bluuebunny/crossref_metadata_2025 huggingface dataset:
The Indian Council of Medical Research—India Diabetes (ICMR-INDIAB) Study: Methodological Details
Authors: Anjana Ranjit Mohan , Pradeepa Rajendra , Deepa Mohan , Datta Manjula , Sudha Vasudevan , Unnikrishnan Ranjit , Nath Lalith M. , Das Ashok Kumar , Madhu Venkata , Rao Paturi Vishnupriya , Shukla Deepak Kumar , Kaur Tanvir , Ali Mohammed K. , Mohan Viswanathan
Published: January 2014

Background:

Currently available estimates of diabetes prevalence in India are based on published data derived from very few studies. The Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study is a community-based survey conceived with the aim of obtaining the prevalence rates of diabetes in India as a whole, covering all 28 states, the National Capital Territory of Delhi, and two of the union territories in the mainland of India, with a total sample size of 124,000 individuals.

Methods:

A stratified multistage sampling design has been used. In all study subjects, a structured questionnaire was administered and anthropometric parameters and blood pressure were measured. Fasting capillary blood glucose was first determined using a glucose meter. An oral glucose load was then administered to all subjects except those with self-reported diabetes, and the 2 h post-load capillary blood glucose was estimated. In every fifth subject, a fasting venous sample was collected for measurement of lipids and creatinine, a resting 12-lead electrocardiogram was performed, and dietary assessment questionnaire was administered. In all diabetic subjects, an additional diabetes questionnaire was used and a fasting venous sample drawn for glycated hemoglobin.

Results:

All biological samples collected were analyzed in a central laboratory. All data collected were stored electronically. Quality control was achieved through multiple tiers of checks.

Conclusions:

The ICMR-INDIAB study is the first of its kind attempting to provide accurate and comprehensive state- and national-level data on diabetes prevalence in India.
Remote Monitoring Technologies for the Prevention of Metabolic Syndrome: The Diabetes and Technology for Increased Activity (DaTA) Study
Authors: Stuckey Melanie , Fulkerson Robyn , Read Emily , Russell-Minda Elizabeth , Munoz Claudio , Kleinstiver Peter , Petrella Robert
Published: January 2014

Objectives:

Remote monitoring technologies are ideally suited for rural communities with limited access to health care. In an 8-week pilot study, we examined the feasibility of implementing and conducting a technology-intensive intervention in an underserviced rural setting. Our goal was to test the utility of self-monitoring technologies, physical activity, and education as tools to manage health indicators for the development of the cardiovascular complications (CVCs) of type 2 diabetes.

Research Design and Methods:

The Diabetes and Technology for Increased Activity study was an open single-center study conducted in a community-based research setting. All 24 participants were provided with a Blackberry™ Smartphone, blood pressure monitor, glucometer, and pedometer. Smartphones transmitted measurements and survey results to the database, interfaced participants with the clinical team, and allowed for self-monitoring.

Results:

Outcomes were improved body composition, improved markers of CVC risk factors, increased daily exercise, and interest in or awareness of lifestyle changes that impact health outcomes. Participants had excellent compliance for measurements, as self-monitoring provided a sense of security that improved from week 4 to week 8.

Conclusions:

Our team gained substantial insight into the operational requirements of technology-facilitated health care, including redefined hours of service; data reporting, management, and access protocols; and the utility of real-time clinical measures by remote monitoring. We developed an understanding of knowledge translation strategies as well as successful motivational and educational tools. Importantly, remote monitoring technology was found to be feasible and accepted in a rural setting.
Future Opportunities for Advancing Glucose Test Device Electronics
Authors: Young Brian R. , Young Teresa L. , Joyce Margaret K. , Kennedy Spencer I. , Atashbar Massood Z.
Published: January 2014

Advancements in the field of printed electronics can be applied to the field of diabetes testing. A brief history and some new developments in printed electronics components applicable to personal test devices, including circuitry, batteries, transmission devices, displays, and sensors, are presented. Low-cost, thin, and lightweight materials containing printed circuits with energy storage or harvest capability and reactive/display centers, made using new printing/imaging technologies, are ideal for incorporation into personal-use medical devices such as glucose test meters. Semicontinuous rotogravure printing, which utilizes flexible substrates and polymeric, metallic, and/or nano “ink” composite materials to effect rapidly produced, lower-cost printed electronics, is showing promise. Continuing research advancing substrate, “ink,” and continuous processing development presents the opportunity for research collaboration with medical device designers.
Usage and Effectiveness of the Low Glucose Suspend Feature of the Medtronic Paradigm Veo Insulin Pump
Authors: Agrawal Pratik , Welsh John B. , Kannard Brian , Askari Sina , Yang Qingqing , Kaufman Francine R.
Published: January 2014

Background:

Sensor-augmented insulin pumps may be programmed to suspend insulin delivery in response to hypoglycemia. The Medtronic Paradigm® Veo™ pump with automatic low glucose suspend (LGS) was released in 2009. Data from 7 months of real-world use of the system were analyzed to assess usage patterns and effectiveness of LGS.

