bluuebunny/crossref_metadata_2025 huggingface dataset:
Epidemiology of Cardiovascular Disease in Type 2 Diabetes: The Indian Scenario
Authors: Mohan Viswanathan , Venkatraman Janarthanan Vijay , Pradeepa Rajendra
Published: January 2014

Noncommunicable diseases, of which coronary artery disease (CAD) and diabetes top the list, have overtaken communicable diseases with respect to overall mortality, even in developing countries like India. High prevalence rates of diabetes and CAD are seen not only in affluent migrant Indians, but also in those living within the subcontinent. Indeed the epidemic of diabetes and CAD is now spreading to the middle- and lower-income groups in India. The risk for CAD is two to four times higher in diabetic subjects, and in Indians, CAD occurs prematurely, i.e., one to two decades earlier than in the West. Thus there is an urgent need for studies on CAD in diabetic and nondiabetic subjects in India.

The Chennai Urban Population Study, a population-based study in Chennai, in South India, showed a prevalence of CAD of 11%, which is 10 times more than what it was in 1970. Clustering of risk factors for CAD such as hyperglycemia, central body obesity, dyslipidemia, and hypertension tends to occur, and interplay of these risk factors could explain the enhanced CAD risk in Indians. Additionally, low-grade inflammation and a possible inherent genetic susceptibility are other contributing factors. Preventive measures such as lifestyle modification with healthy diet, adequate physical activity, and decrease in stress could help prevent the twin epidemics of diabetes and CAD.
Amperometric Glucose Sensors: Sources of Error and Potential Benefit of Redundancy
Authors: Castle Jessica R. , Ward W. Kenneth
Published: January 2014

Amperometric glucose sensors have advanced the care of patients with diabetes and are being studied to control insulin delivery in the research setting. However, at times, currently available sensors demonstrate suboptimal accuracy, which can result from calibration error, sensor drift, or lag. Inaccuracy can be particularly problematic in a closed-loop glycemic control system. In such a system, the use of two sensors allows selection of the more accurate sensor as the input to the controller. In our studies in subjects with type 1 diabetes, the accuracy of the better of two sensors significantly exceeded the accuracy of a single, randomly selected sensor. If an array with three or more sensors were available, it would likely allow even better accuracy with the use of voting.
Do Incretin-Based Therapies Cause Acute Pancreatitis?
Authors: Olansky Leann
Published: January 2014

In 2007 a question was raised about the causal relationship between the first of the glucagon-like peptide 1 receptor agonists, exenatide, and pancreatitis, as postmarketing reports of pancreatitis in patients treated with this agent had been received by the Food and Drug Administration (FDA). There had been six reports of hemorrhagic pancreatitis, with two of the cases resulting in death. An update of the package insert for Byetta was mandated. Sitagliptin entered the market about a year and a half later, and now there are similar reports of acute pancreatitis. As the number of patients treated with these agents increases, is it uncovering a risk not appreciated in the premarket phase or just what should be expected from the population treated with these agents? To date, 88 cases of acute pancreatitis have been reported to the FDA in patients taking sitagliptin (Januvia/Janumet). Of these, two cases have been hemorrhagic or necrotizing pancreatitis. A revision of the package insert for sitagliptin has been made recently. An examination of available data should help shed light on whether the relation is likely causal or merely incidental.
Evolution of Diabetes Insulin Delivery Devices
Authors: Selam Jean-Louis
Published: January 2014

The first manufactured insulin pump was introduced in the 1970s and the first insulin pens in 1985; since then, many improvements have been made to both devices. The advantages of pens over syringes have been confirmed in numerous studies and include greater accuracy, ease of use, patient satisfaction, quality of life, and adherence. United States claims database analyses indicate that the improved adherence made possible by use of an insulin pen has the potential to reduce diabetes care costs when compared with using a vial and syringe. Features of certain advanced pump models include the ability to connect wirelessly to a blood glucose meter or to a subcutaneous interstitial glucose sensor for semicontinuous glucose-driven insulin rate adjustment. A new trend in the design of insulin pumps is the tubing-free patch pump that adheres directly to the skin. The low rate of insulin pen usage in the United States compared with European countries and the fact that many patients report that they are not offered the option of an insulin pen by their physician suggest that there is a need to increase patient and provider awareness of the currently available devices for insulin administration.
Predictors of Initiating Rapid-Acting Insulin Analog Using Vial/Syringe, Prefilled Pen, and Reusable Pen Devices in Patients with Type 2 Diabetes
Authors: Lee Lauren J. , Anderson Julie , Foster Shonda A. , Corrigan Sheila M. , Smith David M. , Curkendall Suellen
Published: January 2014

Background:

Limited data are available on the predictors of insulin delivery device choice. This study assessed the patient- and health-care-system-related factors that predict the initiation of one rapid-acting insulin analog (RAIA) delivery system over another.

Methods:

A retrospective analysis using a claims database (January 1, 2007, through March 31, 2009) was conducted. Patients were required to be diagnosed with type 2 diabetes mellitus, and have ≥12 months of continuous eligibility prior to their first prescription of a RAIA on or after January 1, 2008. The three cohorts in the study were vial/syringe ( n = 6820), prefilled pen ( n = 5840), and reusable pen ( n = 2052). Multiple factors were examined using stepwise logistic regression.

