bluuebunny/crossref_metadata_2025 huggingface dataset:
Continuous Noninvasive Glucose Monitoring Technology Based on “Occlusion Spectroscopy”
Authors: Amir Orna , Weinstein Daphna , Zilberman Silviu , Less Malka , Perl-Treves Daniele , Primack Harel , Weinstein Aharon , Gabis Efi , Fikhte Boris , Karasik Avraham
Published: January 2014

Background:

A truly noninvasive glucose-sensing device could revolutionalize diabetes treatment by leading to improved compliance with recommended glucose levels, thus reducing the long-term complications and cost of diabetes. Herein, we present the technology and evaluate the efficacy of a truly noninvasive device for continuous blood glucose monitoring, the NBM (OrSense Ltd.).

Methods:

In vitro analysis was used to validate the technology and algorithms. A clinical study was performed to quantify the in vivo performance of the NBM device. A total of 23 patients with type 1 (n = 12) and type 2 (n = 11) diabetes were enrolled in the clinical study and participated in 111 sessions. Accuracy was assessed by comparing NBM data with paired self-monitoring of blood glucose meter readings.

Results:

In vitro experiments showed a strong correlation between calculated and actual glucose concentrations. The clinical trial produced a total of 1690 paired glucose values (NBM vs reference). In the paired data set, the reference glucose range was 40–496 mg/dl. No systematic bias was found at any of the glucose levels examined (70, 100, 150, and 200 mg/dl). The mean relative absolute difference was 17.2%, and a Clarke error grid analysis showed that 95.5% of the measurements fall within the clinically acceptable A&B regions (zone A, 69.7%; and zone B, 25.7%).

Conclusions:

This study indicates the potential use of OrSense's NBM device as a noninvasive sensor for continuous blood glucose evaluation. The device was safe and well tolerated.
Prediction Capability of Optical Coherence Tomography for Blood Glucose Concentration Monitoring
Authors: Kuranov Roman V. , Sapozhnikova Veronika V. , Prough Donald S. , Cicenaite Inga , Esenaliev Rinat O.
Published: January 2014

Background:

Optical coherence tomography (OCT) has been shown to be a promising optical approach to noninvasive monitoring of blood glucose concentration because of its capability of probing optical properties at different depths in tissue with high resolution. This article investigates the capability of OCT to predict changes in blood glucose concentration.

Methods:

We varied blood glucose concentration in the physiological range in three sets of experiments. In the first set, we investigated large variations of blood glucose concentration (=400 mg/dl) and used 2100 OCT A scans for signal averaging. In the second set, we varied blood glucose concentration by approximately 200 mg/dl and used 8400 A scans for signal averaging. In the third set, we improved OCT blood glucose monitoring by increasing and controlling skin temperature under the OCT probe. In this set of experiments we increased the glucose concentration by approximately 300 mg/dl and used 4200 A scans for averaging.

Results:

The predicted glucose concentrations in the first two sets were lower than actual glucose concentration by 10–20% (the mean shift), while the heating and temperature control in the third set of experiments reduced the mean shift down to 1.5%. Therefore, the mean shift was reduced substantially by tissue heating and temperature control. However, it did not depend on the number of A scans to be averaged. In contrast, the uncertainty in OCT prediction of glucose concentration (the standard deviation) did not depend on heating and temperature control, but was reduced substantially from 56 to 24 mg/dl by increasing the number of A scans from 2100 to 8400, respectively.

Conclusion:

These results suggest that the accuracy of OCT-based glucose monitoring is approaching that of standard invasive and minimally invasive techniques.
Accuracy of Digital Images for Assessing Diabetic Retinopathy
Authors: Kim Hyungjin Myra , Lowery Julie C. , Kurtz Ronald
Published: January 2014

Background:

To determine the accuracy of diabetic retinopathy status assessments with and without pupil dilation using digital fundus photographs acquired by a clinic staff person and interpreted remotely by ophthalmologists.

Method:

Using early treatment diabetic retinopathy study (EDTRS) grading criteria, diabetic retinopathy status assessments were made by an experienced (nonphysician) retinal grader (NPG) based on seven standard field 35-mm stereoscopic slides acquired by an experienced ophthalmic photographer. These assessments were compared with those of the same eyes made by two ophthalmologists and the NPG using digital photographs acquired by a clinic staff person using a high-resolution (800 × 600) digital color camera system.

Results:

Based on 35-mm slides, 38% of 244 diabetic patients had ETDRS >35 in at least one eye and 5% had vision-threatening diabetic retinopathy (ETDRS >53 or macular edema). The proportion of ungradable images was significantly greater for nonmydriatic than mydriatic assessments (30% versus 10% ungradable as determined by the NPG). For ETDRS level >35, specificity ranged from moderate to high (0.70 to 0.96) for the three graders, while sensitivity was poor to moderate (0.38 to 0.71), and the area under the receiver-operating characteristic curves was less than satisfactory (0.67 to 0.71).