Method:

Data from 935 patients totaling 49,867 patient days were collected; the LGS feature was on for 82% of these days. A subset of 278 subjects who used the pump for ≥3 months was analyzed separately; these subjects provided 28,401 patient days of data, with LGS used for 92% of the time.

Results:

The LGS threshold was most commonly set between 50 and 60 mg/dl. A total of 27,216 LGS events occurred, and 60% began in the afternoon or evening. The median duration of LGS events was 9.87 min, 45% lasted for <5 min, and 11% lasted for >115 min (equivalent to the full extent of the LGS event between 115 and 120 min). Among the episodes lasting for >115 min, the mean sensor glucose (SG) was 58.8 ± 12.4 mg/dl at LGS activation (time 0), rose to 102.2 ± 52.8 mg/dl by the end of the LGS episode (when insulin delivery was automatically resumed), and was 150.1 ± 68.6 mg/dl at 240 min. In the 278-subject subgroup, LGS usage significantly reduced the number of SG readings <50 mg/dl ( p = 0.001) and >300 mg/dl ( p = 0.001).

Conclusions:

The LGS feature was on for most of the patient days in the study. Most LGS episodes lasted for <10 min. Use of the LGS feature significantly reduced exposure to hypoglycemia. Profound hyperglycemia resulting from LGS episodes lasting >115 min was not observed.
Clinical Hurdles and Possible Solutions in the Implementation of Closed-Loop Control in Type 1 Diabetes Mellitus
Authors: Zisser Howard
Published: January 2014

From an engineering perspective, controlling blood glucose appears to be a fairly straightforward single input (glucose), single output (insulin) control problem. Unfortunately, mimicking Mother Nature turns out to be a complex endeavor. The primary hurdle in developing a useful, safe closed-loop control algorithm for an artificial pancreas is the time delays associated with current continuous glucose monitors and subcutaneously delivered insulins. This article will provide a brief history of the artificial pancreas, outline the main clinical hurdles restricting its current implementation, and list possible solutions for success.
Safe Glycemic Management during Closed-Loop Treatment of Type 1 Diabetes: The Role of Glucagon, Use of Multiple Sensors, and Compensation for Stress Hyperglycemia
Authors: Ward W. Kenneth , Castle Jessica R. , Youssef Joseph El
Published: January 2014

Patients with type 1 diabetes mellitus (T1DM) must make frequent decisions and lifestyle adjustments in order to manage their disorder. Automated treatment would reduce the need for these self-management decisions and reduce the risk for long-term complications. Investigators in the field of closed-loop glycemic control systems are now moving from inpatient to outpatient testing of such systems.

As outpatient systems are developed, the element of safety increases in importance. One such concern is the risk for hypoglycemia, due in part to the delayed onset and prolonged action duration of currently available subcutaneous insulin preparations. We found that, as compared to an insulin-only closed-loop system, a system that also delivers glucagon when needed led to substantially less hypoglycemia. Though the capability of glucagon delivery would mandate the need for a second hormone chamber, glucagon in small doses is tolerated very well.

People with T1DM often develop hyperglycemia from emotional stress or medical stress. Automated closed-loop systems should be able to detect such changes in insulin sensitivity and adapt insulin delivery accordingly. We recently verified the adaptability of a model-based closed-loop system in which the gain factors that govern a proportional-integral-derivative-like system are adjusted according to frequently measured insulin sensitivity. Automated systems can be tested by physical exercise to increase glucose uptake and insulin sensitivity or by administering corticosteroids to reduce insulin sensitivity.

Another source of risk in closed-loop systems is suboptimal performance of amperometric glucose sensors. Inaccuracy can result from calibration error, biofouling, and current drift. We found that concurrent use of more than one sensor typically leads to better sensor accuracy than use of a single sensor. For example, using the average of two sensors substantially reduces the proportion of large sensor errors. The use of more than two allows the use of voting algorithms, which can temporarily exclude a sensor whose signal is outlying.

Elements such as the use of glucagon to minimize hypoglycemia, adaptation to changes in insulin sensitivity, and sensor redundancy will likely increase safety during outpatient use of closed-loop glycemic control systems.
Hemoglobin A1c Testing in an Emergency Department
Authors: Magee Michelle F. , Nassar Carine
Published: January 2014

Background:

Emergency department (ED) visits for hyperglycemia are common and costly. Enhanced strategies for recognizing and managing patients with diabetes in the ED are needed. Hemoglobin A1c (A1C) testing is typically used to assess level of glycemic control in the 2–3 months preceding an office visit. In this article, we report on potential roles for point-of-care (POC) A1C testing in the ED for patients presenting with uncontrolled hyperglycemia.

Methods:

We enrolled patients presenting to an urban tertiary care hospital ED with blood glucose (BG) ≥200 mg/dl who were otherwise stable for discharge ( n = 86) in a prospective, nonrandomized pilot study. Antihyperglycemic medication management, survival-skills diabetes self-management education, and health system navigation were provided. Followup visits took place at 24–72 hours and at 2 and 4 weeks. Point-of-care A1C testing was performed at baseline and at 2 weeks. Baseline A1C results were used by the ED physician and the educator to inform the patient of likely preadmission glycemic classification, and the potential role that the (diabetes mellitus) DM medication regimen assigned in the ED had in enabling overall progress in glycemic control at 2 weeks post-ED initiation of treatment.

