60±13.68 U/mL in non-metformin controls vs. 17.62±10.87 U/mL in the short-term group vs. 10.54±8.14 U/mL in the long-term group; P=0.000). The correlation and multiple stepwise regression analysis revealed that glycosylated hemoglobin, metformin, gender, total cholesterol, and follicle-stimulating hormone were independent impact factors on CA199 concentrations (all P<0.05). Binary logistic regression revealed that the risk of abnormal CA199 concentrations of the total population with short-term metformin or long-term metformin treatment decreased 11% (odds ratio=0.89; P=0.001) and 30% (odds ratio=0.70; P=0.000), respectively, at baseline. After a 1-year follow-up, the incidence of high CA199 level decreased in both the short-term and the long-term metformin group compared with that of controls (P<0.05). The extent of CA199 decrease in the long-term metformin group was the greatest (-17% vs. -4.9% in the short-term group vs. 3% in controls, P=0.000), and the group's risk of high blood CA199 level was reduced 67% (odds ratio=0.33; P=0.023). The reduction in women was more apparent than that in men (-18% vs. -5%, P=0.000). Conclusions: Metformin therapy reduced the CA199 level in Chinese T2DM patients, and its greatest decrease occurred in women with longer therapeutic time.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Background: Discrimination has been linked to negative health outcomes, but little research has investigated different types of discrimination to determine if some have a greater impact on outcomes. We examined the differential effect of discrimination based on race, level of education, gender, and language on glycemic control in adults with type 2 diabetes. Patients and Methods: Six hundred two patients with type 2 diabetes from two adult primary care clinics in the southeastern United States completed validated questionnaires. Questions included perceived discrimination because of race/ethnicity, level of education, sex/gender, or language. A multiple linear regression model assessed the differential effect of each type of perceived discrimination on glycemic control while adjusting for relevant covariates, including race, site, gender, marital status, duration of diabetes, number of years in school, number of hours worked per week, income, and health status. Results: The mean age was 61.5 years, and the mean duration of diabetes was 12.3 years. Of the sample, 61.6% were men, and 64.9% were non-Hispanic black. In adjusted models, education discrimination remained significantly associated with glycemic control (β=0.47; 95% confidence interval, 0.03, 0.92). Race, gender and language discrimination were not significantly associated with poor glycemic control in either unadjusted or adjusted analyses. Conclusions: Discrimination based on education was found to be significantly associated with poor glycemic control. The findings suggest that education discrimination may be an important social determinant to consider when providing care to patients with type 2 diabetes and should be assessed separate from other types of discrimination, such as that based on race.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Background: The incidence of type 1 diabetes mellitus (T1DM) is increasing rapidly worldwide for children of every age group. Materials and Methods: A retrospective analysis of hospital registration data from five tertiary hospitals in Beijing, China, identified 485 patients (210 boys, 275 girls) younger than 15 years of age with newly diagnosed T1DM between 1995 and 2010. Results: From 1995 to 2010, the incidence of T1DM in patients <15 years of age ranged from 0.935-3.26 per 100,000 per year. During this period, the average age-standardized incidence rate was 1.7 per 100,000 per year, and the average annual increase in T1DM incidence was 4.36%. The highest rate increases occurred in boys and in patients <5 years of age. For both genders and all age groups, T1DM incidence increased at an accelerated rate after 2006. By 2020, the incidence of T1DM among children in Beijing is projected to increase by a factor of 1.69. Conclusions: The incidence of T1DM among patients younger than 15 years of age in Beijing increased from 1995 to 2010, with rates growing at an accelerated pace since 2006. Based on recent trends, we project continued rapid growth in the number of new childhood T1DM cases in Beijing.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Background: Closed-loop control clinical research trials have been considerably accelerated by in silico trials using the Food and Drug Administration-accepted type 1 diabetes mellitus (T1DM) simulator. We have recently demonstrated that postprandial insulin sensitivity (SI) in T1DM subjects was lower at breakfast (B) than lunch (L) and dinner (D), but not significantly, because of the small population size. The goal of this study was therefore to incorporate this novel information into the University of Virginia/Padova T1DM simulator and to reproduce in silico the observed circadian variability. Subjects and Methods: Twenty T1DM subjects received an identical mixed meal at B, L, and D. SI was calculated for each meal using the oral glucose minimal model. Seven SI daily patterns were identified, and their probabilities were estimated. Each in silico subject was linked to a time-varying SI profile, while random deviations of up to 40% were allowed. Results: Simulations were compared with experimental data. The integrated area above the basal glucose curve values were 2.60±0.91 (B), 1.38±0.91 (L), and 1.44±1.07 (D) 10(4) min·mg/dL in silico versus 2.87±1.65 (B), 1.98±1.56 (L), and 2.16±2.00 (D) 10(4) min·mg/dL in vivo. Incremental peak glucose values were 109±33 (B), 80±29 (L), and 81±30 (D) mg/dL in silico versus 136±39 (B), 126±37 (L), and 125±48 (D) mg/dL in vivo. Conclusions: The incorporation of a time-varying SI into the simulator makes this technology suitable for running multiple-meal scenarios, thus enabling a more robust design of artificial pancreas algorithms.