bluuebunny/crossref_metadata_2025_split huggingface dataset:
Metabolic Biofouling of Glucose Sensors in Vivo: Role of Tissue Microhemorrhages
Authors: Klueh Ulrike , Liu Zenghe , Feldman Ben , Henning Timothy P. , Cho Brian , Ouyang Tianmei , Kreutzer Don 
Published: January 2014

Objective: Based on our in vitro study that demonstrated the adverse effects of blood clots on glucose sensor function, we hypothesized that in vivo local tissue hemorrhages, induced as a consequence of sensor implantation or sensor movement post-implantation, are responsible for unreliable readings or an unexplained loss of functionality shortly after implantation. Research Design and Methods: To investigate this issue, we utilized real-time continuous monitoring of blood glucose levels in a mouse model. Direct injection of blood at the tissue site of sensor implantation was utilized to mimic sensor-induced local tissue hemorrhages. Results: It was found that blood injections, proximal to the sensor, consistently caused lowered sensor glucose readings, designated temporary signal reduction, in vivo in our mouse model, while injections of plasma or saline did not have this effect. Conclusion: These results support our hypothesis that tissue hemorrhage and resulting blood clots near the sensor can result in lowered local blood glucose concentrations due to metabolism of glucose by the clot. The lowered local blood glucose concentration led to low glucose readings from the still functioning sensor that did not reflect the systemic glucose level.
The Effect of Real-Time Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Mellitus
Authors: Ehrhardt Nicole M. , Chellappa Mary , Walker M. Susan , Fonda Stephanie J. , Vigersky Robert A. 
Published: January 2014

Background: Real-time continuous glucose monitoring (RT-CGM) improves hemoglobin A1c (A1C) and hypoglycemia in people with type 1 diabetes mellitus and those with type 2 diabetes mellitus (T2DM) on prandial insulin; however, it has not been tested in people with T2DM not taking prandial insulin. We evaluated the utility of RT-CGM in people with T2DM on a variety of treatment modalities except prandial insulin. Methods: We conducted a prospective, 52-week, two-arm, randomized trial comparing RT-CGM ( n = 50) versus self-monitoring of blood glucose (SMBG) ( n = 50) in people with T2DM not taking prandial insulin. Real-time continuous glucose monitoring was used for four 2-week cycles (2 weeks on/1 week off). All patients were managed by their usual provider. This article reports on changes in A1C 0–12 weeks. Results: Mean (±standard deviation) decline in A1C at 12 weeks was 1.0% (±1.1%) in the RT-CGM group and 0.5% (±0.8%) in the SMBG group ( p = .006). There were no group differences in the net change in number or dosage of hypoglycemic medications. Those who used the RT-CGM for ±48 days (per protocol) reduced their A1C by 1.2% (±1.1%) versus 0.6% (±1.1%) in those who used it <48 days ( p = .003). Multiple regression analyses statistically adjusting for baseline A1C, an indicator for usage, and known confounders confirmed the observed differences between treatment groups were robust ( p = .009). There was no improvement in weight or blood pressure. Conclusions: Real-time continuous glucose monitoring significantly improves A1C compared with SMBG in patients with T2DM not taking prandial insulin. This technology might benefit a wider population of people with diabetes than previously thought.
Use of a Novel Fluorescent Glucose Sensor in Volunteer Subjects with Type 1 Diabetes Mellitus
Authors: Peyser Thomas , Zisser Howard , Khan Uzma , Jovanovic Lois , Bevier Wendy , Romey Matt , Suri Jeff , Strasma Paul , Tiaden Stephanie , Gamsey Soya 
Published: January 2014