Results:

Factors that increased the likelihood of initiating RAIA using prefilled pen versus vial/syringe included endocrinologist visit [odds ratio (OR) = 3.13, 95% confidence interval (CI) = 2.56, 3.82], prior basal insulin use with pen (OR = 4.85, 95% CI = 4.21, 5.59), and use of ≥1 oral antihyperglycemic agents (OR = 1.32, 95% CI = 1.20, 1.45). Factors that decreased the likelihood included inpatient admission (OR = 0.76, 95% CI = 0.70, 0.83), nursing home visit (OR = 0.22, 95% CI = 0.18, 0.27), and obesity (OR = 0.67, 95% CI = 0.53, 0.83). There were fewer differences between prefilled and reusable pen initiators. Factors that increased the likelihood of initiating with prefilled versus reusable pen included endocrinologist visit (OR = 1.87, CI = 1.50, 2.34) and inpatient admission (OR = 1.46, 95% CI = 1.30, 1.64).

Conclusion:

Significant differences in predictors were observed between prefilled pen and vial/syringe initiators. The differences were fewer between prefilled and reusable pen initiators. These differences should be taken into consideration when evaluating outcomes associated with specific insulin delivery systems.
Impact of Blood Glucose Self-Monitoring Errors on Glucose Variability, Risk for Hypoglycemia, and Average Glucose Control in Type 1 Diabetes: An In Silico Study
Authors: Breton Marc D. , Kovatchev Boris P.
Published: January 2014

Background:

Clinical trials assessing the impact of errors in self-monitoring of blood glucose (SMBG) on the quality of glycemic control in diabetes are inherently difficult to execute. Consequently, the objectives of this study were to employ realistic computer simulation based on a validated model of the human metabolic system and to provide potentially valuable information about the relationships among SMBG errors, risk for hypoglycemia, glucose variability, and long-term glycemic control.

Methods:

Sixteen thousand computer simulation trials were conducted using 100 simulated adults with type 1 diabetes. Each simulated subject was used in four simulation experiments aiming to assess the impact of SMBG errors on detection of hypoglycemia (experiment 1), risk for hypoglycemia (experiment 2), glucose variability (experiment 3), and long-term average glucose control, i.e., estimated hemoglobin A1c (HbA1c)(experiment 4). Each experiment was repeated 10 times at each of four increasing levels of SMBG errors: 5, 10, 15, and 20% deviation from the true blood glucose value.

Results:

When the permitted SMBG error increased from 0 to 5–10% to 15–20%—the current level allowed by International Organization for Standardization 15197—(1) the probability for missing blood glucose readings of 60 mg/dl increased from 0 to 0–1% to 3.5–10%; (2) the incidence of hypoglycemia, defined as reference blood glucose ≤70 mg/dl, changed from 0 to 0–0% to 0.1–5.5%; (3) glucose variability increased as well, as indicated by control variability grid analysis; and (4) the incidence of hypoglycemia increased from 15.0 to 15.2–18.8% to 22–25.6%. When compensating for this increase, glycemic control deteriorated with HbA1c increasing gradually from 7.00 to 7.01–7.12% to 7.26–7.40%.

Conclusions:

A number of parameters of glycemic control deteriorated substantially with the increase of permitted SMBG errors, as revealed by a series of computer simulations (e.g., in silico) experiments. A threshold effect apparent between 10 and 15% permitted SMBG error for most parameters, except for HbA1c, which appeared to be increasing relatively linearly with increasing SMBG error above 10%.
Frequently Repeated Glucose Measurements Overestimate the Incidence of Inpatient Hypoglycemia and Severe Hyperglycemia
Authors: Weinberg Melissa E. , Bacchetti Peter , Rushakoff Robert J.
Published: January 2014

Objective:

The aim was to determine if frequently repeated glucose measurements mandated by an inpatient protocol led to falsely elevated reported rates of both hypo- and hyperglycemia.

Methods:

In our academic medical center, a mandatory standardized subcutaneous insulin order form and protocol was implemented in May 2006. We analyzed point-of-care blood glucose (BG) measurements collected on all medical/surgical wards during the month of August in both 2005 and 2006 by all BGs measured, by patient admission, and by monitored patient-day. We then repeated all analyses using an algorithm that excluded BG values if another BG was measured less than 5 minutes later or 5–60 minutes earlier.

Results:

In 2005 versus 2006, there were 7034 versus 8016 glucoses measured in 397 versus 389 patients over 1704 versus 1710 patient days, respectively. Analyses based on patient-day balanced differences in BG measurement frequency and patient length of stay. In both years, failure to exclude repeat values overestimated both the proportion of patient days with hypoglycemia (3.5% versus 1.8% in 2005, p = .003; 2.6% versus 1.3% in 2006, p = .007) and severe hyperglycemia (9.3% versus 7.4% in 2005, p = .09; 7.7% versus 5.9% in 2006, p = .08). Mean, median, and proportion of patient-day means within our target range (80–150 mg/dl) were not significantly different.