Conclusions:

The low sensitivity of the digital assessments indicates a significant proportion of patients in need of referral would not have been referred. These findings suggest that implementation of a simplified screening system using nonphotographer clinic staff acquiring nonmydriatic images, with interpretation by an ophthalmologist, should take place with an understanding of potential limitations.
Treat-to-Target Insulin Titration Algorithms When Initiating Long or Intermediate Acting Insulin in Type 2 Diabetes
Authors: Strange Poul
Published: January 2014

Background:

Until recently, titration of insulin in type 2 diabetes clinical trials was typically left up to the investigator's discretion with a simple statement of the target ranges for glucose. In type 2 diabetes trials the average glycemic control achieved was usually less than desirable. Since then a number of trials have been conducted and reported utilizing various algorithms under various conditions. The objective of this article is to provide a review of the evidence to date.

Methods:

In addition to studies already identified through work in the area, the literature was searched using PubMed with the search words “insulin and titration” and subsequently “insulin and algorithm” from which studies starting insulin therapy using insulin titration algorithms in type 2 diabetes were selected.

Results:

The different algorithms and achieved results for glycemic control and hypoglycemia, as well as factors appearing to impact the results, are reviewed.

Conclusion:

The recent introduction of rigorously implemented insulin titration algorithms when adding on basal insulin to oral drugs in inadequately treated type 2 diabetes patients has led to better average glycemic control with little risk of severe hypoglycemia, as long as the morning fasting plasma glucose target is not lower than 100 mg/dl. Insulin titration algorithms have undergone and continue evolution in the direction of increased patient control.
Safety of the Ullorex® Oral Intragastric Balloon for the Treatment of Obesity
Authors: Martin Corby K. , Bellanger Drake E. , Rau Kristina K. , Coulon Sandra , Greenway Frank L.
Published: January 2014

Background:

Intragastric balloons have been used for weight loss with varying success. Widespread use of intragastric balloons has been limited because balloons must be placed in, and removed from, the stomach endoscopically. Development of a balloon that does not require endoscopy suggests that obesity treatment with intragastric balloons is feasible. The purpose of this study was to test the Ullorex® oral intragastric balloon (OIB) in a sample of human participants.

Methods:

The Ullorex OIB is a large capsule that is injected with citric acid and swallowed. After 4 minutes, the balloon inflates to 300 cm3. Stomach acid degrades a plug on the balloon over 25–30 days, when the balloon deflates and passes in feces. The Ullorex OIB was tested in 12 humans (two participants received placebo capsules). Body weight was monitored before and after balloon placement, and test meals quantified food intake among 6 of the 12 participants, all of whom received one balloon.

Results:

A single significant adverse event occurred. The one participant randomized to receive three balloons developed nausea and vomiting, requiring intravenous fluids, which was likely influenced by noncompliance (eating solid foods after balloon placement). Participants who received balloons had a significant mean weight loss over 2 weeks, amounting to 1.5 kg (p < 0.05). A marginally significant food intake reduction from baseline to week 1 was found (149 kcal, 24.4%) ( p = 0.055).

Conclusions:

The Ullorex OIB was successfully utilized in this study, with one serious adverse event that was likely influenced by noncompliance. Body weight and food intake data suggest that the Ullorex OIB be tested further as a possible treatment for obesity.
Randomized Studies are Needed to Assess the True Role of Self-Monitoring of Blood Glucose in Noninsulin-Treated Type 2 Diabetes
Authors: Parkin Christopher G. , Price David
Published: January 2014

Numerous trials have been conducted to assess the utility of self-monitoring of blood glucose (SMBG) in noninsulin-treated type 2 diabetic (T2DM) patients. Although recent meta-analyses support the benefits of SMBG, the clinical utility of SMBG in this population remains controversial due to a lack of large, randomized controlled trials. Much of the skepticism regarding SMBG in noninsulin-treated T2DM may stem from a misapplication or misunderstanding of the true role of SMBG. The benefits of SMBG are realized only when both the patient and the health care provider (HCP) know how and are willing to monitor, interpret, and respond appropriately to acute glucose excursions and patterns of glycemia identified through SMBG. Optimal utilization of SMBG requires that patients be trained and motivated to accurately perform SMBG at the time and frequency prescribed, accurately interpret the data they obtain, act upon the information when appropriate, and consistently document results for later review with their HCP. HCPS must be willing and able to routinely monitor SMBG data and make appropriate adjustments in therapy. Numerous studies are needed to evaluate the true value and utility of SMBG within the diverse T2DM population to ensure that resources for diabetes management can be used efficiently. This article identifies and discusses key factors to consider for the design of randomized studies that can provide a foundation upon which HCPs and health care systems may reevaluate their current strategies/protocols and incorporate the learnings into more effective approaches to patient care.
Hypoglycemia Detection and Prediction Using Continuous Glucose Monitoring—A Study on Hypoglycemic Clamp Data
Authors: Palerm Cesar C. , Bequette B. Wayne
Published: January 2014

Motivation:

The fear of hypoglycemia remains an important limiting factor in the ability of an individual with type 1 diabetes to tightly regulate glycemia. Continuous glucose monitors provide important feedback to improve glycemic control, but there remains a need for these devices to better alarm of possible impending hypoglycemia, particularly overnight or other periods when the individual is engaged in activities that take their focus away from glucose monitoring.