Background: Stress hyperglycemia in the critically ill has been found to be associated with increased morbidity and mortality. Studies have found significant improvements in morbidity and mortality in postsurgical patients whose glucose levels were closely maintained in the euglycemic range. However, subsequent studies, in particular the Normoglycemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation (NICE-SUGAR) study, found no improvement in subjects with tight glycemic control. In addition to differences in protocol design, patients in the tight glycemic control arm of the NICE-SUGAR study experienced high rates of hypoglycemia compared with other studies. One interpretation of the NICE-SUGAR study results is that it is difficult to achieve normal glycemia in critically ill patients with existing glucose monitoring technology. The purpose of the study reported here was to evaluate the safety and performance of a continuous intravascular glucose sensor that could be used in the future in critically ill patients. Methods: A first-generation prototype of an intravascular continuous glucose sensor was evaluated in 29 volunteer subjects with type 1 diabetes mellitus. The sensor operates on the principle of quenched fluorescence. The fluorescent emission from the sensor chemistry is nonlinear, resulting in improved accuracy in the hypoglycemic range. The duration of each study was 8 hours. Sensor output was compared with temporally correlated reference measurements made from venous samples on a laboratory glucose analyzer. Results: Data were obtained from 18 of the 29 subjects in the study. Data were analyzed retrospectively using a factory calibration plus a one-point in vivo calibration. The mean absolute relative difference was 7.97%, and 95.1% of all the points were in zone A of the Clarke error grid. Conclusions: This pilot study was the first use in human subjects of a prototype of the GluCath Intravascular Continuous Glucose Monitoring System (GluCath System). The GluCath System is based on a novel fluorescent sensor chemistry. The study found the GluCath System had a high level of accuracy as compared with a laboratory reference analyzer.
Patient Understanding of Diabetes Self-Management: Participatory Decision-Making in Diabetes Care
Authors: Quinn Charlene C. , Royak-Schaler Renee , Lender Dan , Steinle Nanette , Gadalla Shahinaz , Zhan Min 
Published: January 2014

Objective: Our aim was to determine whether patient participation in decision-making about diabetes care is associated with understanding of diabetes self-management and subsequent self-care practices. We also identified issues that would impact messaging for use in mobile diabetes communication. Research Design and Methods: A cross-sectional observational study was conducted with type 2 diabetes patients ( n = 81) receiving their care at the University of Maryland Joslin Diabetes Center. A convenience sample of patients were eligible to participate if they were aged 25–85 years, had type 2 diabetes, spoke English, and visited their physician diabetes manager within the past 6 months. In-person patient interviews were conducted at the time of clinic visits to assess patient understanding of diabetes management, self-care practices, and perceptions of participation in decision-making about diabetes care. Results: African Americans reported fewer opportunities to participate in decision-making than Caucasians, after controlling for education [mean difference (MD) = −2.4, p = .02]. This association became insignificant After controlling for patient-physician race concordance (MD = −1.5, p = .21). Patient understanding of self-care was predicted by having greater than high school education (MD = 3.6, p = .001) and having physicians who involved them in decision-making about their care. For each unit increase in understanding of diabetes self-care, the mean patient self-care practice score increased by 0.16 ( p = .003), after adjustment for patient race and education. Conclusions: Patient participation in decision-making is associated with better understanding of care. Participation in decision-making plays a key role in patient understanding of diabetes self-management and subsequent self-care practices. Patients with limited education need specific instruction in foot care, food choices, and monitoring hemoglobin A1c.
Intensive Insulin Therapy in Critically Ill Hospitalized Patients: Making it Safe and Effective
Authors: Klonoff David C. 
Published: January 2014

Intensive insulin therapy (IIT) for hyperglycemia in critically ill patients has become a standard practice. Target levels for glycemia have fluctuated since 2000, as evidence initially indicated that tight glycemic control to so-called normoglycemia (80–110 mg/dl) leads to the lowest morbidity and mortality without hypoglycemic complications. Subsequent studies have demonstrated minimal clinical benefit combined with greater hypoglycemic morbidity and mortality with tight glycemic control in this population. The consensus glycemic targets were then liberalized to the mid 100s (mg/dl). Handheld POC blood glucose (BG) monitors have migrated from the outpatient setting to the hospital environment because they save time and money for managing critically ill patients who require IIT. These devices are less accurate than hospital-grade POC blood analyzers or central laboratory analyzers. Three questions must be answered to understand the role of IIT for defined populations of critically ill patients: (1) How safe is IIT, with various glycemic targets, from the risk of hypoglycemia? (2) How tightly must BG be controlled for this approach to be effective? (3) What role does the accuracy of BG measurements play in affecting the safety of this method? For each state of impaired glucose regulation seen in the hospital, such as hyperglycemia, hypoglycemia, or glucose variability, the benefits, risks, and goals of treatment, including IIT, might differ. With improved accuracy of BG monitors, IIT might be rendered even more intensive than at present, because patients will be less likely to receive inadvertent overdosages of insulin. Greater doses of insulin, but with dosing based on more accurate glucose levels, might result in less hypoglycemia, less hyperglycemia, and less glycemic variability.
Innovations in Technology for the Treatment of Diabetes: Clinical Development of the Artificial Pancreas (an Autonomous System)
Authors: Klonoff David C. , Zimliki Charles L. , Stevens LCDR Alan , Beaston Patricia , Pinkos Arleen , Choe Sally Y. , Arreaza-Rubín Guillermo , Heetderks William 
Published: January 2014

