Journal of diabetes science and technology

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  • ISSN
    1932-2968

Publications in this journal

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    ABSTRACT: We have previously tested, in a laboratory setting, a novel algorithm that enables prediction of hypoglycemia. The algorithm integrates information of autonomic modulation, based on heart rate variability (HRV), and data based on a continuous glucose monitoring (CGM) device. Now, we investigate whether the algorithm is suitable for prediction of hypoglycemia and for improvement of hypoglycemic detection during normal daily activities. Twenty-one adults (13 men) with T1D prone to hypoglycemia were recruited and monitored with CGM and a Holter device while they performed normal daily activities. We used our developed algorithm (a pattern classification method) to predict spontaneous hypoglycemia based on CGM and HRV. We compared 3 different models; (i) a model containing raw data from the CGM device; (ii) a CGM* model containing data derived from the CGM device signal; and (iii) a CGM+HRV model-combining model (ii) with HRV data. A total of 12 hypoglycemic events (glucose levels < 3.9 mmol/L, 70 mg/dL) and 237 euglycemic measurements were included. For a 20-minute prediction, model (i) resulted in a ROC AUC of 0.69. If a high sensitivity of 100% was chosen, the corresponding specificity was 69%. (ii) The CGM* model yielded a ROC AUC of 0.92 with a corresponding sensitivity of 100% and specificity of 71%. (iii) The CGM+HRV model yielded a ROC AUC of 0.96 with a corresponding sensitivity of 100% and specificity of 91%. Data shows that adding information of autonomic modulation to CGM measurements enables prediction and improves the detection of hypoglycemia.
    Journal of diabetes science and technology 09/2014;
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    ABSTRACT: The purpose was to characterize participants' experiences of a diabetes self-management (DSM) education program delivered via a virtual world (VW) versus a face-to-face (F2F) format. Participants included a randomly selected sample of participants who completed the Women in Control study. Four focus groups were conducted with 32 participants. Four researchers coded the data and conducted a qualitative thematic analysis. Four overarching themes were identified. Three domains apply to both VW and F2F formats, including (1) the value of DSM knowledge gained, (2) cultivating DSM attitudes and skills, and (3) the value of peer-derived social support. The fourth domain is labeled positive technological development for DSM (VW condition only). VW and F2F groups both reported mastery of DSM knowledge, attitudes, and skills, and there were no differences in peer-derived social support between groups. The technological aspects of VW participation afforded VW participants a unique sense of personal agency and diabetes self-efficacy not reported by F2F participants. DSM education in a VW is feasible and educational outcomes are similar to a F2F classroom experience. Furthermore, learning DSM skills in a VW offers unique advantages in supporting personal agency for health behavior change. Further research is warranted.
    Journal of diabetes science and technology 09/2014;
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    ABSTRACT: Although test strips for self-monitoring of blood glucose (SMBG) represent around 50% of diabetes treatment cost in Argentina, little is known about their current use and relationship with different types of treatment. We therefore aimed to estimate the current use of test strips and identify the major use drivers and the percentage they represent of total prescription costs in 2 entities of the social security system (SSS) of Argentina. Observational retrospective study measuring test strip prescriptions delivered by pharmacies from the province of Buenos Aires (8115 records collected during 3 months provided by the Colegio de Farmacéuticos de la Provincia de Buenos Aires) of affiliates with type 2 diabetes (T2DM) from 2 large entities of the SSS system. The average monthly test strips/patient used for SMBG was 97.5 ± 70.1. This number varied according to treatment: monotherapy with oral antidiabetic drugs (OAD) < combined OAD therapy < insulin treatment. Test strips represented a higher percentage of the total prescription cost in people under OAD monotherapy (84.6%) and lower in those with insulin analogs (46.9%). In our population, the type of hyperglycemia treatment was the main driver of test strip use for SMBG and its impact on the total prescription cost depends on the kind of such treatment. Since it has been shown that patients' education and prescription audit can optimize test strip use and treatment outcomes, implementation of such strategies could appropriately support, optimize, and reduce ineffective test strip use in people with T2DM.