Methods:

We have previously proposed an algorithm, based on the use of real-time glucose sensor signals and optimal estimation theory (Kalman filtering), to predict hypoglycemia; the algorithm was validated in simulation-based studies. In this article we further refine and validate the prediction algorithm based on the analysis of clinical hypoglycemic clamp data from 13 subjects. The sensitivity and specificity of the predictions are calculated with respect to reference blood glucose values obtained at the same sampling rate of the sensor.

Results:

For a 30-minute prediction horizon and alarm threshold of 70 mg/dl, the sensitivity and specificity were 90 and 79%, respectively, indicating that a 21% false alarm rate must be tolerated to predict 90% of the hypoglycemic events 30 minutes ahead of time. Shorter prediction horizons yield a significant improvement in sensitivity and specificity.

Discussion:

Sensitivity and specificity data as a function of prediction horizon and alarm threshold enable an individual to adjust the alarm to best meet their needs. Such decisions can be made depending on the subject's risk for hypoglycemia, for example.
Use of Fourier Models for Analysis and Interpretation of Continuous Glucose Monitoring Glucose Profiles
Authors: Miller Michael , Strange Poul
Published: January 2014

Background:

The introduction of continuous glucose monitoring (CGM) devices has dramatically increased the amount of information available about each patient. While CGM has become a useful diagnostic tool for the individual patient, interpretive issues including noise reduction remain and further analytical work is needed to fully utilize the data richness.

Method:

We applied discrete Fourier transform methodology to CGM data to obtain an overall statistical model providing the dimension reduction necessary for insightful analyses of the whole function and explored some properties and possible applications of this technology.

Results:

The following example applications are shown. Discrete Fourier transform allows reduction of noise using an objective statistical criterion and may, as a first step, possibly enhance the value of various measures of variability through this noise reduction. Average functions of groups in a prospective randomized clinical are demonstrated and the aggregate function is readily visualized. Second and third harmonic amplitudes at baseline correlate with hemoglobin A1c after a 6-month treatment period. The time points of most rapid glucose decreases are identified easily with the functional through the second derivative, and its correlation with subsequent reported symptomatic hypoglycemia is shown.

Conclusions:

Discrete Fourier transform offers an attractive analytical methodology for CGM data given the achievable dimension reduction without loss of essential information as well as its ability to eliminate noise.
Overnight versus 24 Hours of Continuous Subcutaneous Insulin Infusion as Supplement to Oral Antidiabetic Drugs in Type 2 Diabetes
Authors: Parkner Tina , Laursen Torben , Chen Jian-Wen , Møller Marianne K. , Thomsen Henrik F. , Jørgensen Christina , Smedegaard Jørgen S. , Lauritzen Torsten , Christiansen Jens S.
Published: January 2014

Background:

Basal continuous subcutaneous insulin infusion (CSII) therapy at a fixed rate may effectively improve glycemic control in patients with type 2 diabetes when oral antidiabetic treatment fails. Regimens of simple constant subcutaneous delivery of insulin may provide theoretical advantages in type 2 diabetes.

Methods:

Ten subjects with type 2 diabetes who obtained insufficient glycemic control on oral antidiabetic drugs were included. Following an initial control day, two periods of 3 days with CSII of a rapid-acting insulin analogue, 1.5 IU/h (dose obtained from a preceding study), for 8 hours overnight and for 24 hours, respectively, were carried out in random order. Profiles of serum insulin aspart, serum endogenous insulin, and plasma glucose were recorded.

Results:

Compared to the control day, an 8-hour overnight insulin infusion during a 3-day period improved fasting plasma glucose (FPG) (mean differences ± SEM; Δ59.0 ± 10.1 mg/dl; p < 0.01) and 2-hour postprandial plasma glucose (PPPG) (Δ57.8 ± 10.6 mg/dl; p < 0.01) after breakfast. Compared to an 8-hour overnight infusion, a 24-hour infusion further improved all three PPPG values after breakfast, lunch, and dinner (Δ28.8 ± 8.1 mg/dl, Δ30.6 ± 8.1 mg/dl, and Δ35.1 ± 7.9 mg/dl; p < 0.01). During insulin infusion, only one hypoglycemic episode with PG <55.8 mg/dl and mild symptoms was recorded.

Conclusion:

Continuous subcutaneous insulin infusion with a rapid-acting insulin analogue at a fixed rate of 1.5 IU/h, either overnight or for 24 hours, improved glycemic control without safety concerns in patients with type 2 diabetes who had secondary failure to oral antidiabetic drugs. The effect on FPG was similar for both treatments, whereas the effect on PPPG was superior when insulin was infused during the entire 24 hours.
Diabetes Research in Children Network: Availability of Protocol Data Sets
Authors: Ruedy Katrina J. , Beck Roy W. , Xing Dongyuan , Kollman Craig
Published: January 2014