The Food and Drug Administration in collaboration with the National Institutes of Health presented a public workshop to facilitate medical device innovation in the development of the artificial pancreas (or autonomous system) for the treatment of diabetes mellitus on November 10, 2010 in Gaithersburg, Maryland. The purpose of the workshop was to discuss four aspects of artificial pancreas research and development, including: (1) the current state of device systems for autonomous systems for the treatment of diabetes mellitus; (2) challenges in developing this expert device system using existing technology; (3) clinical expectations for these systems; and (4) development plans for the transition of this device system toward an outpatient setting. The patients discussed how clinical science, system components, and regulatory policies will all need to harmonize in order to achieve the goal of seeing an AP product brought forward to the marketplace for patients to use.
Evaluation of a Novel Continuous Glucose Measurement Device in Patients with Diabetes Mellitus across the Glycemic Range
Authors: Morrow Linda , Hompesch Marcus , Tideman Ann M. , Matson Jennifer , Dunne Nancy , Pardo Scott , Parkes Joan L. , Schachner Holly C. , Simmons David A. 
Published: January 2014

Background: This glucose clamp study assessed the performance of an electrochemical continuous glucose monitoring (CGM) system for monitoring levels of interstitial glucose. This novel system does not require use of a trocar or needle for sensor insertion. Method: Continuous glucose monitoring sensors were inserted subcutaneously into the abdominal tissue of 14 adults with type 1 or type 2 diabetes. Subjects underwent an automated glucose clamp procedure with four consecutive post-steady-state glucose plateau periods (40 min each): (a) hypoglycemic (50 mg/dl) (b) hyperglycemic (250 mg/dl), (c) second hypoglycemic (50 mg/dl), and (d) euglycemic (90 mg/dl). Plasma glucose results obtained with YSI glucose analyzers were used for sensor calibration. Accuracy was assessed retrospectively for plateau periods and transition states, when glucose levels were changing rapidly (approximately 2 mg/dl/min). Results: Mean absolute percent difference (APD) was lowest during hypoglycemic plateaus (11.68%, 14.15%) and the euglycemic-to-hypoglycemic transition (14.21%). Mean APD during the hyperglycemic plateau was 17.11%; mean APDs were 18.12% and 19.25% during the hypoglycemic-to-hyperglycemic and hyperglycemic-to-hypoglycemic transitions, respectively. Parkes (consensus) error grid analysis (EGA) and rate EGA of the plateaus and transition periods, respectively, yielded 86.8% and 68.6% accurate results (zone A) and 12.1% and 20.0% benign errors (zone B). Continuous EGA yielded 88.5%, 75.4%, and 79.3% accurate results and 8.3%, 14.3%, and 2.4% benign errors for the euglycemic, hyperglycemic, and hypoglycemic transition periods, respectively. Adverse events were mild and unlikely to be device related. Conclusion: This novel CGM system was safe and accurate across the clinically relevant glucose range.
Real-Life Utilization of Real-Time Continuous Glucose Monitoring: The Complete Picture
Authors: Ramchandani Neesha , Arya Sandeep , Ten Svetlana , Bhandari Sonal 
Published: January 2014