Conclusions:

Glucometric reports should exclude repeated BG measurements from a single clinical episode of hypo- or hyperglycemia in order to accurately reflect inpatient glycemic control.
Assessment of the Mixing Efficiency of Neutral Protamine Hagedorn Cartridges
Authors: Kaiser Pia , Maxeiner Sebastian , Weise Alexander , Nolden Florain , Borck Anja , Forst Thomas , Pfützner Andreas
Published: January 2014

Reliable application of neutral protamine Hagedorn (NPH) insulin requires previous resuspension of the suspension by tipping over the cartridge 20 times. This procedure is considered annoying by patients. The goal of this investigation was to assess the efficiency of the mixing procedure when performed less frequently than recommended. Neutral protamine Hagedorn insulin cartridges from five different manufacturers (sanofi-aventis, Lilly, Berlin-Chemie, B. Braun, and Novo Nordisk) were emptied with doses of 28 IU in the morning and the evening over 5 days. While the first dose was obtained after a regular resuspension procedure (20× tipping over), the consecutive doses were obtained after 3, 6, 10, or 20 mixing procedures (12 cartridges per experimental series, two doses/day). Insulin concentrations of doses 1, 2, 6, and 10 were determined by high-pressure liquid chromatography. Between dosing, cartridges were stored at room temperature in a horizontal position. Comparable insulin concentrations were seen in the first correctly prepared doses. Pronounced and substantial deviations from the selected dose were observed with most of the cartridges, in particular when resuspending only 3 and 6 times. Mean absolute percentage deviations when tipping 3 times and maximally observed overdoses were: Insuman basal: 1.1 ± 1.0%/4 IU, Humulin N: 2.6 ± 3.4%/19 IU, Berlinsulin H basal: 4.4 ± 6.0%/26 IU, Insulin B. Braun basal: 10.4 ± 8.9%/38 IU, and Protaphane: 4.7 ± 4.1%/19 IU (all p < 0.05 vs Insuman basal). Only one cartridge with three metal mixing bullets (sanofi-aventis) was resuspended efficiently with only a few mixing procedures. All other cartridges with fewer bullets were shown to deliver potentially harmful doses if used for treatment when the mixing procedure was less frequent than demanded in the instructions for use.
Strategies to Increase Adherence through Diabetes Technology
Authors: Gabbay Robert A. , Durdock Kendra
Published: January 2014

A variety of new technologies have been developed to assist patients with self-managing their diabetes and yet hemoglobin A1c has not changed dramatically over the last decade. Although more data available from these new diabetes technologies can be helpful, it is clear that an informed, motivated, and adherent patient is the key to success. This article focuses on increasing patient adherence through the use of motivational interviewing, an evidence-based behavior change counseling technique. Specific skills of motivational interviewing may help the provider assess what the patient already knows about the technology, explore the patient's motivation for using the technology, and, finally, assess the patient's barriers, importance, and confidence in using the technology, leading to better adherence.
Laboratory Evaluation of a New Lateral-Flow-Based Point-of-Care Rapid Test for Assessment of Chronic Systemic Inflammation
Authors: Siebenhaar Renate , Mushholt Petra B. , Forst Thomas , Weber Matthias M. , Maurer Robert , Pfützner Andreas
Published: January 2014

The determination of C-reactive protein (CRP) by means of a highly sensitive laboratory method as an independent biomarker for assessment of chronic systemic vascular inflammation and cardiovascular risk is recommended by therapeutic guidelines for diabetes and cardiovascular disease in the United States and in Europe. The purpose of this investigation was to investigate the specificity and sensitivity of a newly developed lateral-flow-based point-of-care (POC) rapid test with semi-quantitative visual reading in comparison with a laboratory reference standard method.

The high-sensitivity CRP concentrations of 66 samples were determined by means of turbidimetry and the POC test (5 μl serum/10 μl capillary whole blood, 10 minutes) was independently performed by three investigators blinded to each other's results. The visual readings were classified, as recommended by the American Heart Association, to represent a low risk (0–1 mg/liter), moderate risk (>1–3 mg/liter), or high risk (>3–10 mg/liter) or to indicate an unspecific inflammation (>10 mg/liter).

According to the reference method, there were 17 samples in the low-risk group, 19 samples in the moderate-risk group, and 26 samples in the high-risk group, and 4 samples showed an unspecific inflammation. All three investigators reached very conclusive results. The range of agreement between the visual readings of the investigators and the laboratory method ranged between 94% and 97%. The sensitivity for assessment of moderate-to-high cardiovascular risk was 100% (45/45 were detected), and the specificity ranged between 90% and 95%.

The newly developed lateral-flow-based POC rapid test showed an excellent agreement between individual visual reading and the laboratory reference method. It may therefore be suitable for a fast and convenient screening, which, after laboratory test confirmation, may help to identify patients with elevated risk of macrovascular disease.
Insulin Absorption from Lipodystrophic Areas: A (Neglected) Source of Trouble for Insulin Therapy?
Authors: Heinemann Lutz
Published: January 2014