The Diabetes Research in Children Network (DirecNet) was established in 2001 by the National Institute of Child Health and Human Development and the National Institute of Diabetes and Digestive and Kidney Diseases through special congressional funding for type 1 diabetes research. The network consists of five clinical centers, a coordinating center, and a central laboratory. Since its inception, DirecNet has conducted nine protocols, resulting in 28 published manuscripts with an additional 2 under review and 5 in development. The protocols have involved evaluation of technology available for the treatment of type 1 diabetes, including home glucose meters (OneTouch Ultra, FreeStyle, and BD Logic), continuous glucose monitoring systems (GW2B, CGMS, FreeStyle Navigator, and Guardian RT), and hemoglobin A1c (HbA1c) devices (DCA 2000 and A1cNow). In addition, the group has conducted several studies evaluating factors affecting hypoglycemia, including exercise and bedtime snack composition. The data sets that have resulted from these studies include data from the devices being evaluated, central laboratory glucose, HbA1c and hormone data, clinical center glucose and HbA1c data, accelerometer data, and pump data depending on the procedures involved with each protocol. These data sets are, or will be, available at no charge on the study group's public Web site. Several psychosocial questionnaires developed by DirecNet are also available.
Impact of Different Fat Depots on Insulin Sensitivity: Predominant Role of Liver Fat
Authors: Kirchhoff Kerstin , Kantartzis Konstantinos , Machann Jürgen , Schick Fritz , Thamer Claus , Machicao Fausto , Fritsche Andreas , Häring Hans-Ulrich , Stefan Norbert
Published: January 2014

Background:

Overall obesity and, as it is increasingly appreciated, body fat distribution and ectopic fat deposition in liver and skeletal muscle, determine insulin resistance in humans. However, little is known about the independence of these relationships. Therefore, we determined the impact of different fat depots as well as fat accumulation in ectopic tissues such as liver and skeletal muscle in the prediction of insulin resistance in healthy humans.

Methods:

Visceral and subcutaneous abdominal fat were determined by magnetic resonance (MR) tomography and liver fat and intramyocellular fat in the tibialis anterior muscle by 1H-MR spectroscopy in 220 subjects. Insulin sensitivity was estimated from the oral glucose tolerance test (OGTT) and measured by a euglycemic hyperinsulinemic clamp in a subgroup ( n = 157).

Results:

Insulin sensitivity estimated from the OGTT correlated negatively with total body fat ( r = −0.27, p < 0.0001), subcutaneous abdominal fat ( r = −0.35, p < 0.0001), and visceral fat ( r = −0.43, p < 0.0001). Furthermore, insulin sensitivity correlated negatively with liver fat ( r = −0.53, p < 0.0001) and intramyocellular fat ( r = −0.26, p < 0.0001). In multivariate regression models, high liver and visceral fat emerged as the strongest predictors of low insulin sensitivity.

Conclusion:

Among various fat compartments, high liver fat and high visceral fat are the strongest determinants of insulin sensitivity in humans.
Vagus Nerve Stimulation and Emotional Responses to Food among Depressed Patients
Authors: Bodenlos Jamie S. , Kose Samet , Borckardt Jeffrey J. , Nahas Ziad , Shaw Darlene , O'Neil Patrick M. , Pagoto Sherry L. , George Mark S.
Published: January 2014

Background:

Approved for treatment of treatment-resistant depression and for epilepsy, vagus nerve stimulation (VNS) therapy involves stimulation of the vagus nerve, affecting both mood and appetite regulating systems. VNS is associated with changes in food intake and weight loss in animals. Studies of its impact on food intake and weight with humans are limited. It is not known whether or how VNS influences emotional response to food, but vagus afferents project to regions in the insula involving satiety and taste.

Method:

Thirty-three participants were recruited for three groups: depressed patients undergoing VNS therapy, depressed patients not undergoing VNS therapy, and healthy controls. All participants viewed images of foods twice in random order. When applicable, VNS devices were turned on for one viewing and off for the other. Participants were instructed to rate immediately after the viewings how each picture made them feel on a visual analog on three dimensions (unhappy to happy, calm to aroused, and small/submissive to big/domineering).

Results:

Controlling for time since last meal, a significant main effect was found for arousal ratings in response to sweet food images. Post-hoc analyses indicated that the VNS group demonstrated significant changes in arousal ratings between paired food image viewings compared to controls. Sixty-four percent of VNS participants demonstrated increases and 36% demonstrated decreases in arousal. Higher body mass indexes and greater levels of self-reported sweet cravings were associated with increased arousal during VNS activation.

Conclusions:

This study was the first to examine the effects of acute left cervical VNS on emotional ratings of food in adults with major depression. Results suggest that VNS device activation may be associated with acute alteration in arousal response to sweet foods among depressed patients. Future research is needed to replicate these findings and to assess how activation of the vagus nerve affects eating and weight.
A Review of Web-Assisted Interventions for Diabetes Management: Maximizing the Potential for Improving Health Outcomes
Authors: Brown Linda Lockett , Lustria Mia Liza A. , Rankins Jenice
Published: January 2014

Current endeavors in diabetes care focus on helping patients and providers deal successfully with the complexities of the disease by improving the system of care, expanding the reach of interventions, and empowering patients to engage in self-care behaviors. Internet technologies that combine the broad reach of mass media with the interactive capabilities of interpersonal media provide a wide range of advantages over standard modes of delivery. The technical affordances of Web delivery enable individualization or tailoring, appropriately timed reinforcement of educational messages, social support, improved feedback, and increased engagement. In turn, these have been significantly correlated with improved health outcomes.

