CGParkin Communications Inc.

Las Vegas, NV, United States

CGParkin Communications Inc.

Las Vegas, NV, United States
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Parkin C.G.,CGParkin Communications Inc.
Journal of Diabetes Science and Technology | Year: 2017

A recent study by the National Minority Quality Forum (NMQF) reported the failures and adverse health outcomes of the Medicare competitive bidding program as implemented by the Centers for Medicare & Medicaid Services (CMS) in 2011. CMS has repeatedly reported that the program caused no disruption of beneficiary access to needed medical products (including diabetes testing supplies) and that no adverse outcomes occurred. Although signals of disruption were seen early in the program implementation, economic modeling by McGeary and Katzman in 2004 demonstrated that the program design was significantly flawed. This article discusses the unintended consequences of competitive bidding program and provides a rationale for suspending the program until CMS can implement effective monitoring protocols to protect the safety of Medicare beneficiaries. © 2016 Diabetes Technology Society.

Parkin C.G.,CGParkin Communications Inc.
Journal of Diabetes Science and Technology | Year: 2017

In this issue of Journal of Diabetes Science and Technology, Christiansen and colleagues report results from two studies, laboratory and clinical, that assessed the accuracy of a new blood glucose monitoring system, the Contour®Next ONE (Ascensia Diabetes Care, Parsippany, NJ, USA). The new system comprises a blood glucose meter that can link (via Bluetooth®) to the Contour™ Diabetes app, which operates on a smartphone or tablet. Results from both studies showed that the system exceeded the accuracy standards defined by the International Organization for Standardization (ISO) 15197:2013. It is worrisome, however, that many FDA-cleared (and marketed) blood glucose monitoring systems do not meet ISO accuracy criteria. Significant improvements in regulatory oversight and enforcement are needed. © Diabetes Technology Society.

Schnell O.,Helmholtz Center Munich | Amann-Zalan I.,Hoffmann-La Roche | Jelsovsky Z.,Biostat International Inc. | Moritz A.,Hoffmann-La Roche | And 5 more authors.
Diabetes Care | Year: 2013

OBJECTIVE-The effect of therapeutic strategies on cardiovascular (CV) disease can be evaluated by monitoring changes in CV risk biomarkers. This study investigated the effect of a structured self-monitoring of blood glucose (SMBG) protocol and the resulting improvements in glycemic control on changes in high-sensitivity C-reactive protein (hs-CRP) in insulin-naïve patients with type 2 diabetes. RESEARCH DESIGN ANDMETHODS-The Structured Testing Program (STeP) study was a prospective, cluster-randomized, multicenter trial in which 483 poorly controlled, insulinnaïve patientswith type 2 diabetes were randomized to active control (ACG) or structured testing (STG) that included quarterly structured SMBG. Changes in A1C, hs-CRP, and glycemic variability (STG subjects only) were measured at baseline and quarterly. RESULTS-Reductions in geometric mean hs-CRP values were significantly greater in the STG group at months 3 (P = 0.005), 6 (P = 0.0003), and 12 (P = 0.04) than in the ACG group. STG patients at high CV risk (>3mg/L) showed significantly greater reductions in hs-CRP levels than ACG patients at high CV risk: 23.64 mg/dL (95% CI 24.21 to 23.06) versus 22.18 mg/dL (22.93 to21.43), respectively (P = 0.002). There was a strong correlation between reductions in hs-CRP and A1C in both groups: standardized coefficient (β) was 0.25 for the entire cohort (P< 0.0001), 0.31 for STG (P < 0.0001), and 0.16 for ACG (P = 0.02). CONCLUSIONS- Reductions in hs-CRP level are associated with reductions in A1C but not reductions in lipids or glycemic variability. Comprehensive structured SMBG-based interventions that lower A1C may translate into improvements in CV risk, as evidenced by levels of the biomarker hs-CRP. © 2013 by the American Diabetes Association.

Pozzilli P.,Biomedical University of Rome | Raskin P.,Southwestern Medical Center at Dallas | Parkin C.G.,CGParkin Communications Inc.
Diabetes, Obesity and Metabolism | Year: 2010