Results:

At baseline, 50% of POC A1C values were >13%. Mean BG fell from 356 ± 110 mg/dl to 183 ± 103 mg/dl at 4 weeks (average decrease of 173.5 g/dl, p < 0.001). Mean A1C fell by 0.4%, from 12.0 ± 1.5% to 11.6 ± 1.6% at 2 weeks, p = 0.048. There were zero instances of day 1 hypoglycemia and overall hypoglycemia rates were low (1.3%).

Conclusions:

Point-of-care A1C testing in the ED helped inform both the provider and the patient of likely prior glycemic status, including unrecognized or uncontrolled type 2 diabetes, and allowed emphasis of the importance of timely diabetes self-management education and medication management in preventing acute and chronic complications. Followup POC A1C testing at 2 weeks was used to confirm early improvement in glycemic control postintervention.
The Effect of an Instant Hand Sanitizer on Blood Glucose Monitoring Results
Authors: Mahoney John J. , Ellison John M. , Glaeser Danielle , Price David
Published: January 2014

Background:

People with diabetes mellitus are instructed to clean their skin prior to self-monitoring of blood glucose to remove any dirt or food residue that might affect the reading. Alcohol-based hand sanitizers have become popular when soap and water are not available. The aim of this study was to determine whether a hand sanitizer is compatible with glucose meter testing and effective for the removal of exogenous glucose.

Methods:

We enrolled 34 nonfasting subjects [14 male/20 female, mean ages 45 (standard deviation, 9.4)] years, 2 with diagnosed diabetes/32 without known diabetes]. Laboratory personnel prepared four separate fingers on one hand of each subject by (1) cleaning the second finger with soap and water and towel drying (i.e., control finger), (2) cleaning the third finger with an alcohol-based hand sanitizer, (3) coating the fourth finger with cola and allowing it to air dry, and (4), coating the fifth finger with cola and then cleaning it with the instant hand sanitizer after the cola had dried. Finger sticks were performed on each prepared finger and blood glucose was measured. Several in vitro studies were also performed to investigate the effectiveness of the hand sanitizer for removal of exogenous glucose.

Results:

Mean blood glucose values from fingers cleaned with instant hand sanitizer did not differ significantly from the control finger ( p = .07 and .08, respectively) and resulted in 100% accurate results. Blood glucose data from the fourth (cola-coated) finger were substantially higher on average compared with the other finger conditions, but glucose data from the fifth finger (cola-coated then cleaned with hand sanitizer) was similar to the control finger. The data from in vitro experiments showed that the hand sanitizer did not adversely affect glucose meter results, but when an exogenous glucose interference was present, the effectiveness of the hand sanitizer on glucose bias (range: 6% to 212%) depended on the surface area and degree of dilution.

Conclusions:

In our study, use of an instant hand sanitizer was compatible with the results of a blood glucose monitor and did not affect finger stick blood glucose results. However, depending on surface area, hand sanitizers may not be adequate for cleaning the skin prior to glucose meter testing.
Basic Performance of an Enzymatic Method for Glycated Albumin and Reference Range Determination
Authors: Kohzuma Takuji , Yamamoto Tamotsu , Uematsu Yumiko , Shihabi Zak K. , Freedman Barry I.
Published: January 2014

Background:

Glycated albumin (GA) is a medium-term glycemic control marker of diabetes and may be more sensitive to changes in plasma glucose than hemoglobin A1c. We studied where and how many fructosyl groups bind to albumin, and which glycation sites are measured by the enzymatic method for GA. We also studied the basic performance of the enzymatic method for GA.

Methods:

Glycated albumin was measured using an enzymatic method (Lucica®GA-L, Asahi Kasei Pharma) on a biochemical autoanalyzer. Molecular weights of purified GA and nonglycated albumin were measured by a mass spectrometry system. Two hundred one healthy volunteers with normal results of oral glucose tolerance testing were recruited to determine the reference range in Americans.

Results:

The present method measured only glycated amino acids from albumin in serum protein. We estimate that the number of glycated amino acids measured by this method was approximately two per molecule of albumin. The general performance (sensitivity, specificity, reproducibility, linearity, interference) of the method was good. The reference range of GA% in Americans with normal glucose tolerance was determined to be 11.9–15.8% (mean ± 2 standard deviations). Significant differences were not observed between the sexes; however, race differences were observed (higher levels in blacks relative to whites).

Conclusions:

The method was specific for measuring glycated amino acids in albumin and had good basic performance characteristics. The reference range in Americans was 11.9–15.8%. This method may be a useful indicator for diabetes control.
Usefulness of Glycated Albumin Assay for Diabetes Monitoring
Authors: Little Randie R.
Published: January 2014

In this issue of Journal of Diabetes Science and Technology, Kohzuma and colleagues describe a method for measuring glycated amino acids in albumin from serum samples. This method may be useful as an alternative to hemoglobin A1c in monitoring patients with diabetes in certain situations, e.g., diabetes patients with chronic renal failure. Because there are drawbacks of each analyte for measuring glycemic status, it is important to be able to clearly define what is being measured and determine what factors might interfere with each type of measurement. Once the utility of glycated albumin measurement is clearly defined and its use is accepted for diabetes care, standardization may be warranted.
Needle with a Novel Attachment versus Conventional Screw-Thread Needles: A Preference and Ease-of-Use Test among Children and Adolescents with Diabetes
Authors: Hofman Paul , Lilleøre Søren Kruse , Ter-Borch Gitte
Published: January 2014

Background:

This usability test investigated the overall preference and usability of the novel NovoTwist® insulin pen needle versus conventional screw-thread needles, when used with Next Generation FlexPen®, in children and adolescents with diabetes.