The experienced clinical diabetologist first checks the skin at the area where the patient usually injects his insulin when he sees widely fluctuating blood glucose levels in the diary of the patient. He knows that insulin absorption from skin with lipodystrophic changes is irregular. However, our scientific knowledge about why this is the case is very limited. Most probably, the number of blood vessels near the insulin depot in the subcutaneous tissue varies depending on the nature of the lipodystrophic changes, or the structural changes in this tissue hamper the diffusion of insulin. Not only is our knowledge about the number of patients who exhibit such changes very limited, but also our understanding why such changes show up in certain patients and not in others is minimal. More practically important, we also have few quantitative studies investigating the impact of this diabetes-related complication on insulin absorption/insulin action; however, it is not difficult to run such studies in practice. Nevertheless, it is impressive to see how often metabolic control improves considerably once the patients apply the insulin into other skin areas.
Consumer Engagement for Diabetes Technology: Easier Said Than Done
Authors: Gruber David
Published: January 2014

Direct spending on diabetes, already exceeding $118 billion, is forecast to reach $336 billion in 2034, driven by newly diagnosed cases secondary to an aging, increasingly sedentary, obese population and the advent of comorbidities, particularly cardiovascular complications affecting more than one-third of persons with diabetes. Traditional, directive, and fragmented approaches to patient management based on acute intervention and specialty care has been unable to stem the impending tsunami of diabetes-related complications and costs. Health care reform and the growing shortage of primary care physicians will only exacerbate the situation.

Consumer-centric health care, enabled by digital media and technology, is integral to engagement, self-management, behavior change, and outcomes. It is time for the health care establishment to consider the “other” 360 days per year when a patient is not being seen by a physician.
Assessing Postural Control and Postural Control Strategy in Diabetes Patients Using Innovative and Wearable Technology
Authors: Najafi Bijan , Horn Deena , Marclay Samuel , Crews Ryan T. , Wu Stephanie , Wrobel James S.
Published: January 2014

Introduction:

Currently, diagnosis of patients with postural instability relies on a rudimentary clinical examination. This article suggests an innovative, portable, and cost-effective prototype to evaluate balance control objectively.

Methods:

The proposed system uses low-cost, microelectromechanical sensor, body-worn sensors (BalanSens™) to measure the motion of ankle and hip joints in three dimensions. We also integrated resulting data into a two-link biomechanical model of the human body for estimating the two-dimensional sway of the center of mass (COM) in anterior-posterior (AP) and medial-lateral (ML) directions. A new reciprocal compensatory index (RCI) was defined to quantify postural compensatory strategy (PCS) performance. To validate the accuracy of our algorithms in assessing balance, we investigated the two-dimensional sway of COM and RCI in 21 healthy subjects and 17 patients with diabetic peripheral neuropathic (DPN) complications using the system just explained. Two different conditions were examined: eyes open (EO) and eyes closed (EC) for duration of at least 30 seconds. Results were compared with center of pressure sway (COP) as measured by a pressure platform (Emed-x system, Novel Inc., Germany). To further investigate the contribution of the somatosensory (SOM) feedback to balance control, healthy subjects performed EO and EC trials while standing on both a rigid and a foam surface.

Results:

A relatively high correlation was observed between COM measured using BalanSens and COP measured using the pressure platform ( r = 0.92). Results demonstrated that DPN patients exhibit significantly greater COM sway than healthy subjects for both EO and EC conditions ( p < 0.005). The difference becomes highly pronounced while eyes are closed (197 ± 44 cm2 vs 68 ± 56 cm2). Furthermore, results showed that PCS assessed using RCI is significantly better in healthy subjects compared to DPN subjects for both EO and EC conditions, as well as in both ML and AP directions ( p < 0.05). Alteration in SOM feedback in healthy subjects resulted in diminished RCI values that were similar to those seen in DPN subjects ( p > 0.05).

Discussion/Conclusion:

This study suggested an innovative system that enables the investigation of COM as well as postural control compensatory strategy in humans. Results suggest that neuropathy significantly impacts PCS.
Association between Foot Temperature and Sudomotor Dysfunction in Type 2 Diabetes
Authors: Papanas Nikolaos , Papatheodorou Konstantinos , Papazoglou Dimitrios , Kotsiou Stamatia , Maltezos Efstratios
Published: January 2014

Background and Aims:

Increased foot skin temperature has been described as a feature of diabetic neuropathy. The aim of this present study was to investigate the association between foot temperature and sudomotor dysfunction in type 2 diabetes mellitus.

Patients and Methods:

This study included 51 patients (group A: 25 men, mean age 61.14 ± 6.11 years) without sudomotor dysfunction and 52 patients (group B: 25 men, mean age 59.54 ± 6.18 years) with sudomotor dysfunction. Sudomotor dysfunction was defined as time until complete Neuropad™ color change from blue to pink exceeding 600 s in at least one foot. Time until complete color change of the test was also recorded. Foot skin temperature was measured with a handheld infrared thermometer on the plantar aspect of the foot at the level of the first metatarsal head.

Results:

On both feet, temperature was significantly higher in group B than in group A (right foot, group A versus group B, 30.62 ± 1.13 °C versus 32.12 ± 1.06 °C, p < .001; left foot, group A versus group B, 30.65 ± 1.06 °C versus 32.19 ± 1.10 °C, p < .001). There was a significant positive correlation between time to complete Neuropad color change and foot skin temperature (right foot, r = 0.742, p < .001; left foot, r = 0.758, p < .001), which was confirmed in both groups.