Background: Very few studies to date have analyzed the reasons why some people do not use real-time continuous glucose monitoring (RT-CGM) continuously, especially given its positive glycemic outcomes, or choose not to wear it at all, even after learning about its benefits. Methods: A questionnaire was designed to assess real-life use of and issues surrounding RT-CGM. Hemoglobin A1c (HbA1c) and duration of sensor use were also obtained from the patients' charts. Results: Fifty-eight subjects with type 1 diabetes (T1DM), average age 15.0 ± 4.8 years, T1DM duration 5.7 ± 3.8 years, HbA1c 8.8 ± 2.1%, 50% with RT-CGM, were included in the analysis. Hemoglobin A1c was lower with increased RT-CGM use. Real-time continuous glucose monitoring was ordered to improve control. Users liked the continuous data. The most disliked part was pain and discomfort. Occasional users described RT-CGM as annoying, a hassle, and interfering with their lives. Reasons for discontinuing RT-CGM included problematic equipment and inaccuracy (64%), intrusion in life (36%), and insurance issues (29%). Twenty-one percent of nonusers reported RT-CGM to be inconvenient or a hassle or just did not want it. Fifty-two percent of subjects continue to use RT-CGM despite reported problems. Conclusion: Real-time continuous glucose monitoring is a beneficial tool for improving glycemic control, and many use it despite reported problems and hassles with current devices. However, this technology has not been wholeheartedly embraced by many individuals with T1DM, especially in youngsters, because of issues mentioned here. Based on the findings of this study, it is hoped that improvements will be made to RT-CGM technology so that more people with diabetes will embrace this beneficial tool.
A 16-Week Open-Label, Multicenter Pilot Study Assessing Insulin Pump Therapy in Patients with Type 2 Diabetes Suboptimally Controlled with Multiple Daily Injections
Authors: Frias Juan P. , Bode Bruce W. , Bailey Timothy S. , Kipnes Mark S. , Brunelle Rocco , Edelman Steven V. 
Published: January 2014

Background: We assessed the efficacy, safety, and patient-reported outcomes (PROs) of insulin pump therapy in patients with type 2 diabetes mellitus (T2DM) who were suboptimally controlled with a multiple daily injection (MDI) regimen. Methods: In this subanalysis of a 16-week multicenter study, 21 insulin-pump-naïve patients [age 57 ± 13 years, hemoglobin A1c (A1C) 8.4 ± 1.0%, body weight 98 ± 20 kg, total daily insulin dose 99 ± 65 U, mean ± standard deviation] treated at baseline with MDI therapy with or without oral antidiabetic agents discontinued all diabetes medications except metformin and initiated insulin pump therapy. Insulin was titrated to achieve the best possible glycemic control with the simplest possible dosing regimen. Outcome measures included A1C, fasting and postprandial glucose, body weight, incidence of hypoglycemia, and PROs. Results: Glycemic control improved significantly after 16 weeks: A1C 7.3 ± 1.0% (−1.1 ± 1.2%, p < .001), fasting glucose 133 ± 33mg/dl (−32 ± 74 mg/dl, p < .005), and postprandial glucose 153 ± 35 mg/dl (−38 ± 46 mg/dl, p < .001). At week 16, the mean daily basal, bolus, and total insulin doses were 66 ± 36, 56 ± 40, and 122 ± 72 U (1.2 U/kg), respectively, and 90% of patients were treated with two or fewer daily basal rates. Body weight increased by 2.8 ± 2.6 kg ( p < .001). Mild hypoglycemia was experienced by 81% of patients at least once during the course of the study with no episodes of severe hypoglycemia. There were significant improvements in PRO measures. Conclusions: Insulin pump therapy using a relatively simple dosing regimen safely improved glucose control and PROs in patients with T2DM who were unable to achieve glycemic targets with MDI therapy. Controlled trials are needed to further assess the clinical benefits and cost-effectiveness of insulin pumps in this patient population.
A Stepwise Approach toward Closed-Loop Blood Glucose Control for Intensive Care Unit Patients: Results from a Feasibility Study in Type 1 Diabetic Subjects Using Vascular Microdialysis with Infrared Spectrometry and a Model Predictive Control Algorithm
Authors: Feichtner Franz , Mader Julia K. , Schaller Roland , Schaupp Lukas , Ellmerer Martin , Korsatko Stefan , Kondepati Venkata R. , Heise H. Michael , Wilinska Malgorzata E. , Hovorka Roman , Pieber Thomas R. 
Published: January 2014