Methods:

This was an open-label, randomized, crossover usability test in children and adolescents with type 1 diabetes who administered insulin with an insulin pen. Test needles were NovoTwist and the participant's current screw-thread needle (or NovoFine® needle). Following instruction, participants attached the needle to Next Generation FlexPen, made an injection into a foam cushion, and detached the needle. This procedure was conducted three times with both needles in a random order. Responses to 13 questions on user experience with each needle (including overall preference, ease of attachment/detachment of needle/cap, handling, learning, confidence in attachment, and convenience of use) were subsequently recorded on a six-point rating scale (1 = very difficult; 6 = very easy).

Results:

Fifteen children aged ≥6 to ≤12 years and 15 adolescents aged ≥13 to ≤17 years participated in the test. A significantly higher proportion of children and adolescents (77%) indicated that they would prefer to use NovoTwist compared with screw-thread needles ( p = .005). NovoTwist was preferred by most children and adolescents for overall ease of use (77%; p = .005), for ease of attachment (87%; p < .001) and detachment (83%; p < .001), and as the most appropriate needle to handle for daily injections (73%; p = .016). The mean rating for confidence in correct needle attachment was not significantly different between the two needle types. Seven out of eight parents of children who required assistance for their daily insulin injections stated that they would be “very likely” to allow their child to attach NovoTwist.

Conclusions:

These factors may promote confidence in this needle, and thus in self-injecting, among younger patients and their parents.
A Spectrum of Dynamic Insulin Sensitivity Test Protocols
Authors: Docherty Paul D. , Chase J. Geoffrey , Morenga Lisa Te , Lotz Thomas F. , Berkeley Juliet E. , Shaw Geoffrey M. , McAuley Kirsten A. , Mann Jim I.
Published: January 2014

Background:

Numerous tests have been developed to estimate insulin sensitivity ( SI). However, most of the established tests are either too expensive for widespread application or do not yield reliable results. The dynamic insulin sensitivity and secretion test (DISST) uses assays of glucose, insulin, and C-peptide from nine samples to quantify SI and endogenous insulin secretion ( UN) at a comparatively low cost. The quick dynamic insulin sensitivity test has shown that the DISST SI values are robust to significant assay omissions.

Methods:

Eight DISST-based variations of the nine-sample assay regimen are proposed to investigate the effects of assay omission within the DISST-based framework. SI and UN were identified using the fully-sampled DISST and data from 218 nine-sample tests undertaken in 74 female individuals with elevated diabetes risk. This same data was then used with appropriate assay omissions to identify SI and UN with the eight DISST-based assay variations.

Results:

Median intraprocedure proportional difference between SI values from fully-sampled DISST and the DISST-based variants was in the range of −17.9 to 7.8%. Correlations were in the range of r = 0.71 to 0.92 with the highest correlations between variants with the greatest commonality with the nine-sample DISST. Metrics of UN correlated relatively well between tests when C−peptide was assayed ( r = 0.72 to 1) but were sometimes not well estimated when samples were not assayed for C-peptide ( r = −0.14 to 0.75).

Conclusions:

The DISST-based spectrum offers a series of tests with very distinct compromises of information yield, accuracy, assay cost, and clinical intensity. Thus, the spectrum of tests has the potential to enable researchers to better allocate funds by selecting an optimal test configuration for their particular application.
Is There a Relationship between Mean Blood Glucose and Glycated Hemoglobin?
Authors: Makris Konstantinos , Spanou Loukia
Published: January 2014

Measurement of hemoglobin A1c (HbA1c) is considered the gold standard for monitoring chronic glycemia of diabetes patients. Hemoglobin A1c indicates an average of blood glucose levels over the past 3 months. Its close association with the risk for the development of long-term complications is well established. However, HbA1c does not inform patients about blood glucose values on a daily basis; therefore, frequent measurements of blood glucose levels are necessary for the day-to-day management of diabetes. Clinicians understand what HbA1c means and how it relates to glucose, but this is not the case with patients. Therefore, the translation of the HbA1c results into something more familiar to patients seemed a necessity.

The scope of this article is to review the literature to search for enough scientific evidence to support the idea of a close relationship between HbA1c and mean blood glucose (MBG), and to justify the translation of HbA1c into something that reflects the MBG.