Conclusions:

Patients with sudomotor dysfunction have significantly higher foot temperature than those without sudomotor dysfunction. Foot temperature is positively correlated with severity of sudomotor dysfunction, as evaluated by the time to complete Neuropad color change.
The Micrograft Concept for Wound Healing: Strategies and Applications
Authors: Biswas Atanu , Bharara Manish , Hurst Craig , Armstrong David G. , Rilo Horacio
Published: January 2014

The standard of care for wound coverage is to use an autologous skin graft. However, large or chronic wounds become an exceptionally challenging problem especially when donor sites are limited. It is important that the clinician be aware of various treatment modalities for wound care and incorporate those methods appropriately in the proper clinical context. This report reviews an alternative to traditional meshed skin grafting for wound coverage: micrografting. The physiological concept of micrografting, along with historical context, and the evolution of the technique are discussed, as well as studies needed for micrograft characterization and future applications of the technique.
The SNaP™ Wound Care System: A Case Series Using a Novel Ultraportable Negative Pressure Wound Therapy Device for the Treatment of Diabetic Lower Extremity Wounds
Authors: Lerman Bruce , Oldenbrook Leslie , Ryu Justin , Fong Kenton D. , Schubart Peter J.
Published: January 2014

Although there is significant evidence supporting the use of negative pressure wound therapy (NPWT) for the treatment of lower extremity diabetic ulcers, currently available electrically powered NPWT systems are not ideally suited for treating smaller diabetic foot ulcers. The Smart Negative Pressure (SNaP™) Wound Care System is a novel, ultraportable device that delivers NPWT without the use of an electrically powered pump. It was specifically designed to meet the wound care needs of patients with diabetes. The SNaP System is compact, silent, mobile, easy-to-use, and available off-the-shelf. It is fully disposable and may offer other important benefits over electrically powered systems to both the clinician and patient. We review the evidence for use of NPWT for the treatment of diabetic wounds and discuss the potential benefits of this new NPWT technology for patients with diabetes. We also present a case series of four difficult lower extremity diabetic ulcers that were successfully treated with the SNaP System. This study suggests that the SNaP System may be a useful addition to the armamentarium of the diabetic wound care clinician.
Analysis of the SNaP™ Wound Care System, a Negative Pressure Wound Device for Treatment of Diabetic Lower Extremity Wounds
Authors: Landsman Adam
Published: January 2014

Negative pressure wound therapy (NPWT) has become a widely used modality for the treatment of complex wounds. However, patient compliance is frequently difficult due to the need to carry a bulky, noisy electronic device. In this issue of Journal of Diabetes Science and Technology, Lerman and colleagues describe a new system that uses no electricity and is about the size of a deck of cards. It is designed to be stored in the clinic and applied almost as simply as a standard wound dressing. Four cases are reviewed to demonstrate that the device is efficacious and helps to encourage patient compliance. No statistically significant outcomes are presented. By removing compliance barriers, this device may encourage more frequent NPWT applications for small wounds.
Diabetic Foot Biomechanics and Gait Dysfunction
Authors: Wrobel James S. , Najafi Bijan
Published: January 2014

Background:

Diabetic foot complications represent significant morbidity and precede most of the lower extremity amputations performed. Peripheral neuropathy is a frequent complication of diabetes shown to affect gait. Glycosylation of soft tissues can also affect gait. The purpose of this review article is to highlight the changes in gait for persons with diabetes and highlight the effects of glycosylation on soft tissues at the foot-ground interface.

Methods:

PubMed, the Cochrane Library, and EBSCOhost® on-line databases were searched for articles pertaining to diabetes and gait. Bibliographies from relevant manuscripts were also searched.

Findings:

Patients with diabetes frequently exhibit a conservative gait strategy where there is slower walking speed, wider base of gait, and prolonged double support time. Glycosylation affects are observed in the lower extremities. Initially, skin thickness decreases and skin hardness increases; tendons thicken; muscles atrophy and exhibit activation delays; bones become less dense; joints have limited mobility; and fat pads are less thick, demonstrate fibrotic atrophy, migrate distally, and may be stiffer.

Interpretation:

In conclusion, there do appear to be gait changes in patients with diabetes. These changes, coupled with local soft tissue changes from advanced glycosylated end products, also alter a patient's gait, putting them at risk of foot ulceration. Better elucidation of these changes throughout the entire spectrum of diabetes disease can help design better treatments and potentially reduce the unnecessarily high prevalence of foot ulcers and amputation.
Outpatient-to-Inpatient Transition of Insulin Pump Therapy: Successes and Continuing Challenges
Authors: Nassar Adrienne A. , Partlow Brenda J. , Boyle Mary E. , Castro Janna C. , Bourgeois Peggy B. , Cook Curtiss B.
Published: January 2014

Background:

Insulin pump therapy is a complex technology prone to errors when employed in the hospital setting. When patients on insulin pump therapy require hospitalization, practitioners caring for them must decide whether to allow continued pump use. We provide the largest review regarding transitioning insulin pump therapy from the outpatient to inpatient setting.

Method:

Records of inpatient insulin pump users were retrospectively analyzed at a metropolitan Phoenix hospital between January 2006 and December 2009. Adherence to institutional procedures on insulin pump use was assessed, glycemic control was determined, and adverse events were examined.