    Journal of diabetes science and technology 09/2014;
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    ABSTRACT: Continuous glucose monitoring (CGM) and automated insulin delivery may make diabetes management substantially easier, if the quality of the resulting therapy remains adequate. In this study, a semi-closed-loop control algorithm was used to drive insulin therapy and its quality was compared to that of subject-directed therapy. Twelve subjects stayed at the study site for approximately 70 hours and were provided with the investigational Automated Pancreas System Test Stand (APS-TS), which was used to calculate insulin dosage recommendations automatically. These recommendations were based on microdialysis CGM values and common diabetes therapy parameters. For the first half of their stay, the subjects directed their diabetes therapy themselves, whereas for the second half, the insulin recommendations were delivered by the APS-TS (so-called algorithm-driven therapy). During subject-directed therapy, the mean glucose was 114 mg/dl compared to 125 mg/dl during algorithm-driven therapy. Time in target (90 to 150 mg/dl) was approximately 46% during subject-directed therapy and approximately 58% during algorithm-driven therapy. When subjects directed their therapy, approximately 2 times more hypoglycemia interventions (oral administration of carbohydrates) were required than during algorithm-driven therapy. No hyperglycemia interventions (delivery of addition insulin) were necessary during subject-directed therapy, while during algorithm-driven therapy, 2 hyperglycemia interventions were necessary. The APS-TS was able to adequately control glucose concentrations in the subjects. Time in target was at least comparable or moderately higher during closed-loop control and markedly fewer hypoglycemia interventions were required, thus increasing patient safety.
    Journal of diabetes science and technology 09/2014;
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    ABSTRACT: We analyzed the pretransplant continuous glucose monitoring (CGM) data of 45 patients that underwent total pancreatectomy followed by autologous islet transplantation (AIT) at the University of Arizona Medical Center. Traditional and novel metrics of CGM time series were correlated to the total islet count (TIC), islet equivalents (IEQs), and weight-normalized IEQs (IEQ/kg). In a subset cohort (n = 26) we analyzed the relationship among the infused number of islets, the CGM indicators, and the first recorded insulin requirement after the procedure. We conclude that receiving a high islet yield is sufficient yet not necessary to achieve low or null insulin requirements within the first 50 days after surgery. Furthermore, CGM inertia and CGM length of curve (2 novel CGM indicators) are shown to be correlated to islet yield, and the CGMs normalized area (Ao) and time ratio above hyperglycemic level (To) are strongly correlated to insulin requirement. A screening test based on To is shown to have 100% sensitivity and 88% specificity discriminating insulin independence upon discharge.
    Journal of diabetes science and technology 09/2014;
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    ABSTRACT: Severe hypoglycemia (SH) is a common problem in type 1 diabetes (T1D). Annually, nearly 1 of 5 persons with long-standing T1D will have SH. Though injections of glucagon are effective in treating SH, liquid formulations of glucagon are biochemically very unstable. For this reason, available preparations of glucagon are lyophilized; the powder and the diluent must be mixed at the point of care prior to administration and any remaining drug must be discarded. The process of mixing and delivery is complex. Coupled with the emotional stress of the caregiver, errors in glucagon delivery are very common. For these reasons, workers at Enject, Inc are in the process of developing a device that addresses the shortcomings of this currently approved method of glucagon delivery. The Enject device will store the glucagon powder and the diluent in separate compartments and will rapidly mix and inject the components only upon activation of the pen at the point of care.