This article is a narrative review of Web-based interventions for managing type 2 diabetes published from 2000 to 2007 that utilize Web sites, Web portals, electronic medical records, videoconference, interactive voice response, and short messaging systems. The most effective systems link medical management and self-management. Patient satisfaction is highest when the Web-based system gives them the ability to track blood glucose, receive electronic reminders, schedule physician visits, email their health care team, and interact with other diabetic patients. However, comprehensive medical and self-management programs have not been implemented widely outside of systems funded by government agencies. The cost of developing and maintaining comprehensive systems continues to be a challenge and is seldom measured in efficacy studies. Lack of reimbursement for Web-based treatments is also a major barrier to implementation. These barriers must be overcome for widespread adoption and realization of subsequent cost savings.
Convergence of Continuous Glucose Monitoring and In-Hospital Tight Glycemic Control: Closing the Gap between Caregivers and Industry
Authors: Miller Michaela , Skladany Matthew J. , Ludwig Christopher R. , Guthermann Joshua S.
Published: January 2014

The convergence of continuous glucose monitoring (CGM) and tight glycemic control protocols is approaching. As with the diffusion of any innovative technology, there will be challenges that will likely delay widespread adoption. With the objective of assessing the current mindset of health care professionals toward CGM adoption in the hospital intensive care unit (ICU) setting and resulting implications to industry, Boston Biomedical Consultants surveyed >60 U.S. ICU managers and nurses during Spring 2007. The underlying sentiment expressed by survey respondents toward CGM was positive, with many citing potential benefits of CGM adoption, such as labor savings, improved glycemic control, and assistance with insulin dosing. While the demand for CGM in the hospital clearly exists, early stage product acceptance will remain limited given the substantial education, market development, and economic hurdles.
In Pursuit of Change: Youth Response to Intensive Goal Setting Embedded in a Serious Video Game
Authors: Thompson Debbe , Baranowski Tom , Buday Richard , Baranowski Janice , Juliano Melissa , Frazior McKee , Wilsdon Jon , Jago Russell
Published: January 2014

Background:

Type 2 diabetes has increased in prevalence among youth, paralleling the increase in pediatric obesity. Helping youth achieve energy balance by changing diet and physical activity behaviors should decrease the risk for type 2 diabetes and obesity. Goal setting and goal review are critical components of behavior change. Theory-informed video games that emphasize development and refinement of goal setting and goal review skills provide a method for achieving energy balance in an informative, entertaining format. This article reports alpha-testing results of early versions of theory-informed goal setting and reviews components of two diabetes and obesity prevention video games for preadolescents.

Method:

Two episodes each of two video games were alpha tested with 9- to 11-year-old youth from multiple ethnic groups. Alpha testing included observed game play followed by a scripted interview. The staff was trained in observation and interview techniques prior to data collection.

Results:

Although some difficulties were encountered, alpha testers generally understood goal setting and review components and comprehended they were setting personal goals. Although goal setting and review involved multiple steps, youth were generally able to complete them quickly, with minimal difficulty. Few technical issues arose; however, several usability and comprehension problems were identified.

Conclusion:

Theory-informed video games may be an effective medium for promoting youth diabetes and obesity prevention. Alpha testing helps identify problems likely to have a negative effect on functionality, usability, and comprehension during development, thereby providing an opportunity to correct these issues prior to final production.
Comparisons of Body Volumes and Dimensions Using Three-Dimensional Photonic Scanning in Adult Hispanic-Americans and Caucasian-Americans
Authors: Olivares Josefina , Wang Jack , Yu Wen , Pereg Vicente , Weil Richard , Kovacs Betty , Gallagher Dympna , Pi-Sunyer F. Xavier
Published: January 2014

Background:

We studied whether significant differences exist between Hispanic-Americans (H-A) and Caucasian-Americans (C-A) in body dimensions using a newly validated three-dimensional photonic scanner (3DPS).

Methods:

We compared two cohorts of 34 adult U.S.-based H-A (19 females) and 40 adult C-A (25 females) of similar age and body mass index (BMI, kg/m2). We measured total body volume (TBV), trunk volume (TV), and other body dimensions, including waist and hip circumferences, estimated percentage body fat (%fat), calculated TV/TBV, and waist-to-hip ratio.

Results:

For female cohorts, there were no significant differences in age, weight, height, and 3DPS-measured variables between the two ethnic cohorts. For male cohorts, C-A had greater height ( p = 0.014), but there were no significant differences in absolute or proportional volumes or dimensions between the two cohorts.

Conclusions:

Results demonstrate that, in these H-A and C-A cohorts of similar age and BMI, total and regional body volumes and dimensions, as well as their proportions, approximate each other very closely in both sexes; these variables also show similar relationships with %fat in each sex. This is in contradistinction to previous study reports using other measurement techniques.
Harnessing Information Technologies to Improve the Delivery of Diabetes Care to Veterans: The Future is Today
Authors: Aron David C. , Pogach Leonard M.
Published: January 2014

Background:

Although momentum is now building nationally for improved informatics, progress has been incremental in most cases. One notable exception is the Veterans Health Administration, which utilizes one of the most widely used electronic medical record systems in the world.