Results:

We examined records on 65 patients with insulin pumps, totaling 125 hospitalizations. Mean (standard deviation) patient age was 55 (17) years, diabetes duration was 27 (14) years, pump duration was 6 (5) years, length of hospital stay was 4.7 (6.3) days, hemoglobin A1c was 7.3 (1.3)%, 85% had type 1 diabetes mellitus, 57% were women, and 97% were white. Admissions involving insulin pumps increased (23 in 2006, 17 in 2007, 40 in 2008, and 45 in 2009). Insulin pump therapy was continued in 83 (66%) hospitalizations. Among these hospitalizations, endocrinology consultations were obtained in 89%, consent agreements were found in 83%, insulin pump order sets were completed in 89%, admission glucose was checked in 100%, and nursing assessments of pump insertion sites were documented in 89%, but bedside insulin pump flow sheets were found in only 55%. Mean glucose of 175 (57) mg/dl was not significantly different than that in hospitalizations where insulin pumps were discontinued [175 (42) mg/dl] or used intermittently [177 (7) mg/dl]. There was one instance of a pump catheter kinking; however, no other adverse events (pump site infections, mechanical pump failure, diabetic ketoacidosis) were observed, and there were no use-related fatalities.

Conclusions:

Most patients using insulin pumps can safely have their therapy transitioned when hospitalized. A policy on inpatient continuous subcutaneous insulin infusion use can be successfully implemented. Compliance with required procedures can be achieved, although there was room to improve adherence with some process measures. Further study is needed to determine how to optimize glycemic control when pumps are allowed during hospitalization.
Nonlinear Metabolic Effect of Insulin Across the Blood Glucose Range in Patients with Type 1 Diabetes Mellitus
Authors: Chan Alice , Heinemann Lutz , Anderson Stacey M. , Breton Marc D. , Kovatchev Boris P.
Published: January 2014

Background:

For insulin therapy to successfully maintain blood glucose (BG) levels of patients with type 1 diabetes mellitus (T1DM) in normoglycemia, it is necessary to understand if the metabolic effect of insulin across the BG range is linear or not.

Methods:

We assess the ability of insulin to lower BG in patients with T1DM in hypoglycemia and hyperglycemia. The net metabolic effect of insulin, defined as the total effect resulting from both reduced endogenous glucose production and increased glucose uptake, was used to define the insulin effectiveness (IE), a measure that indicates the amplitude of glucose lowering that a unit of active insulin can achieve at a given BG level. The IE was assessed in hypoglycemia and hyperglycemia through two separate studies. In the first study, patients were subjected to a hyperinsulinemic euglycemic and hypoglycemic glucose clamp. In the second study, another group of patients were clamped at a hyperglycemic level.

Results:

The IE increased by 75% when BG dropped from 90 to 50 mg/dl at a steady rate of 1 mg/d1/min and decreased by 10% when BG was increased from 100 to 200 mg/d1.

Conclusions:

The net metabolic effect of insulin is nonlinear across the BG range and is amplified in hypoglycemia and dampened in hyperglycemia. Most importantly, the BG lowering per unit of insulin is accelerated when falling into hypoglycemia. The understanding of the accelerated risk for hypoglycemia with falling glucose levels will help the design of more robust hypoglycemia prevention and detection systems.
Bolus Guide: A Novel Insulin Bolus Dosing Decision Support Tool Based on Selection of Carbohydrate Ranges
Authors: Shapira Gali , Yodfat Ofer , HaCohen Arava , Feigin Paul , Rubin Richard
Published: January 2014

Background:

Optimal continuous subcutaneous insulin infusion (CSII) therapy emphasizes the relationship between insulin dose and carbohydrate consumption. One widely used tool (bolus calculator) requires the user to enter discrete carbohydrate values; however, many patients might not estimate carbohydrates accurately. This study assessed carbohydrate estimation accuracy in type 1 diabetes CSII users and compared simulated blood glucose (BG) outcomes using the bolus calculator and the “bolus guide,” an alternative system based on ranges of carbohydrate load.

Methods:

Patients ( n = 60) estimated the carbohydrate load of a representative sample of meals of known carbohydrate value. The estimated error distribution [coefficient of variation (CV)] was the basis for a computer simulation ( n = 1.6 million observations) of insulin recommendations for the bolus guide and bolus calculator, translated into outcome blood glucose (OBG) ranges (=60, 61–200, >201 mg/dl). Patients ( n = 30) completed questionnaires assessing satisfaction with the bolus guide.

Results:

The CV of typical meals ranged from 27.9% to 44.5%. The percentage of simulated OBG for the calculator and the bolus guide in the <60 mg/dl range were 20.8% and 17.2%, respectively, and 13.8% and 15.8%, respectively, in the >200 mg/dl range. The mean and median scores of all bolus guide satisfaction items and ease of learning and use were 4.17 and 4.2, respectively (of 5.0).