    Journal of diabetes science and technology 09/2014;
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    ABSTRACT: Galactomannan is an insoluble polysaccharide that has been shown to reduce postprandial excursions. We assessed the impact of a novel galactomannan derivative (PAZ320) on the magnitude of 2-hour postprandial glucose excursions in individuals with type 2 diabetes who were being treated with oral medication and/or insulin. Investigators recently reported findings from a single-center, open-label, prospective study that evaluated the efficacy of PAZ320 in 24 subjects with type 2 diabetes who were treated with oral antidiabetic agents and/or insulin. End points included adverse events and area under the curve during 3-hour postprandial glucose excursion (gAUC). Subjects consumed a test meal without PAZ320 at baseline and then ingested low-dose (8 g) and high-dose (16 g) PAZ320 with test meals at subsequent intervention visits. A post hoc analysis was conducted to determine changes in 2-hour postprandial glucose excursions. Among the 20 subjects for whom data were available for all clinic visit test meals, 15 (75%) responded to low-dose, high-dose, or both medication dosages. Low-dose responders (n = 8) experienced clinically significant improvements in 2-hour postprandial glucose excursions from baseline excursions compared with nonresponders (-28.00 ± 25.97 mg/dL vs 23.42 ± 11.45 mg/dL, P = .005). Similar differences were seen in high-dose responders (-28.82 ± 24.26 vs 33.89 ± 20.56 mg/dL, P < .0001). PAZ320 was shown to be safe in all patients studied and effective in controlling postprandial glucose in a large portion of the study population. Additional studies are needed to determine its long-term effects on HbA1c and to further define which subpopulation(s) may respond to PAZ320 therapy.
    Journal of diabetes science and technology 09/2014; 8(5):1018-22.
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    ABSTRACT: Adolescents and young adults use text messaging as their primary mode of communication, thus providing an opportunity to use this mode of communication for mobile health (mHealth) interventions. Youth with diabetes are an important group for these mHealth initiatives, as diabetes management requires an enormous amount of daily effort and this population has difficulty achieving optimal diabetes management. Goal setting and self-efficacy are 2 factors in the management of diabetes. We examined the feasibility of a healthy lifestyle text messaging program targeting self-efficacy and goal setting among adolescents and young adults with diabetes. Participants, ages 16-21, were assigned to either a text messaging group, which received daily motivational messages about nutrition and physical activity, or a control group, which received paper-based information about healthy lifestyle. Both groups set goals for nutrition and physical activity and completed a measure of self-efficacy. Participants' mean age was 18.7 ± 1.6 years old, with diabetes duration of 10.0 ± 4.6 years, and A1c of 8.7 ± 1.7%. The text messaging intervention was rated highly and proved to be acceptable to participants. Self-efficacy, glycemic control, and body mass index did not change over the course of the short, 1-month pilot study. Positive, daily, motivational text messages may be effective in increasing motivation for small goal changes in the areas of nutrition and physical activity. These interventions may be used in the future in youth with diabetes to improve diabetes care. Utilizing more targeted text messages is an area for future research.
    Journal of diabetes science and technology 09/2014; 8(5):1029-34.
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    ABSTRACT: If a biosimilar insulin is discovered postmarketing to be subpotent, superpotent, or contaminated or the contents mislabeled, it is an adulterated product and must be quarantined for removal including from a patient's home. Adulterated products could be considered "counterfeit" since they do not meet the original standards established by the FDA. The FDA must establish a method of regularly assaying samples of biosimilar insulin drawn directly from the supply pipeline to help ensure patient safety and evaluate clinical performance. Independent groups without conflict of interest would perform confidential comparison assay. For less than 5 cents per vial/pen, manufacturers could easily support an independent, FDA-recognized, random sample program and create a functional postmarket surveillance system that better protects the public and the manufacturer from undesired outcomes.
    Journal of diabetes science and technology 09/2014; 8(5):1052-4.