Objectives:

The articles in this symposium demonstrate the implementation of technology to move beyond the electronic medical record at the time of the medical encounter to improve timeliness and outcomes of care delivery for veterans with diabetes.

Results:

We report on the use of electronic registries and nurse practitioner-based programs across multiple sites to improve glycemic control; the implementation of a digital retinal imaging system in primary care clinics; the use of health information technology to improve patient self-care; and the development of a research database to move beyond performance measurement to evaluate longitudinal outcomes.

Conclusions:

While these articles demonstrate the ability of a single national system of care to harness the power of technology to novel strategies for the delivery of care and its evaluation, the technology is scalable from small group practices to regional health care systems.
Building a Diabetes Registry from the Veterans Health Administration's Computerized Patient Record System
Authors: Kern Elizabeth F. O. , Beischel Scott , Stalnaker Randal , Aron David C. , Kirsh Susan R. , Watts Sharon A.
Published: January 2014

Background:

Little information is available describing how to implement a disease registry from an electronic patient record system. The aim of this report is to describe the technology, methods, and utility of a diabetes registry populated by the Veterans Health Information Systems Architecture (VistA), which underlies the computerized patient record system of the Veterans Health Administration (VHA) in Veteran Affairs Integrated Service Network 10 (VISN 10).

Methods:

VISN 10 data from VistA were mapped to a relational SQL-based data system using KB_SQL software. Operational definitions for diabetes, active clinical management, and responsible providers were used to create views of patient-level data in the diabetes registry. Query Analyzer was used to access the data views directly. Semicustomizable reports were created by linking the diabetes registry to a Web page using Microsoft asp.net2. A retrospective observational study design was used to analyze trends in the process of care and outcomes.

Results:

Since October 2001, 81,227 patients with diabetes have enrolled in VISN 10: approximately 42,000 are currently under active management by VISN 10 providers. By tracking primary care visits, we assigned 91% to a clinic group responsible for diabetes care. In the Cleveland Veterans Affairs Medical Center (VAMC), the frequency of mean annual hemoglobin A1c levels ≥9% has declined significantly over 5 years. Almost 4000 patients have been seen in diabetes intervention programs in the Cleveland VAMC over the past 4 years.

Conclusions:

A diabetes registry can be populated from the database underlying the VHA electronic patient record database system and linked to Web-based and ad hoc queries useful for quality improvement.
Teleretinal Imaging to Screen for Diabetic Retinopathy in the Veterans Health Administration
Authors: Cavallerano Anthony A. , Conlin Paul R.
Published: January 2014

Diabetes is the leading cause of adult vision loss in the United States and other industrialized countries. While the goal of preserving vision in patients with diabetes appears to be attainable, the process of achieving this goal poses a formidable challenge to health care systems. The large increase in the prevalence of diabetes presents practical and logistical challenges to providing quality care to all patients with diabetes. Given this challenge, the Veterans Health Administration (VHA) is increasingly using information technology as a means of improving the efficiency of its clinicians. The VHA has taken advantage of a mature computerized patient medical record system by integrating a program of digital retinal imaging with remote image interpretation (teleretinal imaging) to assist in providing eye care to the nearly 20% of VHA patients with diabetes. We describe this clinical pathway for accessing patients with diabetes in ambulatory care settings, evaluating their retinas for level of diabetic retinopathy with a teleretinal imaging system, and prioritizing their access into an eye and health care program in a timely and appropriate manner.
Basal—Prandial Insulin Delivery in Type 2 Diabetes Mellitus via the V-Go™: A Novel Continuous Subcutaneous Infusion Device
Authors: Kapitza Christoph , Fein Seymour , Heinemann Lutz , Schleusener Debra , Levesque Steven , Strange Poul
Published: January 2014

Background:

The V-Go™ is a once-daily disposable device that allows coverage of basal and prandial insulin requirements over a period of 24 hours. The aim of this proof-of-concept study was to evaluate the clinical functionality, safety, and pharmacodynamics of the V-Go delivering insulin aspart and redistributing a single basal dose of insulin glargine as a constant basal infusion supplemented with prandial insulin in subjects with type 2 diabetes mellitus.

Methods:

In six subjects receiving once-daily subcutaneous (SC) injections of insulin glargine (≥15 U/day) with or without concomitant oral antidiabetic drugs, glargine was discontinued following a 3-day baseline phase. The V-Go was then applied to the lower abdomen of the subjects once daily for 7 days (days 1–3 inpatient, days 4–7 outpatient). Each V-Go provided a continuous 24-hour preset basal infusion rate of insulin aspart (0.6 U/h) and up to three daily prandial doses at mealtimes. Capillary blood glucose concentrations were measured at 11 time points per day during the baseline and inpatient phases and at 4 time points per day during the outpatient phase. Additionally, glucose profiles were measured continuously on all days.