Conclusion:

The bolus guide recommendation based on carbohydrate range selection is substantially similar to the calculator based on carbohydrate point estimation and appears to be highly accepted by type 1 diabetes insulin pump users.
A Review of the “Bolus Guide,” a New Insulin Bolus Dosing Support Tool Based on Selection of Carbohydrate Ranges
Authors: Pańkowska Ewa
Published: January 2014

In this issue of Journal of Diabetes Science and Technology, Shapira and colleagues present new concepts of carbohydrate load estimation in intensive insulin therapy. By using a mathematical model, they attempt to establish how accurately carbohydrate food content should be maintained in order to keep postprandial blood glucose levels in the recommended range. Their mathematical formula, the “bolus guide” (BG), is verified by simulating prandial insulin dosing and responding to proper blood glucose levels. Different variants such as insulin sensitivity factor, insulin-to-carbohydrate ratio, and target blood glucose were taken into this formula in establishing the calculated proper insulin dose. The new approach presented here estimates the carbohydrate content by rearranging the carbohydrate load instead of the simple point estimation that the current bolus calculators (BCs) use. Computerized estimations show that the BG directives, as compared to a BC, result in more glucose levels above 200 mg/dl and thus indicate less hypoglycemia readings.
A Single-Center, Open, Comparative Study of the Effect of Using Self-Monitoring of Blood Glucose to Guide Therapy on Preclinical Atherosclerotic Markers in Type 2 Diabetic Subjects
Authors: Mohan Viswanathan , Ravikumar Radhakrishnan , Poongothai Subramani , Amutha Anandakumar , Sowmya Santhamma , Karkhuzali Kulasegaran , Parkin Christopher G.
Published: January 2014

Background:

The aim of our study was to determine the effect of treatment based on preprandial and postprandial self-monitoring of blood glucose (SMBG) on the progression of carotid intima-medial thickness (CIMT) in noninsulin-treated type 2 diabetes mellitus (T2DM) subjects.

Methods:

In this 18-month prospective trial, we recruited subjects 18–70 years of age, treated with metformin and sulfonylurea, with a standardized hemoglobin A1c (HbA1c) level ⩽9.0%. Subjects were randomized to use of fasting/preprandial (FP) SMBG results to adjust evening medication or use of postprandial (PP) SMBG results to adjust morning medication. The primary end point was change in CIMT; change in HbA1c was a secondary end point.

Results:

Of the 300 subjects randomized, 280 (140 in each group) completed all biochemical tests and CIMT analysis. Carotid intima-medial thickness was reduced significantly in PP subjects from 0.78 (±0.15) mm to 0.73 (±0.14) mm ( p < 0.005), but no significant CIMT reduction was seen in FP subjects. A significant reduction in HbA1c was also seen in the PP group ( p < 0.005) but not in the FP group 1 ( p = 0.165). significant improvements in body mass index ( p = 0.038), waist circumference ( p < 0.001), systolic blood pressure ( p = 0.008), and serum cholesterol ( p = 0.02) were also seen in PP subjects but not in FP subjects.

Conclusion:

Use of postprandial SMBG data to adjust therapy was associated with a significant regression of carotid intima-medial thickening and a reduction in HbA1c in T2DM, whereas no significant improvement in these parameters was seen in subjects who used fasting/preprandial SMBG data for therapy adjustment.
Evolution of Data Management Tools for Managing Self-Monitoring of Blood Glucose Results: A Survey of iPhone Applications
Authors: Rao Anoop , Hou Philip , Golnik Timothy , Flaherty Joseph , Vu Sonny
Published: January 2014

Background:

Studies have indicated that sharing of self-monitoring of blood glucose (SMBG) data and subsequent feedback from the health care provider (HCP) can help achieve glycemic goals such as a reduction in glycated hemoglobin. Electronic SMBG data management and sharing tools for the PC and smartphones may help in reducing the effort to manage SMBG data.

Methods:

We reviewed software and top-ranking applications (Apps) for the iPhone platform to document the variety of useful features. Additionally, in an attempt to assess metrics such as task analysis and user friendliness of diabetes Apps, we observed and surveyed patients with diabetes as they recorded and relayed sample SMBG results to their hypothetical HCP using three Apps.

Results:

Observation and survey demonstrated that the WaveSense Diabetes Manager allowed the participants to complete preselected SMBG data entry and relay tasks faster than other Apps. The survey revealed patient behavior patterns that would be useful in future App development.

Conclusion:

Being able to record, analyze, seamlessly share, and obtain feedback on the SMBG data using an iPhone/iTouch App might potentially benefit patients. Trends in SMBG data management and the possibility of having interoperability of blood glucose monitors and smartphones may open up new avenues of diabetes management for the technologically savvy patient.
Zone Model Predictive Control: A Strategy to Minimize Hyper- and Hypoglycemic Events
Authors: Grosman Benyamin , Dassau Eyal , Zisser Howard C. , Jovanovič Lois , Doyle Francis J.
Published: January 2014

Background:

Development of an artificial pancreas based on an automatic closed-loop algorithm that uses a subcutaneous insulin pump and continuous glucose sensor is a goal for biomedical engineering research. However, closing the loop for the artificial pancreas still presents many challenges, including model identification and design of a control algorithm that will keep the type 1 diabetes mellitus subject in normoglycemia for the longest duration and under maximal safety considerations.