Large clinical trials have shown that improving glycaemic control significantly reduces the risk of long-term microvascular complications in type 1 (T1DM) and type 2 (T2DM) diabetes. Achieving optimal glycaemic control often requires the use of multiple daily insulin injections. Current approaches to insulin administration are less than optimal; many T2DM patients view insulin therapy as inconvenient and uncomfortable and may delay starting insulin therapy because of this. A new oral insulin spray formulation and delivery system provides an alternative to injectable and inhaled insulin. The system allows a liquid oral spray insulin formulation to be delivered into the mouth via an aerosolized spray. The oral insulin spray is a tasteless liquid aerosol mist formulation that is administered to the buccal mucosa using a proprietary delivery system. The active pharmaceutical ingredient is recombinant human insulin; however, the formulation behaves in a fashion more similar to the synthetic fast-acting insulin analogues. In clinical studies of healthy subjects and subjects with T1DM and T2DM, investigators have shown that the oral insulin spray was absorbed in direct relation to the amount given and had a faster onset and a shorter duration of action when compared with regular insulin given subcutaneously. In all of the studies conducted, the oral insulin spray was generally well tolerated. Some healthy individuals and subjects with T1DM experienced transient (1-2 min) mild dizziness during dosing; these symptoms were mild and self-limited. No changes in vital signs, laboratory values or physical examination results were noted. The ease of use of the insulin spray formulation may increase patient acceptance and treatment compliance, thereby potentially reducing complications and improving quality of life for patients with insulin-dependent diabetes. This article provides an overview of the safety profile and proposed mechanism of action of this insulin formulation and presents findings from trials which studied its effects in subjects with T1DM and T2DM. © 2009 Blackwell Publishing Ltd.

Barnard K.,University of Southampton | Parkin C.,CGParkin Communications Inc. | Young A.,University of Southampton | Ashraf M.,Hoffmann-La Roche
Journal of Diabetes Science and Technology | Year: 2012

Background: Many patients do not intensify their insulin regimens. It is believed that lack of adherence may be largely due to fear of hypoglycemia. We hypothesized that utilization of an automated bolus calculator (bolus advisor) might reduce fear of hypoglycemia and encourage patients to achieve improved glycemic control. Method: We surveyed 1,412 type 1 diabetes mellitus (T1DM) patients treated with multiple daily insulin injection therapy at 270 hospitals in the United Kingdom and Republic of Ireland to assess their attitudes and behaviors regarding insulin therapy after use of a bolus advisor (Accu-Chek ® Aviva Expert blood glucose meter and bolus advisor system, Roche Diagnostics). The device automatically calculates bolus dosages based on current blood glucose values, anticipated meal intake, and other parameters. Results: Five hundred eighty-eight T1DM patients responded to the survey. Respondents were predominantly female, age <1 to 70 years, with diabetes duration of <1 to >15 years. Respondents had 4-12 weeks prior experience using the bolus advisor. 76.7% of respondents indicated current bolus advisor use to calculate insulin boluses for meals/snacks always or quite often. 52.0% of respondents indicated that fear of hypoglycemia was reduced (39.0%) or significantly reduced (13.0%). 78.8% indicated that confidence in the insulin dose calculation improved (50.8%) or significantly improved (28.0%). 89.3% indicated that the bolus advisor made bolus calculation easy or very easy compared with manual calculation. Conclusions: Most patients felt that using the bolus advisor was easier than manual bolus calculation, improved their confidence in the accuracy of their bolus dosage, and reduced their fear of hypoglycemia. Randomized trials are needed to confirm these perceptions and determine whether bolus advisor use improves clinical outcomes. © Diabetes Technology Society.

Parkin C.G.,CGParkin Communications Inc. | Buskirk A.,ALBuskirk LLC | Hinnen D.A.,Mid America Diabetes Associates | Axel-Schweitzer M.,Hoffmann-La Roche
Diabetes Research and Clinical Practice | Year: 2012

Self-monitoring of blood glucose (SMBG) is one component of diabetes management. SMBG presents information about current glycemic status and provides the ability to obtain immediate feedback regarding the impact of behavioral and pharmacological interventions on glucose levels. However, SMBG is useful only when the glucose information is understood correctly, data are accurately interpreted, and results prompt appropriate therapeutic actions.The International Diabetes Federation (IDF) recently published guidelines for SMBG use in non-insulin treated people with diabetes, recommending that SMBG should be used only when patients and/or their clinicians possess the ability and willingness to incorporate SMBG monitoring and therapy adjustment into their diabetes care plan. If SMBG is used, the IDF also recommends that structured SMBG be performed utilizing defined regimens to meet individual needs.Structured SMBG can be performed as daily glucose profiles that are representative of daily glucose excursions. Measuring preprandial/postprandial blood glucose (bG) levels on consecutive or alternating days (" testing in pairs" ) also provides impactful glucose information for daily diabetes management.This article reviews recent studies that appropriately utilized structured SMBG as an integral component of comprehensive diabetes management and discusses how their findings support the IDF recommendations. Our goal is to help clinicians make more informed decisions about the value and utility of SMBG in diabetes management. © 2012 Elsevier Ireland Ltd.