Results:

The V-Go was well tolerated and operated as anticipated. The mean ± SEM prestudy daily dose of SC insulin glargine was 33.3 ± 13.8 U; the mean daily total insulin aspart dose infused with the V-Go was 31.5 ± 7.5 and 32.3 ± 7.8 U for the inpatient and outpatient periods, respectively. Fasting blood glucose values were similar to those observed at baseline throughout the study, with nonsignificant (NS) reductions in readings collected during the outpatient phase before lunch (−35 ± 27 mg/dl) and before dinner (−38 ± 25 mg/dl). The 2-hour postprandial glucose trended lower from 231 to 195 mg/dl (NS) at breakfast, 234 to 166 mg/dl (NS) at lunch, and 222 to 171 mg/dl (NS) at dinner. Bedtime blood glucose decreased (mean change from baseline −52 ± 21 mg/dl; P = 0.0313), as did nighttime (3:00 AM) measurements (−20 ± 9 mg/dl; P = 0.0313). Overall glycemic control tended to improve, as shown by continuous glucose monitoring changing from 173 to 157 mg/dl ( P = 0.063, NS) and 156 mg/dl ( P = 0.219) during inpatient and outpatient periods, respectively. Glycemic variability assessed by the M value similarly tended to decrease from 33 ± 9 to 25 ± 4 (NS) and 21 ± 4 (NS) for inpatient and outpatient periods, respectively.

Conclusions:

These first data suggest that use of the V-Go is an attractive alternative to SC insulin injection therapy because metabolic control appears to be maintained or even improved without increasing daily insulin doses.
Randomized Forced Titration to Different Doses of Technosphere® Insulin Demonstrates Reduction in Postprandial Glucose Excursions and Hemoglobin A1c in Patients with Type 2 Diabetes
Authors: Tack Cees J. , Christov Vladimir , de Galan Bastiaan E. , Derwahl Karl-Michael , Klausmann Gerhard , Pelikánová Terezie , Perušičová Jindra , Boss Anders H. , Amin Nikhil , Kramer David , Petrucci Richard , Yu Wen , Yu Wen ,   The 005 Study Group
Published: January 2014

Background:

Individuals with type 2 diabetes mellitus have impairments in early insulin release, resulting in increased postprandial glucose excursions and suboptimal glycemic control. Studies with Technosphere® Insulin (TI) indicate that it has rapid systemic absorption and a short duration of glucose-lowering activity, making it well suited for controlling postprandial glucose levels.

Methods:

The goal of this phase 2b, prospective, multicenter, double-blind, placebo-controlled study was to characterize the dose response of four different doses (equivalent to 3.6, 7.3, 10.9, and 14.6 U subcutaneous regular human insulin) of prandial TI or Technosphere powder alone administered before each of three meals daily, in combination with insulin glargine over an 11-week treatment period, in patients with type 2 diabetes and suboptimal glycemic control.

Conclusions:

This study demonstrated that, over 11 weeks, TI plus basal insulin glargine is well tolerated and results in dose-dependent reductions in postprandial glucose and HbA1c levels.

Results:

The study enrolled 227 patients. In all dose groups, TI demonstrated statistically significant dose-dependent reductions in hemoglobin A1c (HbAlc) versus baseline (−0.4, −0.5, −0.5, and −0.6 for 3.6, 7.3, 10.9, and 14.6 U equivalents, respectively; p < 0.05 in all groups), as well as versus placebo or Technosphere powder alone (−0.40, −0.67, −0.70, and −0.78 for 3.6, 7.3, 10.9, and 14.6 U equivalents, respectively; p < 0.04 in all groups). It reduced the postprandial maximum glucose concentration within each treatment group (statistically significant in all but the TI 3.6 U-equivalent group) and reduced the postprandial area under the glucose curve (statistically significant for the TI 10.9 and 14.6 U-equivalent groups) versus placebo. There were no cases of severe hypoglycemia, while mild/moderate hypoglycemia was observed most frequently in the highest dosage groups, as expected. Rates of cough were low and comparable among all groups. No clinically relevant changes in pulmonary function tests, body weight, or high-resolution computerized axial tomography and magnetic resonance imaging were observed.
Analysis

: Mobile Phones Integrated into Diabetes Management: A Logical Progression
Authors: Malasanos Toree
Published: January 2014

In this issue of Journal of Diabetes Science and Technology, the intervention described by D. Katz, “Novel Interactive Cell-Phone Technology for Health Enhancement,” uses cell phones to provide the rapid communication necessary for the support of intensive management of diabetes. Mobile technology is widely accepted in today's society and can be an effective tool for this cause. There have been numerous interventions using various communication tools, including cell phones, to manage chronic disease, which all propose that improved communication and feedback to patients would improve health status. Dr. Katz has taken the next step by giving semiautomated, real-time, immediate feedback on each data point all transmitted by cell phone.
Peculiarities of the Continuous Glucose Monitoring Data Stream and Their Impact on Developing Closed-Loop Control Technology
Authors: Kovatchev Boris , Clarke William
Published: January 2014