Method:

An artificial pancreatic β-cell based on zone model predictive control (zone-MPC) that is tuned automatically has been evaluated on the University of Virginia/University of Padova Food and Drug Administration-accepted metabolic simulator. Zone-MPC is applied when a fixed set point is not defined and the control variable objective can be expressed as a zone. Because euglycemia is usually defined as a range, zone-MPC is a natural control strategy for the artificial pancreatic β-cell. Clinical data usually include discrete information about insulin delivery and meals, which can be used to generate personalized models. It is argued that mapping clinical insulin administration and meal history through two different second-order transfer functions improves the identification accuracy of these models. Moreover, using mapped insulin as an additional state in zone-MPC enriches information about past control moves, thereby reducing the probability of overdosing. In this study, zone-MPC is tested in three different modes using unannounced and announced meals at their nominal value and with 40% uncertainty. Ten adult in silico subjects were evaluated following a scenario of mixed meals with 75, 75, and 50 grams of carbohydrates (CHOs) consumed at 7 am, 1 pm, and 8 pm, respectively. Zone-MPC results are compared to those of the “optimal” open-loop preadjusted treatment.

Results:

Zone-MPC succeeds in maintaining glycemic responses closer to euglycemia compared to the “optimal” open-loop treatment in te three different modes with and without meal announcement. In the face of meal uncertainty, announced zone-MPC presented only marginally improved results over unannounced zone-MPC. When considering user error in CHO estimation and the need to interact with the system, unannounced zone-MPC is an appealing alternative.

Conclusions:

Zone-MPC reduces the variability of control moves over fixed set point control without the need to detune the controller. This strategy gives zone-MPC the ability to act quickly when needed and reduce unnecessary control moves in the euglycemic range.
Pilot Study for Assessment of Optimal Frequency for Changing Catheters in Insulin Pump Therapy—Trouble Starts on Day 3
Authors: Schmid Volkmar , Hohberg Cloth , Borchert Marcus , Forst Thomas , Pfützner Andreas
Published: January 2014

Background:

Continuous subcutaneous insulin infusion (CSII) by means of insulin pump devices is considered to be one of the most optimal therapies to achieve treatment targets in patients with diabetes mellitus. In CSII, the insulin is delivered through Teflon catheters or steel needle infusion sets, which need to be renewed on a regular basis. This pilot study was performed to investigate the optimal change frequency in daily practice and to explore potential problems that may occur when the sets are used for a more prolonged time than the recommended up to 72 hours of usage (Teflon catheters).

Method:

Twelve patients with type 1 diabetes participated in the trial [age (mean ± STD): 40.3 ± 12.6 years, body mass index: 26.2 ± 3.3 kg/m2, hemoglobin A1c: 6.7 ± 0.6%]. They were asked to wear their infusion set (Comfort™ or Silhouette®) for increasing periods of 1, 2, 3, 4, and 5 days. After each use, patients completed standardized questionnaires regarding technical and medical issues associated with infusion set use. A health care professional investigated the infusion sites and infusion sets and completed an “infusion set inspection” questionnaire. Blood glucose was measured and recorded to assess a potential Influence of duration of catheter use on glycemic control.

Results:

Infusion set and injection site problems (itching, bruising, swelling, and pain) started to occur in measurable amounts on the 3rd day of catheter use, and about 40% of patients reported significant issues when using a catheter for 5 days. In parallel, there was a consistent increase in mean daily blood glucose levels that correlated with the number of days of catheter use (e.g., day 1: 7. 5 ± 3.8 mmol/liter, day 3: 8.4 ± 4.2 mmol/liter, day 5: 9.0 ± 4.0 mmol/liter, day 7: 11.6 ± 2.2 mmol/liter, p < 0.05 vs day 1).

Conclusions:

Using the catheters for 2 days resulted in a safe and well-tolerated therapy. Clinically relevant adverse events started to occur during the 3rd day and their incidence increased constantly with longer use. This was associated with undesired changes in mean glycemic control. Data support the recommendation by the drug and device manufacturers that insulin pump catheters should only be used for 48–72 hours to avoid adverse events and potential metabolic deterioration.
Fructose: Pure, White, and Deadly? Fructose, by Any other Name, is a Health Hazard
Authors: Bray George A.
Published: January 2014

The worldwide consumption of sucrose, and thus fructose, has risen logarithmically since 1800. Many concerns about the health hazards of calorie-sweetened beverages, including soft drinks and fruit drinks and the fructose they provide, have been voiced over the past 10 years. These concerns are related to higher energy intake, risk of obesity, risk of diabetes, risk of cardiovascular disease, risk of gout in men, and risk of metabolic syndrome. Fructose appears to be responsible for most of the metabolic risks, including high production of lipids, increased thermogenesis, and higher blood pressure associated with sugar or high fructose corn syrup. Some claim that sugar is natural, but natural does not assure safety.
Diabetes Telehealth and Computerized Decision Support Systems: A Sound System with a Human Touch is Needed
Authors: Holmström Inger
Published: January 2014

Telehealth holds the promise of improved consistency and fast and equal access to care, and will have great impact on future care. To enhance its quality and safety, computerized decision support systems (CDSS) have been launched. This commentary focuses specifically on the impact of telehealth and CDSS on diabetes patient management. Ideally, clinical information should be linked to evidence based recommendations and guidelines in the CDSS to provide tailored recommendations at the moment of care. However, technical support such as CDSS is not enough. The human touch is essential. A named healthcare provider with access to telehealth and CDSS seems to promise a way of providing both patient-centered and evidence-based care.