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    ABSTRACT: Automated blood glucose (BG) and insulin pump systems allow wireless transmission of all BG readings to a user's pump. This study aimed to assess whether use of such a system, as compared with a manual BG entry insulin pump, resulted in higher mean daily frequency of BGs recorded after 6 months. A 12-month randomized crossover trial, comprising 2 phases, was conducted. All participants used insulin pump devices with automated vs manual BG entry for 6 months each; order of system use was randomly assigned. Device interactions were assessed from pump and glucometer downloads. Thirty-five participants were enrolled; 9 withdrew during the study. Use of the automated insulin pump system resulted in higher mean daily BG recorded over 6 months of use when compared to a manual BG entry system (5.8 ± 1.7 vs 5.0 ± 1.9; P = .02 [95% confidence interval, 0.14 to 1.58]). Bolus frequency was similar between groups. No HbA1c difference was observed between groups at 6 months (8.0% [64 mmol/l] ± 1.3 automated vs 7.7% [61 mmol/l] ± 0.9 manual; P = .38). Post hoc analysis demonstrated improved ΔHbA1c with automated system use in an adolescent subgroup with suboptimal baseline BG frequency (-0.9% vs + 0.5%; P = .003). Use of an automated glucometer/insulin pump resulted in higher number of BGs recorded over 6 months when compared to an insulin pump with manual BG entry. This may be especially beneficial for adolescent manual system users who enter <5 BGs per day into their pump.
    Journal of diabetes science and technology 09/2014; 8(5):998-1004.
  • Journal of diabetes science and technology 09/2014; 8(5):1048-51.
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    ABSTRACT: Computerized insulin infusion protocols have facilitated more effective blood glucose (BG) control in intensive care units (ICUs). This is particularly important in light of the risks associated with hypoglycemia. End stage renal disease (ESRD) increases the risk of insulin-induced hypoglycemia. We evaluated BG control in 210 patients in 2 medical ICUs and in 2 surgical ICUs who were treated with a computerized insulin infusion program (CIIP). Our CIIP was programmed for a BG target of 140-180 mg/dL for medical ICU patients or 120-160 mg/dL for surgical ICU patients. In addition, we focused on BG control in the 11% of our patients with ESRD. Mean BG was 147 ± 20 mg/dL for surgical ICU patients and 171 ± 26 mg/dL for medical ICU patients. Of both surgical and medical ICU patients, 17% had 1 or more BG 60-79 mg/dL, while 3% of surgical ICU and 8% of medical ICU patients had 1 or more BG < 60 mg/dL. Mean BG in ESRD patients was 147 ± 16 mg/dL similar to 152 ± 23 mg/dL in patients without ESRD. Of ESRD patients, 41% had 1 or more BG < 79 mg/dL as compared with 17.8% of non-ESRD patients (P < .01). A higher BG target for medical ICU patients as compared with surgical ICU patients yielded comparably low rates of moderate or severe hypoglycemia. However, hypoglycemia among ESRD patients was more common compared to non-ESRD patients, suggesting a need for a higher BG target specific to ESRD patients.
    Journal of diabetes science and technology 09/2014; 8(5):923-9.
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    ABSTRACT: A widely used method in monitoring glycemic status of ICU patients is point-of-care (POC) monitoring devices. A possible limitation to this method is altered peripheral blood flow in patients in shock, which may result in over/underestimations of their true glycemic status. This study aims to determine the accuracy of blood glucose measurements with a POC meter compared to laboratory methods in critically ill patients in shock. POC blood glucose was measured with a glucose-1-dehydrogenase-based reflectometric meter. The reference method was venous plasma glucose measured by a clinical chemistry analyzer (glucose oxidase-based). Outcomes assessed were concordance to ISO 15197:2003 minimum accuracy criteria for glucose meters, bias in glucose measurements obtained by the 2 methods using Bland-Altman analysis, and clinical accuracy through modified error grid analysis. A total of 186 paired glucose measurements were obtained. ISO 2003 accuracy criteria were met in 95.7% and 79.8% of POC glucose values in the normotensive and hypotensive group, respectively. Mean bias for the normotensive group was -12.4 mg/dL, while mean bias in the hypotensive group was -34.9 mg/dL. POC glucose measurements within the target zone for clinical accuracy were 90.2% and 79.8% for the normotensive and hypotensive group, respectively. POC blood glucose measurements were significantly less accurate in the hypotensive subgroup of ICU patients compared to the normotensive group. We recommend a lower threshold in confirming POC blood glucose with a central laboratory method if clinically incompatible. In light of recently updated accuracy standards, we also recommend alternative methods of glucose monitoring for the ICU population as a whole regardless of blood pressure status.