Most studies confirm a close relationship between HbA1c and MBG, although different studies result in different linear equations. Factors affecting this relationship may limit the usefulness and applicability of a unique mathematical equation to all diabetes populations.
Precision, Accuracy, and User Acceptance of the OneTouch SelectSimple Blood Glucose Monitoring System
Authors: Philis-Tsimikas Athena , Chang Anna , Miller Lupe
Published: January 2014

Background:

The OneTouch® SelectSimple™ blood glucose monitoring system (BGMS) is a device for self-monitoring of blood glucose designed for ease of use. Alarms alert subjects to low [20–69 mg/dl (1.1–3.8 mmol/liter)], high [180–239 mg/dl (9.9–13.2 mmol/liter)], and very high [240–600 mg/dl (13.3–33.1 mmol/liter)] blood glucose readings.

Methods:

Repeatability in blood and intermediate precision with aqueous controls were examined using blood from one donor adjusted to different glucose concentrations, and tested with 10 meters and 1 test-strip lot. System accuracy was evaluated with blood samples from 100 diabetes patients tested on 3 test-strip lots, compared with a reference system (YSI 2300 STAT). To test user accuracy, patients ( n = 156) and health care professionals (HCPs) tested subject blood with the SelectSimple twice. Health care professionals evaluated subject BGMS technique after a 3–5 day home-testing period. Users evaluated the instructions for use and responded to a user acceptance questionnaire.

Results:

In repeatability and intermediate precision testing, the SelectSimple BGMS had a coefficient of variation of ≤5% or standard deviation of ≤5 mg/dl. In the clinical accuracy study, 100% of measurements <75 mg/dl (4.2 mmol/liter) were within ±15 mg/dl (0.8 mmol/liter) of reference value, and 99.6% of measurements ≥75 mg/dl (4.2 mmol/liter) were within ±20%. Patients were able to use the BGMS appropriately and evaluated it as easy to use. Acceptance of the SelectSimple BGMS was within predefined limits.

Conclusions:

In these studies, the SelectSimple BGMS met all criteria for precision, system, and user accuracy, was easy to use, and was well accepted by patients.
Evaluation of the Analytical Performance of the Coulometry-Based Optium Omega Blood Glucose Meter
Authors: Solnica Bogdan , Kusnierz-Cabala Beata , Slowinska-Solnica Krystyna , Witek Przemyslaw , Cempa Agnieszka , Malecki Maciej T.
Published: January 2014

Background:

The goal of diabetes treatment is maintaining near normoglycemia based on self-monitoring of blood glucose (SMBG). In this study, an evaluation of the analytical performance of the coulometry-based Optium Omega™ glucose meter designed for SMBG has been carried out.

Methods:

The assessment of precision and between-lot variability was based on glucose measurements in ethylenediaminetetraacetic acid venous blood samples. Glucose concentrations measured in 289 fresh capillary blood samples using the Omega glucose meter and the Biosen C_line analyzer were compared.

Results:

Within-run imprecision coefficient of variation for the lower and higher glucose concentrations amounted to 5.09 and 2.1%, respectively. The relative lot-dependent differences found for the lower and higher glucose concentrations were equal to 6.8 and 2.6%, respectively. The glucose meter error calculated for various concentration ranges amounted from 2.22 to 4.48%. The glucose meter error met the accuracy criteria recommended by the International Organization for Standardization and the American Diabetes Association. The Passing-Bablok agreement test and error grid analysis with 96% of results in zone A indicated good concordance of results, including glucose concentrations below 100 mg/dl.

Conclusions:

The evaluated Optium Omega glucose meter fits the analytical requirements for its use in blood glucose monitoring in diabetes patients.
Stochastic Targeted (STAR) Glycemic Control: Design, Safety, and Performance
Authors: Evans Alicia , Le Compte Aaron , Tan Chia-Siong , Ward Logan , Steel James , Pretty Christopher G. , Penning Sophie , Suhaimi Fatanah , Shaw Geoffrey M. , Desaive Thomas , Chase J. Geoffrey
Published: January 2014

Introduction:

Tight glycemic control (TGC) has shown benefits but has been difficult to achieve consistently. STAR (Stochastic TARgeted) is a flexible, model-based TGC approach that directly accounts for intra- and interpatient variability with a stochastically derived maximum 5% risk of blood glucose (BG) below 72 mg/dl. This research assesses the safety, efficacy, and clinical burden of a STAR TGC controller modulating both insulin and nutrition inputs in virtual and clinical pilot trials.

Methods:

Clinically validated virtual trials using data from 370 patients in the SPRINT (Specialized Relative Insulin and Nutrition Titration) study were used to design the STAR protocol and test its safety, performance, and required clinical effort prior to clinical pilot trials. Insulin and nutrition interventions were given every 1–3 h as chosen by the nurse to allow them to manage workload. Interventions were designed to maximize the overlap of the model-predicted (5–95th percentile) range of BG outcomes with the 72–117 mg/dl band and thus provide a maximum 5% risk of BG <72 mg/dl. Interventions were calculated using clinically validated computer models of human metabolism and its variability in critical illness. Carbohydrate intake (all sources) was selected to maximize intake up to 100% of the American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) goal (25 kg/kcal/h). Insulin doses were limited (8 U/h maximum), with limited increases based on current rate (0.5–2.0 U/h). Initial clinical pilot trials involved 3 patients covering ~450 h. Approval was granted by the Upper South A Regional Ethics Committee.