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Background: This study applied a pharmacodynamic model-based approach to evaluate the long-term durability and glycemic control of pioglitazone in comparison with other oral glucose-lowering drugs in Japanese type 2 diabetes mellitus (T2DM) patients. Subjects and Methods: Japanese T2DM patients were enrolled in a prospective, randomized, open-label, blinded-end point study and received pioglitazone with or without other oral glucose-lowering drugs (excluding another thiazolidinedione [TZD]) (n=293) or oral glucose-lowering drugs excluding TZD (n=294). Treatment was adjusted to achieve glycosylated hemoglobin (HbA1c) <6.9%, and samples for fasting plasma glucose (FPG) and HbA1c were collected over 2.5-4 years. A simultaneous cascading indirect response model structure was applied to describe the time course of FPG and HbA1c. HbA1c levels were described using both an FPG-dependent and an FPG-independent function. To account for titration, drug effects for both treatment groups were implemented using a time-dependent Emax model. Results: Pioglitazone was superior in both time to maximum effect and the magnitude of reduction achieved in FPG and HbA1c. A greater reduction in median FPG (-21 mg/dL vs. -9 mg/dL) was observed with pioglitazone (P<0.05). Maximum drug effect for FPG was predicted to occur earlier (11 months) for pioglitazone than for the control group (14 months). The simulated additional reduction in FPG and HbA1c achieved with pioglitazone was predicted to be maintained beyond the currently observed study duration. Conclusions: Pioglitazone was found to result in improved glycemic control and durability compared with control treatment. This model-based approach enabled the quantification of differences in FPG and HbA1c for both treatment groups and simulation to evaluate longer-term durability on FPG and HbA1c.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Background: Medication adherence can be affected by many factors, including health literacy. The purpose of this study is to determine (1) if a relationship exists between health literacy and self-reported or objectively measured medication adherence and (2) which aspect or aspects of medication nonadherence are most associated with health literacy. Subjects and Methods: This is a multicenter, cross-sectional survey study of adult patients with type 2 diabetes mellitus (T2DM), taking one or more antidiabetes medication for ≥6 months with a hemoglobin A1c (HbA1c) measure on record. Data collected included patient demographics (age, gender, race, language, highest level of education, injectable diabetes medication use, last HbA1c, and diabetes medication refill history) and two survey instruments (the Morisky eight-item Medication Adherence Scale [MMAS-8] and the short-form Test of Functional Health Literacy in Adults [s-TOFHLA]). Descriptive statistics and bivariate correlations were assessed, along with linear and logistic regression. Results: One hundred ninety-two patients with an average HbA1c level of 8.1% were included. Of these subjects, 32.8% had limited health literacy as measured by the s-TOFHLA, 58.9% had low adherence as measured by MMAS-8, and 65.1% were nonadherent based on cumulative medication gap (CMG) analysis. Age was associated with s-TOFHLA (-0.411; P<0.01) and MMAS-8 (0.157; P<0.05) scores. HbA1c was associated with MMAS-8 (-0.209; P<0.01) and CMG (0.152; P<0.05) scores. There was no significant association between s-TOFHLA and MMAS-8 or CMG. However, s-TOFHLA was positively related to MMAS-8 question 8, assessing difficulty remembering to take medications (P=0.017). Conclusions: Health literacy level is not associated with self-reported or objectively measured medication adherence in underserved patients with T2DM. Lower health literacy scores are associated with a patient experiencing difficulty remembering to take medications.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Background: Insulin pumps are equipped with advanced functions. Intensive training and adherence are required for optimum use of the technology. We aimed to assess the association of various key elements in insulin pump functions on blood glucose control. Patients and Methods: Patients on insulin pump therapy were enrolled. Insulin pumps were downloaded (CareLink(®) Pro 3 software; Medtronic Minimed, Northridge, CA), and data were collected over an 8-12-week period. Glycemic control of patients was classified as controlled (hemoglobin A1c [HbA1c] level of 7.5% or less in adults and 8% or less in children) and uncontrolled based on HbA1c level at enrollment. Variables studied were use of sensors and duration, frequency of blood glucose monitoring, Bolus Wizard (Medtronic Minimed) use, frequency of correction boluses, and frequency of cannula changing. Results: Seventy-two patients were enrolled (50 children). Median age was 12 years for children and 27.5 years for adults. Respective median numbers of blood glucose checks were 4.4 and 3.2 for controlled and uncontrolled children (P<0.021) and 3.1 and 2.8 for controlled and uncontrolled adults, respectively. Respective frequency of Bolus Wizard use per day showed a median of 6 and 4.15 for controlled and uncontrolled children (P<0.001) and 3.8 and 3.5 for controlled and uncontrolled adults. Controlled children wore sensors for longer (5 vs. 2.9 days/week) and did more corrections (3.9 vs. 2.5). There was no difference in the frequency of changing the infusion cannula in children's or adults' groups. Conclusions: We conclude that the frequency of blood glucose monitoring and Bolus Wizard use have a favorable association with glycemic control. These observations were more significant in the children's groups. Our data shows that patients with better control tend to bolus more for correction and wear sensors longer.