    Journal of diabetes science and technology 09/2014; 8(5):937-44.
  • Journal of diabetes science and technology 09/2014; 8(5):915-7.
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    ABSTRACT: This article reviews the concept of using the proper methods for the proper task, in this case measuring dose-to-dose accuracy of continuous subcutaneous insulin infusion pumps.
    Journal of diabetes science and technology 08/2014;
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    ABSTRACT: Type 1 diabetes is a common chronic disease of childhood and one of the most difficult conditions to manage. Advances in insulin formulations and insulin delivery devices have markedly improved the ability to achieve normal glucose homeostasis. However, hypoglycemia remains the primary limiting factor in achieving normoglycemia and is a frequent complication in children with acute gastroenteritis and/or poor oral intake. In situations of impaired carbohydrate intake or absorption, glucagon therapy is the only out-of-hospital treatment option available to families and caregivers. Glucagon is recommended for the treatment of severe hypoglycemia and rapidly increases blood glucose by increasing hepatic glucose production from glycogenolysis. Mini-dose glucagon is a widely utilized off-label treatment for managing mild or impending hypoglycemia and is administered as a small subcutaneous injection. It was initially described for use in children who were unable to tolerate or absorb oral carbohydrates but not in need of advanced medical care. Yet, mini-dose glucagon may be useful in any individual with relative insulin excess. The regimen aims to prevent severe hypoglycemic episodes and is safe, effective, and easily administered by patients and caregivers in the out-of-hospital setting. By empowering patients and their families, this important tool could help to alleviate the physical, psychosocial, and financial burden evolving from impending hypoglycemia.
    Journal of diabetes science and technology 08/2014;
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    ABSTRACT: The concept of bioreactors in biochemical engineering is a well-established process; however, the idea of applying bioreactor technology to biomedical and tissue engineering issues is relatively novel and has been rapidly accepted as a culture model. Tissue engineers have developed and adapted various types of bioreactors in which to culture many different cell types and therapies addressing several diseases, including diabetes mellitus types 1 and 2. With a rising world of bioreactor development and an ever increasing diagnosis rate of diabetes, this review aims to highlight bioreactor history and emerging bioreactor technologies used for diabetes-related cell culture and therapies.
    Journal of diabetes science and technology 08/2014;
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    ABSTRACT: Utilizing endogenous molecules as a therapeutic approach is almost unequivocally superior to engineered or synthetic molecules. However, one rarely encounters an anti-inflammatory, cytoprotective, immunomodulatory and wound-healing molecule that has been available for use for decades. α1-antitrypsin (AAT), a circulating protein that rises more than 4-fold during acute-phase responses, has been administered for a rare genetic deficiency at large doses, for life. Aside from advances in insulin therapy, medical research in type 1 diabetes (T1D) has predominantly focused on autoimmunity-controlling the adaptive immune response. However, it is now appreciated that one may need to extend therapeutic targets to incorporate immune responses to cellular injury, as well as promote selective control over excessive inflammation and early tissue repair. Recent data suggest that tissue damage related to lung and renal ischemia-reperfusion injury, stroke, and ischemic heart disease is markedly reduced by AAT. AAT was also shown to protect pancreatic islet β cells at multiple levels. Unlike classic immunosuppressive and anti-inflammatory approaches, AAT exerts some antiviral and antibacterial activities. Based on these and other reports, AAT is under evaluation for treatment of T1D patients in multiple clinical trials. Initial results suggest that AAT therapy could potentially improve insulin production without adverse effects. Up to 50% of individuals displayed improved islet function. It is a rare occurrence in T1D research that a therapy is offered that holds a safety profile equal or superior to that of insulin alone. While placebo-controlled trials are ongoing, the mechanism(s) behind these favorable activities of AAT are still being explored.
    Journal of diabetes science and technology 08/2014;
  • Journal of diabetes science and technology 08/2014;
  • Journal of diabetes science and technology 08/2014;

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