Journal of diabetes science and technology

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ISSN 1932-2968

Publications in this journal

  • Journal of diabetes science and technology 02/2015;
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    ABSTRACT: Adoption of electronic health records (EHRs) has increased dramatically since the 2009 implementation of the Health Information Technology for Economic and Clinical Health (HITECH) Act. The latest data from the Centers for Disease Control and Prevention (CDC) indicate that the majority of U.S. hospitals and nearly half of U.S. health care professionals have implemented an EHR with advanced functionality.(1) The goals of the HITECH act were not only to incentivize the adoption of EHRs, but also to increase the quality, safety, and efficiency of health care by promoting the concept of "meaningful use."(2,3) The stepwise implementation of "meaningful use" is now entering the latter stages with a focus on improving patient outcomes.(4.) © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: Any intervention in patients with diabetes must consider its effect on both the incidence of hypoglycemia and hemoglobin A1c. Yet, there is no single metric that expresses these key factors simultaneously. Such a composite metric would permit clinicians, regulators, manufacturers, payers, and researchers to more easily evaluate the merits of an intervention as well as enable the comparison of qualitatively different interventions. This article proposes a composite metric, the hypoglycemia-A1c score (HAS), as the basis for a more comprehensive approach for the stakeholders in diabetes treatment to better understand how an intervention affects diabetes management. The article also demonstrates how additional parameters such as effects on weight, quality of life, and costs could be included in such a scoring system. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: An 8-mm needle length is commonly used for insulin injections; however, recent recommendations suggest shorter needles may help patients avoid intramuscular injections and reduce pain, while maintaining adequate glucose control. The goal of these analyses was to compare the pharmacokinetics (PK) and glucodynamics (GD) of insulin lispro after a 5-mm or an 8-mm injection depth administration in 2 populations: normal weight (study 1) or obese (study 2). In both open-label, randomized, 2-period crossover euglycemic clamp studies, subjects received single 0.25 U/kg insulin lispro doses on 2 occasions (at 5-mm and 8-mm injection depths); samples for PK and GD analyses were collected up to 6 hours postdose. Noncompartmental PK parameters AUC0-tlast, AUC0-∞, Cmax and GD parameters Gtot, Rmax, tRmax were log-transformed prior to analysis using a mixed effects model. There were no apparent differences between PK profiles at the 5-mm or 8-mm injection depth in either study, demonstrated by the ratios of geometric means of AUC0-tlast, AUC0-∞, and Cmax being close to 1, with 90% confidence intervals (CI) within (0.80, 1.25). There were no apparent differences between GD profiles at either injection depth with the ratios of Gtot and Rmax near unity and 90% CIs that included 1. In both studies, the tRmax values were similar between injection depths, with a small median of pairwise differences and a 90% CI that included zero. Injection depths in the 5-8 mm range did not affect the PK or GD of insulin lispro in normal weight or obese subjects. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: The reimbursement model for medical devices and supplies used in the management of diabetes in Canada, along with the process for assessing new health technologies, can be complicated. Various provincial programs, including Ontario's Assistive Devices Program and the Ontario Monitoring for Health Program, reimburse the costs associated with certain devices and supplies for diabetes management. In addition, provincial advisory committees, such as the Ontario Health Technology Advisory Committee, review and make recommendations on the adoption of new health technologies in each province. This article provides an overview of the reimbursement programs available for diabetes devices and supplies and reviews the process for assessing new health technologies using the province of Ontario as an example. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: Exhaled acetone analysis has long been recognized as a supplementary tool for diagnosis and monitoring diabetes, especially type 1 diabetes. It is essential, therefore to determine the relationship between exhaled acetone concentration and glucose in blood. Usually, a direct linear correlation between this both compounds has been expected. However, in some cases we can observe a reverse correlation. When blood glucose was increasing, breath acetone declined. The breath analysis as a supplementary tool for diagnosing and monitoring diabetes makes sense only in case of utilization of portable analyzers. This need has created a market for gas sensors. However, commercially available acetone gas sensors are developed for measuring samples at several tens part per million. The exhaled acetone concentration was measured using commercial acetone gas sensor (TGS 822, 823 Figaro, Arlington Heights, IL, USA Inc) with micropreconcentrator in low temperature cofired ceramics. The reference analyzer-mass spectrometry (HPR-20 QIC, Hiden Analytical, Warrington, UK) was used. Twenty-two healthy volunteers with no history of any respiratory disease participated in the research, as did 31 patients diagnosed with type 1 diabetes. Respectively, 3 healthy volunteer and 5 type 1 diabetes mellitus subjects with reverse trend were selected. The linear fitting coefficient various from 0.1139 to 0.9573. Therefore, it is necessary to determine the correlation between blood glucose concentrations and under different conditions, for example, insulin levels, as well as correlate the results with clinical tests, for example, Hb1Ac. It is well known that the concentration of acetone is strongly influenced by diet, insulin treatment, and so on. Therefore, much more complex analysis with long-term measurements are required. Thus, presented results should be regarded as tentative, and validation studies with the analysis of clinical test and in a large number of patients, including control groups, need to be carried out. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: Previous studies have shown interference with HbA1c measurement from the 4 most common heterozygous Hb variants (HbAS, HbAE, HbAC, and HbAD) with some assay methods. Here we examine analytical interference from 49 different less common variants with 7 different HbA1c methods using various method principles. Hb variants were screened using the Bio-Rad Variant or Variant II beta thal short program, confirmed by alkaline and acid electrophoresis, and identified by sequence analysis. The Trinity ultra2 boronate affinity high-performance liquid chromatography (HPLC) method and Roche Tinaquant immunoassay were used as primary and secondary comparative methods, respectively, since these methods are least likely to show interference from Hb variants. Other methods included were the Tosoh G7 and G8, Bio-Rad D-10 and Variant II Turbo, Diazyme Enzymatic, and Sebia Capillarys 2 Flex Piercing. To eliminate any inherent calibration bias, results for each method were adjusted using regression verses the ultra2 with nonvariant samples. Each method's calibration-adjusted results were compared and judged to be acceptable if within the 99% prediction interval of the regression line for nonvariant samples. Almost all variant samples were recognized as such by the ion-exchange HPLC methods by the presence of abnormal peaks or results outside the reportable range. For most variants, interference was seen with 1 or more of the ion-exchange methods. Following manufacturer instructions for interpretation of chromatograms usually, but not always, prevented reporting of inaccurate results. Laboratories must be cautious about reporting results when the presence of a variant is suspected. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
  • Journal of diabetes science and technology 02/2015;
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    ABSTRACT: Hemoglobin A1c (HbA1c) measurement has come to be a cornerstone in modern diabetes therapy. However, the methodological aspects of this type of measurement have been given little attention lately due to its position as an established method of choice. Nevertheless, quite a number of issues face practical application, such as clinically relevant differences between different measurement methods-both lab-based and point-of-care (POCT) systems will show better or worse diabetes management results after switching methods; and there are a number of possible reasons that need to be known and observed in practice. The aim of this review is to draw attention to these problems from a German point of view and provide suggestions for appropriate measures to improve the situation. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: HbA1c, a routinely used integrated measure of glycemic control, is traditionally thought to be equivalent to mean blood glucose in hematologically normal individuals. Therefore, particularly as the methodology of measuring HbA1c has been standardized, clinical decisions dependent on mean blood glucose are often predominantly decided based on the interpretation of measured HbA1c. In this commentary, however, now that a more routine method of measuring red cell life span has been developed, we present evidence that the relationship between HbA1c and mean blood glucose is influenced by variation in red blood cell survival even in the hematologically normal. This variation has consequences for the appropriate interpretation of HbA1c in diverse clinical conditions such as the diagnosis of diabetes and management of diabetes in chronic kidney disease. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: The PaQ® insulin delivery system is a simple-to-use patch-on device that provides preset basal rates and bolus insulin on demand. In addition to feasibility of use, safety, and efficacy (reported elsewhere), this study analyzed the impact of PaQ on patient-reported outcomes, including barriers to insulin treatment, diabetes-related distress, and attitudes toward insulin therapy in patients with type 2 diabetes on a stable multiple daily injection (MDI) regimen. This single-center, open-label, single-arm study comprised three 2-week periods: baseline (MDI), transition from MDI to PaQ, and PaQ treatment. Validated questionnaires were administered during the baseline and PaQ treatment periods: Barriers to Insulin Treatment questionnaire (BIT), Insulin Treatment Appraisal Scale (ITAS), and Problem Areas in Diabetes scale (PAID). Eighteen patients (age 59 ± 5 years, diabetes duration 15 ± 7 years, 21% female, HbA1c 7.7 ± 0.7%) completed the questionnaires. There was a strong, significant effect of PaQ use in mean BIT total scores (difference [D] = -5.4 ± 0.7.7, P = .01, effect size [d] = 0.70). Patients perceived less stigmatization by insulin injection (D = -2.2 ± 6.2, P = .18, d = 0.35), increased positive outcome (D = 1.9 ± 6.6, P = .17, d = 0.29), and less fear of injections (1.3 ± 4.8, P = .55, d = 0.28). Mean change in ITAS scores after PaQ device use showed a nonsignificant improvement of 1.71 ± 5.63 but moderate effect size (d = 0.30, P = .14). No increase in PAID scores was seen. The results and moderate to large effects sizes suggest that PaQ device use has beneficial and clinically relevant effects to overcoming barriers to and negative appraisal of insulin treatment, without increasing other diabetes-related distress. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: The ability of patients to achieve glycemic control depends in part on their ability to interpret and act on blood glucose (BG) results. This clinical study was conducted to determine if a simple on-meter color range indicator (CRI) could improve the ability of patients to categorize BG values into low, in-range, and high glycemic ranges. The clinical study was conducted in 59 subjects with type 2 diabetes (T2DM). Subjects classified 50 general, 15 before- and 15 after-meal BG values as low, in-range, or high based on their current knowledge. Subjects then interactively experienced the on-meter CRI, which showed whether alternate BG values were low, in-range, or high. After CRI interaction, subjects repeated the original scoring assessment followed by a survey exploring their awareness of glucose ranges. Following interaction with the CRI, subjects improved their ability to categorize general, before-meal and after-meal BG results by 23.4% ± 3.0% (SEM), 14.2% ± 2.4%, and 16.1% ± 2.9%, respectively (all P < .001), into low, in-range, and high glycemic ranges. Improvement was not accompanied by an increase in time spent categorizing results. There was no correlation between subject HbA1c, test frequency, or duration of diabetes and ability to correctly classify results. Subjects agreed the CRI feature helped them easily interpret glucose values and improved their awareness of glucose ranges. A short interactive session with a meter including a CRI feature improved the ability of T2DM subjects to interpret and categorize BG values into recommended ranges. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: Oxidative stress is a detrimental feature of diabetes implicated in the progression of the disease and its complications. The relationship between insulin therapy and oxidative stress is complex. This study tested the hypothesis that improved glucose control, rather than insulin dose, is central to reduced oxidative stress in patients with type 2 diabetes following continuous subcutaneous insulin infusion (CSII). In this 16-week, multicenter study, 54 CSII-naïve patients with type 2 diabetes (age 57 ± 10 years, HbA1c 69 ± 15 mmol/mol [8.5 ± 1.4%], diabetes duration 13 ± 6 years) treated with either oral antidiabetic agents (OAD) alone (n = 17), basal insulin ± OAD (n = 17), or multiple daily injections (MDI) ± OAD (n = 20) were the evaluable group. Diabetes medications except metformin were discontinued, and 16 weeks of CSII was initiated. Insulin dose was titrated to achieve optimal glycemic control. A plasma marker of oxidative stress relevant to cardiovascular disease (oxidized low density lipoprotein [ox-LDL]) was assessed at baseline and week 16. CSII improved glycemic control (HbA1c -13 ± 2 mmol/mol [-1.2 ± 0.2%]; fasting glucose -36.6 ± 8.4 mg/dL; mean glucose excursion -23.2 ± 6.5 mg/dL, mean ± SE; all P < .001) and reduced ox-LDL (-10.5%; P < .05). The antioxidant effect was cohort-independent (P > .05), but was significantly more pronounced in patients on statins (P = .019). The effect of CSII was more closely correlated to improvements in glucose excursion (P = .013) than to insulin dose (P > .05) or reduction in HbA1c (P > .05). CSII induces depression of plasma ox-LDL associated with change in glucose control, rather than with change in insulin dose. The effect is augmented in patients receiving statins. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 02/2015;