Results:

Virtual trials indicate that STAR provides similar glycemic control performance to SPRINT with 2–3 h (maximum) measurement intervals. Time in the 72–126 mg/dl and 72–145 mg/dl bands was equivalent for all controllers, indicating that glycemic outcome differences between protocols were only shifted in this range. Safety from hypoglycemia was improved. Importantly, STAR using 2–3 h (maximum) intervention intervals reduced clinical burden up to 30%, which is clinically very significant. Initial clinical trials showed glycemic performance, safety, and management of inter- and intrapatient variability that matched or exceeded the virtual trial results.

Conclusions:

In virtual trials, STAR TGC provided tight control that maximized the likelihood of BG in a clinically specified glycemic band and reduced hypoglycemia with a maximum 5% (or lower) expected risk of light hypoglycemia (BG <72 mg/dl) via model-based management of intra- and interpatient variability. Clinical workload was self-managed and reduced up to 30% compared with SPRINT. Initial pilot clinical trials matched or exceeded these virtual results.
Use of an Automated Bolus Calculator Reduces Fear of Hypoglycemia and Improves Confidence in Dosage Accuracy in Patients with Type 1 Diabetes Mellitus Treated with Multiple Daily Insulin Injections
Authors: Barnard Katharine , Parkin Christopher , Young Amanda , Ashraf Mansoor
Published: January 2014

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.
Intraoperative Fluorescence Vascular Angiography: During Tibial Bypass
Authors: Perry Diana , Bharara Manish , Armstrong David G. , Mills Joseph
Published: January 2014

Preventing amputations in persons with lower extremity complications of diabetes is a complex endeavor, particularly in those with concomitant ischemia and tissue loss. Fluorescence angiography (Novadaq SPY system) may provide a tool for objective evaluations of tissue viability in the diabetic foot, which is an important indicator of the ability of the diabetic ulcer to heal adequately. The SPY system uses a low-power laser coupled with a charge-coupled device camera and indocyanine green (ICG) to sequence perfusion at the surface of the skin. We present an illustrated example of the potential utility of ICG fluorescence angiography (ICGFA) before and after vascular intervention in a high-risk limb. ICGFA appeared to reveal demarcation between viable and nonviable tissue and real-time perfusion, specifically capillary fill. ICGFA clarified the extent of necessary debridement and provided an immediate indication of improvement in regional perfusion status following revascularization. Future studies involving ICGFA may include pre- and postdebridement and closure perfusion, comparison of tissue perfusion pre- and post-endovascular therapy, and lower extremity flap viability. Future works will also address the consistency of results with ICGFA by analyzing a larger cohort of patients being treated by our unit.
Plantar Fascia Thickness is Longitudinally Associated with Retinopathy and Renal Dysfunction: A Prospective Study from Adolescence to Adulthood
Authors: Benitez-Aguirre Paul Z. , Craig Maria E. , Jenkins Alicia J. , Gallego Patricia H. , Cusumano Janine , Duffin Anthony C. , Hing Stephen , Donaghue Kim C.
Published: January 2014

Aim:

The aim was to study the longitudinal relationship between plantar fascia thickness (PFT) as a measure of tissue glycation and microvascular (MV) complications in young persons with type 1 diabetes (T1DM).

Methods:

We conducted a prospective longitudinal cohort study of 152 (69 male) adolescents with T1DM who underwent repeated MV complications assessments and ultrasound measurements of PFT from baseline (1997–2002) until 2008. Retinopathy was assessed by 7-field stereoscopic fundal photography and nephropathy by albumin excretion rate (AER) from three timed overnight urine specimens. Longitudinal analysis was performed using generalized estimating equations (GEE).

Results:

Median (interquartile range) age at baseline was 15.1 (13.4–16.8) years, and median follow-up was 8.3 (7.0–9.5) years, with 4 (3–6) visits per patient. Glycemic control improved from baseline to final visit [glycated hemoglobin (HbA1c) 8.5% to 8.0%, respectively; p = .004]. Prevalence of retinopathy increased from 20% to 51% ( p < .001) and early elevation of AER (>7.5 μg/min) increased from 26% to 29% ( p = .2). A greater increase in PFT (mm/year) was associated with retinopathy at the final assessment (ΔPFT 1st vs. 2nd-4th quartiles, χ2 = 9.87, p = .02). In multivariate GEE, greater PFT was longitudinally associated with retinopathy [odds ratio (OR) 4.6, 95% confidence interval (CI) 2.0–10.3] and early renal dysfunction (OR 3.2, CI 1.3–8.0) after adjusting for gender, blood pressure standard deviation scores, HbA1c, and total cholesterol.

Conclusions:

In young people with T1DM, PFT was longitudinally associated with retinopathy and early renal dysfunction, highlighting the importance of early glyccmic control and supporting the role of metabolic memory in MV complications. Measurement of PFT by ultrasound offers a noninvasive estimate of glyccmic burden and tissue glycation.
Interindividual and Intraindividual Variations in Postprandial Glycemia Peak Time Complicate Precise Recommendations for Self-Monitoring of Glucose in Persons with Type 1 Diabetes Mellitus
Authors: Johansen Mette Dencker , Gjerløv Irene , Christiansen Jens Sandahl , Hejlesen Ole K.
Published: January 2014

Background:

In glycemic control, postprandial glycemia may be important to monitor and optimize as it reveals glycemic control quality and postprandial hyperglycemia partly predicts late diabetic complications. Self-monitoring of blood glucose (SMBG) may be an appropriate technology to use, but recommendations on measurement time are crucial.