Therapeutic advances in type 1 diabetes (T1DM) are currently focused on developing a closed-loop control system using a continuous glucose monitor (CGM), subcutaneous insulin delivery, and a control algorithm. Because a CGM assesses blood glucose indirectly (and therefore often inaccurately), it limits the effectiveness of the controller. In order to improve the quality of CGM data, a series of analyses are suggested. These analyses evaluate and compensate for CGM errors, assess risks associated with glucose variability, predict glucose fluctuation, and forecast hypo- and hyperglycemia. These analyses are illustrated with data collected using the MiniMed CGMS® (Medtronic, Northridge, CA) and Freestyle Navigator™ (Abbott Diabetes Care, Alameda, CA). It is important to remember that traditional statistics do not work with CGM data because consecutive CGM readings are highly interdependent.
Insulin Analogues: A Critical View on Their Future
Authors: Heinemann Lutz
Published: January 2014

Insulin analogues represent a class of insulin formulations with improved pharmacokinetic and pharmacodynamic properties. The introduction of rapid-acting and long-acting insulin analogues into the market in the last decade has helped optimize metabolic control in patients with diabetes. Unfortunately, the number of good randomized controlled clinical trials (RCTs) that fulfill rigid criteria brought up by evidence-based medicine is low. The consequence is that reimbursement has become an issue, at least in some European countries. In addition to some principal questions about the validity of RCTs to provide the best possible evidence for each and every clinically relevant question, one wonders about the end points of such studies. Other end points, may they be long-term end points such as morbidity and mortality or other short-term end points such as variability in blood glucose levels, are probably more relevant for patients with diabetes. The question is who will fund new clinical studies? From my point of view we will have to start over again on this topic, employing a fresh look on this story. Discussing old data and strategies over and over again will not provide us with the answers needed for the (critical!) evaluation of new diagnostic and therapeutic development.
Evaluation of the VIA® Blood Chemistry Monitor for Glucose in Healthy and Diabetic Volunteers
Authors: Ganesh Arjunan , Hipszer Brian , Loomba Navdeep , Simon Barbara , Torjman Marc C. , Joseph Jeffrey
Published: January 2014

Background:

Manual methods of blood glucose monitoring are labor-intensive, costly, prone to error, and expose the caregiver to blood. The VIA® blood chemistry monitor for glucose can automatically measure plasma glucose (PG) every 5 minutes for 72 hours using blood sampled from a peripheral vein/artery or a central vein.

Methods:

VIA performance was evaluated in eight normal and five type 1 diabetic (T1DM) subjects in 15 separate experiments. The VIA device was connected to a peripheral vein and reported a PG value every 5 minutes during each 510-minute experiment. Blood samples were collected manually every 10 minutes and assayed using a HemoCue® β-glucose analyzer (HC). Whole blood HC measurements were corrected to PG values. Paired HC/VIA measurements ( n = 717) were analyzed.

Results:

Mean PG was 90 ± 14 and 96 ± 12 mg/dl in normal subjects and 194 ± 64 and 173 ± 48 mg/dl in T1DM subject as measured by the HC and VIA, respectively. Clark error grid analysis revealed 86% points in zone A, 11% points in zone B, and 2% points in zone D. Linear regression analysis yielded the following equation: VIA = 0.732 × HC + 30.5 ( r2 = 0.954). Residual analysis revealed a glucose-dependent bias between the HC and the VIA. VIA data were transformed using the linear regression equation to correct for bias. After the correction, the mean absolute relative difference between the VIA and the HC was less than 10%, and 99.6% of data were in zones A and B. The VIA was able to sample blood automatically every 5 minutes for more than 8 hours in the laboratory setting. On average, the VIA reported glucose values for 94% of the samples it attempted to obtain.

Conclusions:

This study demonstrated that the VIA blood chemistry monitor for glucose can reliably sample blood frequently for a prolonged period of time safely and effectively in diabetic and nondiabetic volunteers. Agreement between the two devices was the closest at normal glucose concentrations. After correcting for a glucose-dependent bias between the devices, the MARD was consistently less than 10% for all glucose ranges.
Automated Blood Sampling and Glucose Sensing in Critical Care Settings
Authors: Kunjan Kislaya , Lloyd Frank P.
Published: January 2014

Background:

Tight glycemic control (TGC) studies in intensive care units (ICU) have shown substantial improvements in clinical outcomes. However, implementation of TGC in ICU practice is partly constrained by the lack of automated continuous blood glucose monitoring systems that can facilitate clinically accurate feedback of glycemic data. The aim of this work is to develop a portable automated blood sampling system for integration with a glucose sensor for use in critical care settings.

Methods:

Clinical prototypes for glucose sensing in blood were developed based on two distinct technologies: mid-infrared laser absorption spectroscopy and electrochemistry. Concurrently, an automated peripheral venous blood sampling system was developed for integration with the glucose sensing system.

Results:

The glucose sensing prototypes were validated clinically with various biological samples in a continuous mode. A customized micropump was employed in conjunction with a novel peripheral venous catheter system to automatically sample blood from the subject's forearm. Microvolumes of blood were sampled in continuous and intermittent modes at clinically relevant user-defined frequencies. The clinical feasibility of blood sampling, along with continuous glucose sensing, was demonstrated.

Conclusion:

Cascade's automated peripheral venous blood sampling system, in combination with a flow-through glucose sensor system, offers several advantages over current state-of-the-art systems. This includes the potential for significantly improved workflow in the ICU, minimal discomfort to the patient, and accurate glucose measurement in whole blood, thus helping achieve tight glycemic control.