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    ABSTRACT: The functional performance of the JuniorSTAR(®) (Sanofi, Paris, France) half-unit insulin pen was evaluated through a series of specific objective tests to assess the dose accuracy, pen weight, injection force, and dialing torque. Pens (n = 60) were tested under standard atmospheric conditions with 3 different types of insulins manufactured by Sanofi (insulin glargine, insulin glulisine, and biphasic insulin isophane). The dose accuracy was tested according to the ISO 11608-1:2012 standards. Injection doses of 0.010, 0.155, and 0.300 ml were evaluated. For mean weight evaluation, the pens without the cartridge were weighed on precision balances. The injection force was measured using a texture analyzer and the dialing torque was measured using a torque meter. JuniorSTAR met the ISO 11608-1:2012 criteria for dose accuracy as all the delivered doses were within the predefined limits for all types of insulin tested. The mean weight of the JuniorSTAR pen was 33.4 g (SD = 0.075). The mean injection force was 6.0 N (SD = 0.8), 4.3 N (SD = 0.4), and 5.1 N (SD = 0.6) for insulin glargine, insulin glulisine, and biphasic insulin isophane, respectively. The mean dialing torque was 5.09 Ncm (SD = 0.29) and 5.88 Ncm (SD = 0.53) for setting and correcting a dose, respectively. Together with results from a previously reported usability survey, these results show that the JuniorSTAR reusable, half-unit pen is a lightweight and accurate device for insulin delivery with a dialing torque and injection force suitable for young people with type 1 diabetes. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 01/2015;
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    ABSTRACT: ARKRAY, Inc developed the world's first automatic glycohemoglobin analyzer based on HPLC (1981). After that, ARKRAY developed enzymatic HbA1c assay "CinQ HbA1c" with the spread and diversification of HbA1c measurement (2007). CinQ HbA1c is the kit of Clinical Chemistry Analyzer, which uses fructosyl peptide oxidase (FPOX) for a measurement reaction. This report mainly indicates the developmental background, measurement principle, and future of the enzymatic method HbA1c reagent. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 01/2015;
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    ABSTRACT: Research advances in biochemical molecules have led to the development of convenient and reproducible biosensing molecules for glycated proteins, such as those based on the enzymes fructosyl amino acid oxidase (FAOX) or fructosyl peptide oxidase (FPOX). Recently, more attractive biosensing molecules with potential applications in next-generation biosensing of glycated proteins have been aggressively reported. We review 2 such molecules, fructosamine 6-kinase (FN6K) and fructosyl amino acid-binding protein, as well as their recent applications in the development of glycated protein biosensing systems. Research on FN6K and fructosyl amino acid-binding protein has been opening up new possibilities for the development of highly sensitive and proteolytic-digestion-free biosensing systems for glycated proteins. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 01/2015;
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    ABSTRACT: The measuring method for glycated albumin (GA) has been developed as a new glycemic control marker since the beginning of the 21st century. Since GA has an advantage in reflecting glycemic status over a shorter period than hemoglobin A1c (HbA1c), much research and many reviews have been reported. However, so far there have been few reports on glycation sites based on the tertiary structure of human serum albumin (HSA) and the comparison of glycation rates between GA and HbA1c in detail. The present review discusses how the glycation sites of lysine residues in HSA are modified with glucose, whereas the glycation sites of lysine residues are located inside of HSA as well as the direct comparison of glycation rates between GA and HbA1c using human blood. Moreover, the most recent clinical researches on GA are described. © 2015 Diabetes Technology Society.
    Journal of diabetes science and technology 01/2015;