Method:

We retrospectively analyzed interindividual and intraindividual variations in postprandial glycemic peak time. Continuous glucose monitoring (CGM) and carbohydrate intake were collected in 22 patients with type 1 diabetes mellitus. Meals were identified from carbohydrate intake data. For each meal, peak time was identified as time from meal to CGM zenith within 40–150 min after meal start. Interindividual (one-way Anova) and intraindividual (intraclass correlation coefficient) variation was calculated.

Results:

Nineteen patients were included with sufficient meal data quality. Mean peak time was 87 ± 29 min. Mean peak time differed significantly between patients ( p = 0.02). Intraclass correlation coefficient was 0.29.

Conclusions:

Significant interindividual and intraindividual variations exist in postprandial glycemia peak time, thus hindering simple and general advice regarding postprandial SMBG for detection of maximum values.
Analysis and Perspective: Comparison of Insulin Diluent Leakage Post-Injection Using Two Different Needle Lengths and Injection Volumes in Obese Patients with Type 1 or Type 2 Diabetes Mellitus
Authors: Bailey Timothy S.
Published: January 2014

The effects of needle gauge and length on the efficacy and tolerability of insulin injection therapy are becoming better understood. This analysis discusses some of these effects and comments on a new study by Ignaut and Fu in this issue of Journal of Diabetes Science and Technology on the effects of needle length on insulin diluent leakage from injection sites.
Comparison of Known Food Weights with Image-Based Portion-Size Automated Estimation and Adolescents' Self-Reported Portion Size
Authors: Lee Christina D. , Chae Junghoon , Schap TusaRebecca E. , Kerr Deborah A. , Delp Edward J. , Ebert David S. , Boushey Carol J.
Published: January 2014

Background:

Diet is a critical element of diabetes self-management. An emerging area of research is the use of images for dietary records using mobile telephones with embedded cameras. These tools are being designed to reduce user burden and to improve accuracy of portion-size estimation through automation. The objectives of this study were to (1) assess the error of automatically determined portion weights compared to known portion weights of foods and (2) to compare the error between automation and human.

Methods:

Adolescents ( n = 15) captured images of their eating occasions over a 24 h period. All foods and beverages served were weighed. Adolescents self-reported portion sizes for one meal. Image analysis was used to estimate portion weights. Data analysis compared known weights, automated weights, and self-reported portions.

Results:

For the 19 foods, the mean ratio of automated weight estimate to known weight ranged from 0.89 to 4.61, and 9 foods were within 0.80 to 1.20. The largest error was for lettuce and the most accurate was strawberry jam. The children were fairly accurate with portion estimates for two foods (sausage links, toast) using one type of estimation aid and two foods (sausage links, scrambled eggs) using another aid. The automated method was fairly accurate for two foods (sausage links, jam); however, the 95% confidence intervals for the automated estimates were consistently narrower than human estimates.

Conclusions:

The ability of humans to estimate portion sizes of foods remains a problem and a perceived burden. Errors in automated portion-size estimation can be systematically addressed while minimizing the burden on people. Future applications that take over the burden of these processes may translate to better diabetes self-management.
Monitoring Methods for Dogs and Cats with Diabetes Mellitus
Authors: Cook Audrey K. ,   Dip. ACVIM-SAIM, Dip. ECVIM-CA
Published: January 2014

Effective monitoring is essential for the management of dogs and cats with diabetes mellitus. However, methods for evaluating glycemic control must be tailored to meet both the needs of the patient and the expectations of the owner. This article discusses the philosophies that drive blood glucose monitoring in veterinary diabetics and review common practices. The advantages and limitations of the various options are presented.
Upregulation of Proinflammatory Cytokine Production in Response to Bacterial Pathogen-Associated Molecular Patterns in Dogs with Diabetes Mellitus Undergoing Insulin Therapy
Authors: DeClue Amy E. , Nickell Jordan , Chang Chee-Hoon , Honaker Allison
Published: January 2014

Background:

Metabolic alterations associated with diabetes mellitus alter innate immunity. Dogs often develop infectious or inflammatory complications related to diabetes mellitus, yet little is known about the effects of diabetes mellitus on the immune system in this species.

Methods:

Prospective evaluation in dogs with poorly regulated spontaneous type 1 diabetes mellitus (T1DM). In vitro leukocyte cytokine response to lipopolysaccharide (LPS), lipoteichoic acid (LTA), and peptidoglycan (PG) was compared between dogs with T1DM and healthy dogs. Additionally, the effect of acute in vitro glucose exposure on leukocyte tumor necrosis factor (TNF) production from healthy dogs was measured.

Results:

Leukocytes from dogs with T1DM had significantly greater TNF production after LTA and PG stimulation compared with leukocytes from healthy dogs. Leukocyte interleukin (IL)-6 production was greater after stimulation with LPS, LTA, PG, and phosphate-buffered saline in the T1DM group. No such difference was noted when evaluating IL-10 production between groups regardless of stimulant. Dogs with T1DM had significantly greater IL-6 to IL-10 production ratios than healthy dogs. Acute exposure to dextrose did not augment cytokine production from healthy canine leukocytes.