Background: Glycemic control can reduce the mortality and morbidity of intensive care patients. The CLINICIP (closed-loop insulin infusion for critically ill patients) project aimed to develop a closed-loop control system for this patient group. Following a stepwise approach, we combined three independently tested subparts to form a semiautomatic closed-loop system and evaluated it with respect to safety and performance aspects by testing it in subjects with type 1 diabetes mellitus (T1DM) in a first feasibility trial. Methods: Vascular microdialysis, a multianalyte infrared spectroscopic glucose sensor, and a standard insulin infusion pump controlled by an adaptive model predictive control (MPC) algorithm were combined to form a closed-loop device, which was evaluated in four T1DM subjects during 30-hour feasibility studies. The aim was to maintain blood glucose concentration in the target range between 80 and 110 mg/dl. Results: Mean plasma glucose concentration was 110.5 ± 29.7 mg/dl. The MPC managed to establish normoglycemia within 105 ± 78 minutes after trial start and managed to maintain glucose concentration within the target range for 47% of the time. The hyperglycemic index averaged to 11.9 ± 5.3 mg/dl. Conclusion: Data of the feasibility trial illustrate the device being effective in controlling glycemia in T1DM subjects. However, the monitoring part of the loop must be improved with respect to accuracy and precision before testing the system in the target population.
Convergence of Prevalence Rates of Diabetes and Cardiometabolic Risk Factors in Middle and Low Income Groups in Urban India: 10-Year Follow-Up of the Chennai Urban Population Study
Authors: Deepa Mohan , Anjana Ranjit Mohan , Manjula Datta , Narayan K.M. Venkat , Mohan Viswanathan 
Published: January 2014

Aim: The aim of this study was to look for temporal changes in the prevalence of diabetes and cardiometabolic risk factors in two residential colonies in Chennai. Methods: Chennai Urban Population Study (CUPS) was carried out between 1996–1998 in Chennai in two residential colonies representing the middle income group (MIG) and lower income group (LIG), respectively. The MIG had twice the prevalence rate of diabetes as the LIG and higher prevalence rates of hypertension, obesity, and dyslipidemia. They were motivated to increase their physical activity, which led to the building of a park. The LIG was given standard lifestyle advice. Follow-up surveys of both colonies were performed after a period of 10 years. Results: In the MIG, the prevalence of diabetes increased from 12.4 to 15.4% (24% increase), while in the LIG, it increased from 6.5 to 15.3% (135% increase, p < .001). In the LIG, the prevalence rates of central obesity (baseline vs follow-up, male: 30.8 vs 50.9%, p < .001; female: 16.9 vs 49.8%, p < .001), hypertension (8.4 vs 20.1%, p < .001), hypercholesterolemia (14.2 vs. 20.4%, p < .05), and hypertriglyceridemia (8.0 vs 23.5%, p < .001) significantly increased and became similar to that seen in the MIG. Conclusion: There is a rapid reversal of socioeconomic gradient for diabetes and cardiometabolic risk factors in urban India with a convergence of prevalence rates among people in the MIG and LIG. This could have a serious economic impact on poor people in developing countries such as India.
Diabetes and Technology for Increased Activity (DaTA) Study: Results of a Remote Monitoring Intervention for Prevention of Metabolic Syndrome
Authors: Stuckey Melanie , Russell-Minda Elizabeth , Read Emily , Munoz Claudio , Shoemaker Kevin , Kleinstiver Peter , Petrella Robert 
Published: January 2014

Objective: An increasingly aged, overweight, and sedentary population has resulted in elevated risk of cardiovascular disease (CVD). The escalating incidence of diabetes and other chronic illnesses, deficits in health care budgets, and physician shortages, especially in rural communities, have prompted investigations of feasible solutions. The Diabetes and Technology for Increased Activity (DaTA) study was designed to test the effectiveness of a lifestyle intervention driven by self-monitoring of blood glucose (BG), blood pressure (BP), physical activity (PA), and weight to positively impact CVD risk factors in a medically underserviced rural population with a high incidence of metabolic syndrome (MS). Research Design and Methods: Conducted in a community-based research setting, this single-center open feasibility study used smart phones to transmit BP, BG, pedometer, weight, heart rate, and activity measurements to a database. Technology allowed participants to interface with the clinical team and self-monitor their personal health indicators. Results: Twenty-four participants aged 30 to 71 years completed the 8-week intervention. Participants had significant improvement in clinic ( p = .046) and self-monitored diastolic BP ( p = .001), body mass index ( p = .002), and total cholesterol ( p = .009), and steps per day. Daily PA increased as well as participants' interest in and willingness to make lifestyle changes that impact health outcomes. Conclusions: The DaTA study demonstrated that self-monitoring of the risk factors for MS and increased PA improved the participant's CVD risk profile. Considering the 8-week time period of this intervention, results are encouraging. This lifestyle intervention, which uses education and technology as tools, confirms the utility of remote health monitoring.