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Background: The accuracy of the Contour(®) Plus (Bayer HealthCare LLC, Diabetes Care, Whippany, NJ) blood glucose monitoring system (BGMS) was evaluated in two separate studies. Materials and Methods: In the laboratory study, fingerstick samples from 100 subjects were tested in duplicate using three test strip lots and assessed per International Organization for Standardization (ISO) 15197:2003, Section 7 (≥95% of results within ±15 mg/dL or ±20% of the reference result for samples with glucose concentrations <75 and ≥75 mg/dL, respectively) and ISO 15197:2013, Section 6.3 (≥95% of results within ±15 mg/dL or ±15% of the reference result for samples with glucose concentrations <100 and ≥100 mg/dL, respectively) accuracy criteria. In the clinical trial, 220 subjects with diabetes, naive to the BGMS, tested capillary glucose from fingertip and palm blood samples and completed an ease-of-use questionnaire. BGMS and YSI glucose analyzer results were compared. Results: In the laboratory study, 100% of results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria. In the clinical trial, 100% and 99.1% of subject fingerstick results and 98.1% and 96.7% of subject palm results met ISO 15197:2003 and ISO 15197:2013 accuracy criteria, respectively. By Parkes Consensus Error Grid analysis, 100% of subject fingerstick results and 98.1% of subject palm results were within Zone A (remainder within Zone B). Questionnaire results showed most subjects found the BGMS easy to use. Conclusions: The Contour Plus BGMS meets ISO 15197:2003 and ISO 15197:2013 accuracy criteria in the laboratory and when used by untrained individuals.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Background: Continuous subcutaneous insulin infusion (CSII) is increasing worldwide, mostly because of improved technology. The aim of this study was to evaluate the current status of CSII in Italy. Materials and Methods: Physicians from 272 diabetes centers received a questionnaire investigating clinical features, pump technology, and management of patients on CSII. Results: Two hundred seventeen centers (79.8%) joined the study and, by the end of April 2013, gave information about 10,152 patients treated with CSII: 98.2% with type 1 diabetes mellitus, 81.4% adults, 57% female, and 61% with a conventional pump versus 39% with a sensor-augmented pump. CSII advanced functions were used by 68% of patients, and glucose sensors were used 12 days per month on average. Fifty-eight percent of diabetes centers had more than 20 patients on CSII, but there were differences among centers and among regions. The main indication for CSII was poor glucose control. Dropout was mainly due to pump wearability or nonoptimal glycemic control. Twenty-four hour assistance was guaranteed in 81% of centers. A full diabetes team (physician+nurse+dietician+psychologist) was available in 23% of adult-care diabetes centers and in 53% of pediatric diabetes units. Conclusions: CSII keeps increasing in Italy. More work is needed to ensure uniform treatment strategies throughout the country and to improve pump use.
    Diabetes Technology &amp Therapeutics 12/2014;
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    ABSTRACT: Abstract Aim: This study looked at the association of adipokines, inflammatory and oxidative stress markers in subjects with the following phenotypes: metabolically healthy, nonobese (MHNO), metabolically healthy, obese (MHO), metabolically obese, nonobese (MONO), and metabolically obese, obese (MOO). Materials and Methods: Subjects with MHNO (n=462), MHO (n=192), MONO (n=315), and MOO (n=335) were randomly selected from the Chennai Urban Rural Epidemiology Study. Adiponectin, visfatin, resistin, high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), oxidized low-density lipoprotein (LDL), and monocyte chemoattractant protein-1 (MCP-1) were measured by enzyme-linked immunosorbent assay. Results: Levels of adiponectin were lowest in the MOO group, followed by the MONO, MHO, and the MHNO groups (P=0.042), whereas the levels of visfatin (P=0.042) and resistin (P=0.043) were highest in the MOO group, followed by the MONO, MHO, and the MHNO groups. Levels of hs-CRP (P=0.029), TNF-α (P=0.036), IL-6 (P=0.042), oxidized LDL (P=0.036), and MCP-1 (P=0.039) increased from the MHNO to MHO to MONO to MOO phenotypes. Linear regression analysis of the parameters with body mass index (BMI) and metabolic syndrome components showed that adiponectin is negatively associated with abdominal obesity (β=-0.060; P=0.039) and BMI (β=-0.076; P=0.009) and that TNF-α is negatively associated with high-density lipoprotein levels (β=0.114, P=0.049) even after adjusting for age and gender. hs-CRP (β=0.112, P=0.020) and oxidized LDL (β=0.114, P=0.050) showed a positive association with systolic blood pressure even after adjusting for age and gender. Conclusions: The metabolically obese phenotype is characterized by altered adipokine and inflammatory profiles, which could make this phenotype at high risk for type 2 diabetes mellitus and cardiovascular diseases.
    Diabetes Technology &amp Therapeutics 12/2014;