Conclusions:

Dogs with T1DM have altered innate immunity characterized by upregulation of proinflammatory cytokine production without a concurrent change in anti-inflammatory cytokine production. This may be one explanation for the common infectious and inflammatory complications associated with T1DM in dogs.
Association between Sitagliptin Adherence and Self-Monitoring of Blood Glucose
Authors: Nigam Somesh , Virdi Naunihal S. , Daskiran Mehmet , Kozma Chris M. , Paris Andrew , Dickson William M.
Published: January 2014

Background:

We evaluated the association between self-monitoring of blood glucose (SMBG) use and sitagliptin or sitagliptin/ metformin (SSMT) adherence. SSMT was chosen as these medications have little risk of hypoglycemia and are believed to not require SMBG data for titration.

Methods:

This was an observational study using data extracted from a large United States insurance claims database (i3 InVision™ Data Mart, Ingenix, Inc.). Data were extracted on noninsulin-using patients initiating SSMT for each 12-month period pre- and post-SSMT initiation. Logistic regression was used to assess the relationship between SMBG use and the likelihood of being medication adherent (defined as a medication possession ratio of ≥75%) while controlling for covariates.

Results:

This analysis included 7,306 patients (57.6% male; mean age 54.2 years). Mean pre-SSMT hemoglobin A1c (HbA1c) was 8.0%. In the post-SSMT initiation period, 58% of patients were adherent with SSMT. Older age, male gender, prior use of oral diabetes medication, and lower HbA1c were associated with improved SSMT adherence. SMBG use was associated with improved adherence [odds ratio (OR) ranged from 1.198 to 1.338; p < .05] compared with patients with no SMBG use pre- or post-SSMT initiation. For patients who began SMBG after starting SSMT, greater SMBG use was associated with better adherence (OR 1.449 for higher vs 1.246 for lower strip use; p < .05).

Conclusions:

This study demonstrated that SMBG is associated with improved SSMT adherence. This relationship is strengthened with greater SMBG use.
Retinal Vascular Geometry in Asian Persons with Diabetes and Retinopathy
Authors: Cheung Carol Yim-Lui , Lamoureux Ecosse , Ikram M. Kamran , Sasongko M. Bayu , Ding Jie , Zheng Yingfeng , Mitchell Paul , Wang Jie Jin , Wong Tien Yin
Published: January 2014

Purpose:

Our purpose was to examine the relationship of retinal vascular parameters with diabetes and retinopathy in an older Asian population.

Methods:

Retinal photographs from participants of a population-based survey of Asian Malay persons aged 40–80 years were analyzed. Specific retinal vascular parameters (tortuosity, branching angle, fractal dimension, and caliber) were measured using a semiautomated computer-based program. Diabetes was defined as random plasma glucose = 11.1 mmol/liter, the use of diabetes medication, or physician-diagnosed diabetes. Retinopathy signs were graded from photographs using the modified Airlie House classification system.

Results:

A total of 2735 persons were included in the study. Persons with diabetes ( n = 594) were more likely to have straighter (less tortuous) arterioles and wider arteriolar and venular caliber than those without diabetes ( n = 2141). Among subjects with diabetes, those with retinopathy had wider venular caliber than those without retinopathy (211.3 versus 204.9 μm, p = .001). Among nondiabetic subjects, however, those with retinopathy had more tortuous venules than those without retinopathy [5.19(x104) versus 4.27(x104), p < .001].

Conclusions:

Retinal vascular parameters varied by diabetes and retinopathy status in this older Asian cohort. Our findings suggest that subtle alterations in retinal vascular architecture are influenced by diabetes.
The Role of Self-Monitoring of Blood Glucose in Glucagon-like Peptide-1-Based Treatment Approaches: A European Expert Recommendation
Authors: Schnell Oliver , Alawi Hasan , Battelino Tadej , Ceriello Antonio , Diem Peter , Felton Anne-Marie , Grzeszczak Wladyslaw , Harno Kari , Kempler Peter , Satman Ilhan , Vergès Bruno
Published: January 2014

The role of glucagon-like peptide (GLP)-1-based treatment approaches for type 2 diabetes mellitus (T2DM) is increasing. Although self-monitoring of blood glucose (SMBG) has been performed in numerous studies on GLP-1 analogs and dipeptidyl peptidase-4 inhibitors, the potential role of SMBG in GLP-1-based treatment strategies has not been elaborated. The expert recommendation suggests individualized SMBG strategies in GLP-1-based treatment approaches and suggests simple and clinically applicable SMBG schemes. Potential benefits of SMBG in GLP-1-based treatment approaches are early assessment of treatment success or failure, timely modification of treatment, detection of hypoglycemic episodes, assessment of glucose excursions, and support of diabetes management and diabetes education. Its length and frequency should depend on the clinical setting and the quality of metabolic control. It is considered to play an important role for the optimization of diabetes management in T2DM patients treated with GLP-1-based approaches.