Brazg R.L.,Rainier Clinical Research Center | Klaff L.J.,Rainier Clinical Research Center | Parkin C.G.,CGParkin Communications Inc.
Journal of Diabetes Science and Technology | Year: 2013

Background: Blood glucose data are frequently used in clinical decision making, thus it is critical that self-monitoring of blood glucose (SMBG) systems consistently provide accurate results. Concerns about SMBG accuracy have prompted the development of newly proposed International Organization for Standardization (ISO) standards: ≥95% of individual glucose results shall fall within ±15 mg/dl of the results of the manufacturer's reference procedure at glucose concentrations <100 mg/dl and within ±15% for values ≥100 mg/dl. We evaluated seven marketed systems against the current and proposed ISO criteria (criterion A). Method: Capillary blood samples were collected from 100 subjects and tested on seven systems: Accu-Chek Aviva Plus, Advocate Redi-Code, Element, Embrace, Prodigy Voice, TRUEbalance, and WaveSense Presto. Results were compared with manufacturer's documented reference system, YSI or perchloric acid hexokinase; three different strip lots from each system were tested on each subject, in duplicate. Results: Compared against current ISO criteria (≥95% within ±15 mg/dl for values <75 mg/dl and ±20% for values ≥75 mg/dl) the Accu-Chek Aviva Plus, Element, and WaveSense Presto systems met accuracy criteria. However, only the Accu-Chek Aviva Plus met the proposed ISO criteria (criterion A) in all three lots. The other six systems failed to meet the criteria in at least two of the three lots, showing lot-to-lot variability, high/low bias, and variations due to hematocrit. Conclusions: Inaccurate SMBG readings can potentially adversely impact clinical decision making and outcomes. Clinicians can reduce controllable variables by prescribing accurate SMBG systems. Adherence to the proposed ISO criteria should enhance patient safety by improving the accuracy of SMBG systems. © Diabetes Technology Society.

Unger J.,Catalina Research Institute | Parkin C.G.,CGParkin Communications Inc.
Postgraduate Medicine | Year: 2010

Type 2 diabetes mellitus is a complicated metabolic disease affecting millions of individuals worldwide. The medications used to manage the disease are based on different pharmacologic approaches, including decreasing hepatic gluconeogenesis, stimulating pancreatic insulin production, slowing polysaccharide digestion, and increasing insulin sensitivity in muscle, liver, and fat to lower blood glucose. Incretin-based therapies, including glucagon-like peptide-1 (GLP-1) receptor agonists, mimic the effects of native GLP-1, while dipeptidyl peptidase-4 inhibitors increase circulating concentrations of endogenous GLP-1. This review focuses on means by which primary care physicians might evaluate the utility of pharmacologic agents based on their relation to the pathogenesis of type 2 diabetes. In general, patients with type 2 diabetes should be treated to their lowest targeted glycemic goals as soon as they are diagnosed, for as long as possible, as safely as possible, and as rationally as possible. © Postgraduate Medicine.

In this issue of Journal of Diabetes Science and Technology, Grady and coauthors enrolled 101 patients with type 1 and type 2 diabetes to evaluate new technology incorporated into the LifeScan VerioPro and VerioIQ blood glucose meters. The "pattern detection" software provides real-time, onscreen messages that alert users to patterns of high glucose (fasting and premeal) and low glucose as they are detected. The study showed that most participants possess a good understanding of the factors that can cause hyperglycemia; however, their understanding of the causes of hypoglycemia events was not as strong. Nevertheless, more than 70% of participants indicated they preferred to use a blood glucose meter that provides pattern detection capability. Although not designed to assess the impact of the pattern detection tool on clinical outcomes, the study highlights the value of continuous innovation in self-monitoring of blood glucose (SMBG) technology among manufacturers. Unfortunately, many patients may never have access to these systems due to reductions in Medicare reimbursement. Instead, they may be forced to use SMBG systems that are inaccurate and provide inadequate patient support. Stronger regulatory requirements are needed to ensure that all SMBG systems marketed to patients are accurate, reliable, and supported by adequate patient training, and current health care reimbursement policies should be restructured to encourage manufacturers to continue their eforts to develop innovative technology to further improve the utility and usability of their SMBG systems. © Diabetes Technology Society.

Edelman S.,University of California at San Diego | Polonsky W.H.,University of California at San Diego | Parkin C.G.,CGParkin Communications Inc.
Current Medical Research and Opinion | Year: 2014

Background: Many branded analog insulins will lose patent protection during the next few years. In response, a number of companies are developing biosimilar insulins, which have the potential to lower healthcare costs and increase patient access. Although these products are not yet available in the US, it is important that patients, payers and clinicians be aware of the potential benefits as well as concerns associated with biosimilar insulins. Scope: This report provides information about these new products and discusses key questions clinicians should consider regarding biosimilar insulin. Conclusion: The biosimilar insulins being developed have the potential to provide clinical benefits that are similar to current insulin analogs at a more affordable price, thereby allowing more patients greater access to these effective therapies. However, industry and regulatory agencies must proceed with caution in bringing these new insulins to market. Clinicians must be aware of how availability of these new medications may impact patients' adherence to their treatment regimens and begin taking steps now to address these potential issues. © 2014 Informa UK Ltd.

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